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| ID | Type | Description | Link |
|---|---|---|---|
| 2U24HD069031-06 | U.S. NIH Grant/Contract | View source | |
| 2UG1HD069013-06 | U.S. NIH Grant/Contract | View source | |
| 5UG1HD041267-18 | U.S. NIH Grant/Contract | View source | |
| 5UG1HD069010-07 | U.S. NIH Grant/Contract | View source | |
| 5UG1HD069006-07 | U.S. NIH Grant/Contract | View source | |
| 5UG1HD041261-17 | U.S. NIH Grant/Contract | View source | |
| 5UG1HD054214-12 | U.S. NIH Grant/Contract | View source | |
| 5UG1HD054241-12 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Alabama at Birmingham | OTHER |
| University of California, San Diego | OTHER |
| Duke University | OTHER |
| Women and Infants Hospital of Rhode Island |
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This study is a multi-center, randomized clinical trial of women with refractory accidental bowel leakage (ABL) symptoms who have failed to achieve satisfactory symptom control from 2 first-line treatments for ABL: supervised pelvic muscle training (PMT) and constipating medication. The purpose of this study is to compare percutaneous tibial nerve stimulation (PTNS) to a validated sham to determine if PTNS is effective for the treatment of fecal incontinence (FI) in women.
The investigators will test the null hypothesis that change from baseline in St. Mark's (Vaizey) score after 12 weeks of stimulation is not significantly different in women with symptomatic ABL receiving PTNS treatments compared to women receiving sham PTNS treatments.
The overarching goal of this randomized clinical trial is to determine if PTNS is more effective than sham PTNS for the treatment of FI in women after 12 weeks of treatment and 1 year after initiating treatment. This is a two-part trial with a Run-In Phase prior to randomization. The trial has the following primary aim:
To determine whether the change from baseline in St. Mark's (Vaizey) score in women with symptomatic ABL undergoing PTNS differs from sham after 12 weeks of stimulation.
Additional secondary aims include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Percutaneous Tibial Nerve Stimulation (PTNS) | Experimental | PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. |
|
| Validated Sham | Sham Comparator | Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ES-130 | Device | The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline St. Mark's (Vaizey) Score | The primary outcome measure is the change from baseline in St. Mark's (Vaizey) Score 12 weeks after treatment initiation to compare the outcomes of post-tibial nerve stimulation (PTNS) versus sham stimulation. The St. Mark's (Vaizey) score, published in 1999, is commonly used in clinical studies and reports and was based on the Jorge-Wexner score but added two further items for assessment: the use of constipating medication and the presence of fecal urgency. Minimum score is 0 = perfect continence; maximum score is 24 = totally incontinent. Change from baseline is calculated as Week [4, 8, or 12] Score minus the score at baseline. | 4, 8, and 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Responder to Treatment | Responder status is based on the primary chnage from St. Mark's Score. A responder is defined as any particpant with at least a 4 point reduction in score compared to their baseline score | 4, 8, and 12 Weeks |
| Change From Baseline Number of Fecal Incontinence Events Per Week |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline ABLe Liquid Score | The ABLE Liquid Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of liquid stool. Minimum score is 0 = no problem with liquid stool leakage; maximum score is 4 = frequent, bothersome leakage of large amounts of liquid stool. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Halina M Zyczynski, MD | Magee-Women's Hospital, Department of Obstetrics and Gynecology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233-7333 | United States | ||
| Kaiser Permanente -- Downey |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35354778 | Derived | Zyczynski HM, Richter HE, Sung VW, Lukacz ES, Arya LA, Rahn DD, Visco AG, Mazloomdoost D, Carper B, Gantz MG; NICHD Pelvic Floor Disorders Network. Percutaneous Tibial Nerve Stimulation vs Sham Stimulation for Fecal Incontinence in Women: NeurOmodulaTion for Accidental Bowel Leakage Randomized Clinical Trial. Am J Gastroenterol. 2022 Apr 1;117(4):654-667. doi: 10.14309/ajg.0000000000001605. | |
| 33950027 | Derived | Zyczynski HM, Arya LA, Lukacz ES, Richter HE, Rahn DD, Sung VW, Visco AG, Shaffer A, Jelovsek JE, Rogers R, Mazloomdoost D, Gantz MG; Eunice Kennedy Shriver NICHD Pelvic Floor Disorders Network (PFDN). Design of a Randomized Controlled Trial of Percutaneous Posterior Tibial Nerve Stimulation for the Treatment of Refractory Fecal Incontinence in Women: The NeurOmodulaTion for Accidental Bowel Leakage Study. Female Pelvic Med Reconstr Surg. 2021 Dec 1;27(12):726-734. doi: 10.1097/SPV.0000000000001050. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Percutaneous Tibial Nerve Stimulation (PTNS) | PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device. |
| FG001 | Validated Sham | Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PTNS | PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline St. Mark's (Vaizey) Score | The primary outcome measure is the change from baseline in St. Mark's (Vaizey) Score 12 weeks after treatment initiation to compare the outcomes of post-tibial nerve stimulation (PTNS) versus sham stimulation. The St. Mark's (Vaizey) score, published in 1999, is commonly used in clinical studies and reports and was based on the Jorge-Wexner score but added two further items for assessment: the use of constipating medication and the presence of fecal urgency. Minimum score is 0 = perfect continence; maximum score is 24 = totally incontinent. Change from baseline is calculated as Week [4, 8, or 12] Score minus the score at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | units on a scale | 4, 8, and 12 Weeks |
|
12 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PTNS | PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA 17.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 17.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marie Gantz | RTI International | 919-597-5110 | mgantz@rti.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 3, 2019 | Mar 23, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 28, 2020 | Mar 23, 2021 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 28, 2018 | May 16, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| OTHER |
| RTI International | OTHER |
| University of Pennsylvania | OTHER |
| University of Pittsburgh | OTHER |
| Kaiser Permanente | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| University of Texas Southwestern Medical Center | OTHER |
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Participants will remain masked to subject treatment assignment throughout the trial. To maintain masking of participants, the duration of treatment sessions for both the PTNS and sham groups will be 30 minutes and will be conducted with subjects in a supine position with the knees comfortably abducted and flexed. The leg and foot involved in treatment will be obscured from the subject's view with a portable anesthesia drape frame to which an exam sheet will be secured.
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Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of fecal incontinence episodes per week at 8 and 12 weeks and the number of fecal incontinence episodes at baseline. |
| 8 and 12 Weeks |
| Change From Baseline Number of Urge Fecal Incontinence Events Per Week | Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of urge fecal incontinence episodes per week at 8 and 12 weeks and the number of urge fecal incontinence episodes at baseline. | 8 and 12 Weeks |
| Change From Baseline Number of Bowel Movements Per Week | Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of bowel movements per week at 8 and 12 weeks and the number of bowel movements at baseline. | 8 and 12 Weeks |
| Change From Baseline Number of Urge Bowel Movements Per Week | Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of urge bowel movements per week at 8 and 12 weeks and the number of urge bowel movements at baseline. | 8 and 12 Weeks |
| Change From Baseline Number of Days Without Fecal Incontinence Episodes Per Week | Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of days without fecal incontinence episodes per week at 8 and 12 weeks and the number of days without fecal incontinence episodes at baseline. | 8 and 12 Weeks |
| 50% Improvement in Fecal Incontinence Episodes Per Week | Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome is calculated as any participant with a 50% reduction in fecal incontinence episodes per week at 8 and 12 weeks compared to the fecal incontinence episodes at baseline | 8 and 12 Weeks |
| 75% Improvement in Fecal Incontinence Episodes Per Week | Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome is calculated as any participant with a 75% reduction in fecal incontinence episodes per week at 8, and 12 weeks compared to the fecal incontinence episodes at baseline. | 8 and 12 Weeks |
| Patient Global Impression-Improvement | The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had improvement as indicated by a rating of 1 (very much better) or 2 (much better) | 4, 8, and 12 Weeks |
| 8 and 12 Weeks |
| Change From Baseline ABLe Solid Score | The ABLE Solid Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of solid stool. Minimum score is 0 = no problem with solid stool leakage; maximum score is 4 = frequent, bothersome leakage of large amounts of solid stool. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. | 8 and 12 Weeks |
| Change From Baseline ABLe Mucus Score | The ABLE Mucus Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of mucus from the rectum. Minimum score is 0 = no problem with mucus leakage from the rectum; maximum score is 4 = frequent, bothersome leakage of large amounts of mucus from the rectum. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. | 8 and 12 Weeks |
| Change From Baseline ABLe Gas Score | The ABLE Gas Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of gas from the rectum. Minimum score is 0 = no problem with gas leakage from the rectum; maximum score is 4 = frequent and bothersome leakage of gas from the rectum. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. | 8 and 12 Weeks |
| Change From Baseline ABLe Predictability/Awareness Score | The ABLE Predictability/Awareness Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the predictability of bowel leakage events. Minimum score is 0 = no problems with leakage; maximum score is 4 = leakage without awareness or predictability. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. | 8 and 12 Weeks |
| Change From Baseline ABLe Control Score | The ABLE Control Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the ability to control bowel movements. Minimum score is 0 = no problems with urgency to empty bowels wthout warning; maximum score is 4 = frequent and bothersome urgency to empty bowels wthout warning. | 8 and 12 Weeks |
| Change From Baseline ABLe Ancillary Bowel Symptoms Score | The ABLE Ancillary Bowel Symptoms Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the frequency and impact of ancially bowel symptoms. Minimum score is 0 = no problems with pain or incomplete emptying; maximum score is 4 = frequent and bothersome pain or incomplete emptying. | 8 and 12 Weeks |
| Change From Baseline ABLe Overall Score | The ABLE Overall Score is the summary score of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the frequency and impact of accidental bowel leakage and related symptoms. Minimum score is 0 = no problems with bowel leakage and related symptoms; maximum score is 4 = frequent and bothersome problems with bowel leakage and related symptoms. | 8 and 12 Weeks |
| Patient Global Symptom Control | The Patient Global Symptom Control (PGSC) is a patient-reported measure of perceived agreement that symptoms are under control, as assessed on a scale of 1 (Disagree Strongly) to 5 (Agree Strongly). Included here are participants who had reported disagreements as indicated by a rating of 1 (Disagree Strongly) or 2 (Disagree) | Baseline and 4, 8, and 12 Weeks |
| Change From Baseline FIQL Lifestyle Score | The FIQL Lifestyle Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. | 8 and 12 Weeks |
| Change From Baseline FIQL Coping Score | The FIQL Coping Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. | 8 and 12 Weeks |
| Change From Baseline FIQL Depression Score | The FIQL Depression Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. | 8 and 12 Weeks |
| Change From Baseline FIQL Embarrassment Score | The FIQL Embarrassment Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. | 8 and 12 Weeks |
| Change From Baseline FISI Patient Score | The FISI Patient Score is a summary score of the validated Fecal Incontinence Severity Index questionnaire which provides a summary metric of the severity of fecal incontinence from the patient's perspective. Minimum score is 0 = no fecal incontinence; maximum score is 61 = very severe fecal incontinence. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. | 8 and 12 Weeks |
| Change From Baseline FISI Doctor Score | The FISI Doctor Score is a summary score of the validated Fecal Incontinence Severity Index questionnaire which provides a summary metric of the severity of fecal incontinence from the doctor's perspective. Minimum score is 0 = no fecal incontinence; maximum score is 57 = very severe fecal incontinence. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. | 8 and 12 Weeks |
| Change From Baseline MMHQ Incontinence Impact Score | The MMHQ Incontinence Impact Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. | 8 and 12 Weeks |
| Change From Baseline MMHQ Role Limitations Score | The MMHQ Role Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. | 8 and 12 Weeks |
| Change From Baseline MMHQ Physical Limitations Score | The MMHQ Physical Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. | 8 and 12 Weeks |
| Change From Baseline MMHQ Social Limitations Score | The MMHQ Social Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. | 8 and 12 Weeks |
| Change From Baseline MMHQ Personal Relationship Score | The MMHQ Personal Relationship Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. | 8 and 12 Weeks |
| Change From Baseline MMHQ Emotional Function Score | The MMHQ Emotional Function Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. | 8 and 12 Weeks |
| Change From Baseline MMHQ Sleep/Energy Score | The MMHQ Sleep/Energy Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. | 8 and 12 Weeks |
| Change From Baseline MMHQ Severity Measures Score | The MMHQ Severity Measures Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. | 8 and 12 Weeks |
| Change From Baseline CRAIQ Score | The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week [8, 12] Score - Baseline Score). Lower scores indicate better function / fewer symptoms. | 8 and 12 Weeks |
| Change From Baseline POPIQ Score | The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week [8, 12] Score - Baseline Score). Lower scores indicate better function / fewer symptoms. | 8 and 12 Weeks |
| Change From Baseline UIQ Score | The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week [8, 12] Score - Baseline Score). Lower scores indicate better function / fewer symptoms. | 8 and 12 Weeks |
| Change From Baseline PFIQ Score | The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week [8, 12] Score - Baseline Score). Lower scores indicate better function / fewer symptoms. | 8 and 12 Weeks |
| Change From Baseline PAC-SYM Abdominal Score | The Patient Assessment of Constipation - Symptom (PAC-SYM) ia a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-mising responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very sever). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation. | 12 Weeks |
| Change From Baseline PAC-SYM Rectal Score | The Patient Assessment of Constipation - Symptom (PAC-SYM) ia a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-mising responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very sever). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation. | 12 Weeks |
| Change From Baseline PAC-SYM Stool Score | The Patient Assessment of Constipation - Symptom (PAC-SYM) ia a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-mising responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very sever). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation. | 12 Weeks |
| Change From Baseline PAC-SYM Total Score | The Patient Assessment of Constipation - Symptom (PAC-SYM) is a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-missing responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very severe). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation. | 12 Weeks |
| Change From Baseline PISQ-IR NSA-PR Score | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Partner Related (NSA-PR) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. | 12 Weeks |
| Change From Baseline PISQ-IR NSA-CS Score | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Condition Specific (NSA-CS) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. | 12 Weeks |
| Change From Baseline PISQ-IR NSA-GQA Score | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Global Quality Rating (NSA-GQA) ranges from 1 to 4.5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. | 12 Weeks |
| Change From Baseline PISQ-IR NSA-CI Score | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Condition Impact (NSA-CI) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. | 12 Weeks |
| Change From Baseline PISQ-IR SA-AO Score | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Arousal Orgasm (SA-AO) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. | 12 Weeks |
| Change From Baseline PISQ-IR SA-PR Score | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Partner Related (SA-PR) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. | 12 Weeks |
| Change From Baseline PISQ-IR SA-CS Score | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Condition Specific (SA-CS) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. | 12 Weeks |
| Change From Baseline PISQ-IR SA-GQR Score | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Global Quality Rating (SA-GQR) ranges from 1 to 4.75 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. | 12 Weeks |
| Change From Baseline PISQ-IR SA-CI Score | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Condition Impact (SA-CI) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. | 12 Weeks |
| Change From Baseline PISQ-IR SA-D Score | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Desire (SA-D) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. | 12 Weeks |
| Change From Baseline PISQ-IR SA-AVG Score | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Average (SA-AVG) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. | 12 Weeks |
| Change From Baseline FIAI Hygiene Index Score | The Fecal Incontinence Adaptation Index (FIAI) is a validated form which measures the adaptation behavios resulting from fecal incontinence. It consists of two subscales: Hygiene (range: 0-100) and Avoidance (range: 0-100). Scores are cal calculated as the average of the non-missing responses multiplied by 25. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. | 12 Weeks |
| Change From Baseline FIAI Avoidance Index Score | The Fecal Incontinence Adaptation Index (FIAI) is a validated form which measures the adaptation behavios resulting from fecal incontinence. It consists of two subscales: Hygiene (range: 0-100) and Avoidance (range: 0-100). Scores are cal calculated as the average of the non-missing responses multiplied by 25. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. | 12 Weeks |
| Change From Baseline SF-12 Aggregate Physical Score | The 12-Item Short-Form Health Survey (SF-12) is a validated survey which assesses overall physical and mental health. The Aggregate Physical Score ranges from 24 to 56.6 with higher scores indicating greater physical health. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. | 12 Weeks |
| Change From Baseline SF-12 Aggregate Mental Score | The 12-Item Short-Form Health Survey (SF-12) is a validated survey which assesses overall physical and mental health. The Aggregate Mental Score ranges from 19.06 to 60.86 with higher scores indicating greater mental health. The outcome is calculated as the difference in score at 12 weeks and the score at baseline | 12 Weeks |
| Downey |
| California |
| 90242 |
| United States |
| University of California at San Diego, UCSD Women's Pelvic Medicine Center | La Jolla | California | 92037-0974 | United States |
| Kaiser Permanente -- San Diego | San Diego | California | 92110 | United States |
| Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery | Durham | North Carolina | 27707 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Magee-Women's Hospital, Department of Obstetrics and Gynecology | Pittsburgh | Pennsylvania | 15213 | United States |
| Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery | Providence | Rhode Island | 02903 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| BG001 | Sham | Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| Current Smoker | Count of Participants | Participants |
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| Ever Pregnant | Count of Participants | Participants |
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| Number of Vaginal Deliveries | Median | Full Range | deliveries per participant |
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| Number of Cesarean Deliveries | Median | Full Range | deliveries per participant |
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| Menstrual Status | Count of Participants | Participants |
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PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.
ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
| OG001 | Sham | Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device. |
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| Secondary | Responder to Treatment | Responder status is based on the primary chnage from St. Mark's Score. A responder is defined as any particpant with at least a 4 point reduction in score compared to their baseline score | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Count of Participants | Participants | 4, 8, and 12 Weeks |
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| Secondary | Change From Baseline Number of Fecal Incontinence Events Per Week | Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of fecal incontinence episodes per week at 8 and 12 weeks and the number of fecal incontinence episodes at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | episodes per week | 8 and 12 Weeks |
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| Secondary | Change From Baseline Number of Urge Fecal Incontinence Events Per Week | Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of urge fecal incontinence episodes per week at 8 and 12 weeks and the number of urge fecal incontinence episodes at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | episodes per week | 8 and 12 Weeks |
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| Secondary | Change From Baseline Number of Bowel Movements Per Week | Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of bowel movements per week at 8 and 12 weeks and the number of bowel movements at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | episodes per week | 8 and 12 Weeks |
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| Secondary | Change From Baseline Number of Urge Bowel Movements Per Week | Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of urge bowel movements per week at 8 and 12 weeks and the number of urge bowel movements at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | episodes per week | 8 and 12 Weeks |
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| Secondary | Change From Baseline Number of Days Without Fecal Incontinence Episodes Per Week | Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of days without fecal incontinence episodes per week at 8 and 12 weeks and the number of days without fecal incontinence episodes at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | episodes per week | 8 and 12 Weeks |
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| Secondary | 50% Improvement in Fecal Incontinence Episodes Per Week | Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome is calculated as any participant with a 50% reduction in fecal incontinence episodes per week at 8 and 12 weeks compared to the fecal incontinence episodes at baseline | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Count of Participants | Participants | 8 and 12 Weeks |
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| Secondary | 75% Improvement in Fecal Incontinence Episodes Per Week | Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome is calculated as any participant with a 75% reduction in fecal incontinence episodes per week at 8, and 12 weeks compared to the fecal incontinence episodes at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Count of Participants | Participants | 8 and 12 Weeks |
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| Secondary | Patient Global Impression-Improvement | The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had improvement as indicated by a rating of 1 (very much better) or 2 (much better) | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Count of Participants | Participants | 4, 8, and 12 Weeks |
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| Other Pre-specified | Change From Baseline ABLe Liquid Score | The ABLE Liquid Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of liquid stool. Minimum score is 0 = no problem with liquid stool leakage; maximum score is 4 = frequent, bothersome leakage of large amounts of liquid stool. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | units on a scale | 8 and 12 Weeks |
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| Other Pre-specified | Change From Baseline ABLe Solid Score | The ABLE Solid Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of solid stool. Minimum score is 0 = no problem with solid stool leakage; maximum score is 4 = frequent, bothersome leakage of large amounts of solid stool. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | units on a scale | 8 and 12 Weeks |
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| Other Pre-specified | Change From Baseline ABLe Mucus Score | The ABLE Mucus Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of mucus from the rectum. Minimum score is 0 = no problem with mucus leakage from the rectum; maximum score is 4 = frequent, bothersome leakage of large amounts of mucus from the rectum. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | units on a scale | 8 and 12 Weeks |
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| Other Pre-specified | Change From Baseline ABLe Gas Score | The ABLE Gas Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of gas from the rectum. Minimum score is 0 = no problem with gas leakage from the rectum; maximum score is 4 = frequent and bothersome leakage of gas from the rectum. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | units on a scale | 8 and 12 Weeks |
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| Other Pre-specified | Change From Baseline ABLe Predictability/Awareness Score | The ABLE Predictability/Awareness Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the predictability of bowel leakage events. Minimum score is 0 = no problems with leakage; maximum score is 4 = leakage without awareness or predictability. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | units on a scale | 8 and 12 Weeks |
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| Other Pre-specified | Change From Baseline ABLe Control Score | The ABLE Control Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the ability to control bowel movements. Minimum score is 0 = no problems with urgency to empty bowels wthout warning; maximum score is 4 = frequent and bothersome urgency to empty bowels wthout warning. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | units on a scale | 8 and 12 Weeks |
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| Other Pre-specified | Change From Baseline ABLe Ancillary Bowel Symptoms Score | The ABLE Ancillary Bowel Symptoms Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the frequency and impact of ancially bowel symptoms. Minimum score is 0 = no problems with pain or incomplete emptying; maximum score is 4 = frequent and bothersome pain or incomplete emptying. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | units on a scale | 8 and 12 Weeks |
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| Other Pre-specified | Change From Baseline ABLe Overall Score | The ABLE Overall Score is the summary score of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the frequency and impact of accidental bowel leakage and related symptoms. Minimum score is 0 = no problems with bowel leakage and related symptoms; maximum score is 4 = frequent and bothersome problems with bowel leakage and related symptoms. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | units on a scale | 8 and 12 Weeks |
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| Other Pre-specified | Patient Global Symptom Control | The Patient Global Symptom Control (PGSC) is a patient-reported measure of perceived agreement that symptoms are under control, as assessed on a scale of 1 (Disagree Strongly) to 5 (Agree Strongly). Included here are participants who had reported disagreements as indicated by a rating of 1 (Disagree Strongly) or 2 (Disagree) | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Count of Participants | Participants | Baseline and 4, 8, and 12 Weeks |
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| Other Pre-specified | Change From Baseline FIQL Lifestyle Score | The FIQL Lifestyle Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | units on a scale | 8 and 12 Weeks |
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| Other Pre-specified | Change From Baseline FIQL Coping Score | The FIQL Coping Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | units on a scale | 8 and 12 Weeks |
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| Other Pre-specified | Change From Baseline FIQL Depression Score | The FIQL Depression Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | units on a scale | 8 and 12 Weeks |
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| Other Pre-specified | Change From Baseline FIQL Embarrassment Score | The FIQL Embarrassment Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | units on a scale | 8 and 12 Weeks |
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| Other Pre-specified | Change From Baseline FISI Patient Score | The FISI Patient Score is a summary score of the validated Fecal Incontinence Severity Index questionnaire which provides a summary metric of the severity of fecal incontinence from the patient's perspective. Minimum score is 0 = no fecal incontinence; maximum score is 61 = very severe fecal incontinence. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | units on a scale | 8 and 12 Weeks |
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| Other Pre-specified | Change From Baseline FISI Doctor Score | The FISI Doctor Score is a summary score of the validated Fecal Incontinence Severity Index questionnaire which provides a summary metric of the severity of fecal incontinence from the doctor's perspective. Minimum score is 0 = no fecal incontinence; maximum score is 57 = very severe fecal incontinence. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | units on a scale | 8 and 12 Weeks |
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| Other Pre-specified | Change From Baseline MMHQ Incontinence Impact Score | The MMHQ Incontinence Impact Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | units on a scale | 8 and 12 Weeks |
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| Other Pre-specified | Change From Baseline MMHQ Role Limitations Score | The MMHQ Role Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | units on a scale | 8 and 12 Weeks |
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| Other Pre-specified | Change From Baseline MMHQ Physical Limitations Score | The MMHQ Physical Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | units on a scale | 8 and 12 Weeks |
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| Other Pre-specified | Change From Baseline MMHQ Social Limitations Score | The MMHQ Social Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | units on a scale | 8 and 12 Weeks |
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| Other Pre-specified | Change From Baseline MMHQ Personal Relationship Score | The MMHQ Personal Relationship Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | units on a scale | 8 and 12 Weeks |
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| Other Pre-specified | Change From Baseline MMHQ Emotional Function Score | The MMHQ Emotional Function Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | units on a scale | 8 and 12 Weeks |
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| Other Pre-specified | Change From Baseline MMHQ Sleep/Energy Score | The MMHQ Sleep/Energy Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | units on a scale | 8 and 12 Weeks |
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| Other Pre-specified | Change From Baseline MMHQ Severity Measures Score | The MMHQ Severity Measures Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | units on a scale | 8 and 12 Weeks |
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| Other Pre-specified | Change From Baseline CRAIQ Score | The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week [8, 12] Score - Baseline Score). Lower scores indicate better function / fewer symptoms. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | units on a scale | 8 and 12 Weeks |
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| Other Pre-specified | Change From Baseline POPIQ Score | The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week [8, 12] Score - Baseline Score). Lower scores indicate better function / fewer symptoms. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | units on a scale | 8 and 12 Weeks |
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| Other Pre-specified | Change From Baseline UIQ Score | The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week [8, 12] Score - Baseline Score). Lower scores indicate better function / fewer symptoms. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | units on a scale | 8 and 12 Weeks |
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| Other Pre-specified | Change From Baseline PFIQ Score | The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week [8, 12] Score - Baseline Score). Lower scores indicate better function / fewer symptoms. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | units on a scale | 8 and 12 Weeks |
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| Other Pre-specified | Change From Baseline PAC-SYM Abdominal Score | The Patient Assessment of Constipation - Symptom (PAC-SYM) ia a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-mising responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very sever). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 Weeks |
|
|
|
| Other Pre-specified | Change From Baseline PAC-SYM Rectal Score | The Patient Assessment of Constipation - Symptom (PAC-SYM) ia a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-mising responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very sever). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 Weeks |
|
|
|
| Other Pre-specified | Change From Baseline PAC-SYM Stool Score | The Patient Assessment of Constipation - Symptom (PAC-SYM) ia a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-mising responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very sever). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 Weeks |
|
|
|
| Other Pre-specified | Change From Baseline PAC-SYM Total Score | The Patient Assessment of Constipation - Symptom (PAC-SYM) is a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-missing responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very severe). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 Weeks |
|
|
|
| Other Pre-specified | Change From Baseline PISQ-IR NSA-PR Score | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Partner Related (NSA-PR) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were not sexually active. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 Weeks |
|
|
|
| Other Pre-specified | Change From Baseline PISQ-IR NSA-CS Score | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Condition Specific (NSA-CS) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were not sexually active. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 Weeks |
|
|
|
| Other Pre-specified | Change From Baseline PISQ-IR NSA-GQA Score | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Global Quality Rating (NSA-GQA) ranges from 1 to 4.5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were not sexually active. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 Weeks |
|
|
|
| Other Pre-specified | Change From Baseline PISQ-IR NSA-CI Score | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Condition Impact (NSA-CI) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected for participants that were not sexually active. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 Weeks |
|
|
|
| Other Pre-specified | Change From Baseline PISQ-IR SA-AO Score | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Arousal Orgasm (SA-AO) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure is only calculated for participants that were sexually active. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 Weeks |
|
|
|
| Other Pre-specified | Change From Baseline PISQ-IR SA-PR Score | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Partner Related (SA-PR) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure is only collected from participants that were sexually active. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 Weeks |
|
|
|
| Other Pre-specified | Change From Baseline PISQ-IR SA-CS Score | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Condition Specific (SA-CS) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were sexually active. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 Weeks |
|
|
|
| Other Pre-specified | Change From Baseline PISQ-IR SA-GQR Score | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Global Quality Rating (SA-GQR) ranges from 1 to 4.75 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were sexually active. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 Weeks |
|
|
|
| Other Pre-specified | Change From Baseline PISQ-IR SA-CI Score | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Condition Impact (SA-CI) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were sexually active. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 Weeks |
|
|
|
| Other Pre-specified | Change From Baseline PISQ-IR SA-D Score | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Desire (SA-D) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were sexually active. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 Weeks |
|
|
|
| Other Pre-specified | Change From Baseline PISQ-IR SA-AVG Score | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Average (SA-AVG) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were sexually active. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 Weeks |
|
|
|
| Other Pre-specified | Change From Baseline FIAI Hygiene Index Score | The Fecal Incontinence Adaptation Index (FIAI) is a validated form which measures the adaptation behavios resulting from fecal incontinence. It consists of two subscales: Hygiene (range: 0-100) and Avoidance (range: 0-100). Scores are cal calculated as the average of the non-missing responses multiplied by 25. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 Weeks |
|
|
|
| Other Pre-specified | Change From Baseline FIAI Avoidance Index Score | The Fecal Incontinence Adaptation Index (FIAI) is a validated form which measures the adaptation behavios resulting from fecal incontinence. It consists of two subscales: Hygiene (range: 0-100) and Avoidance (range: 0-100). Scores are cal calculated as the average of the non-missing responses multiplied by 25. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 Weeks |
|
|
|
| Other Pre-specified | Change From Baseline SF-12 Aggregate Physical Score | The 12-Item Short-Form Health Survey (SF-12) is a validated survey which assesses overall physical and mental health. The Aggregate Physical Score ranges from 24 to 56.6 with higher scores indicating greater physical health. The outcome is calculated as the difference in score at 12 weeks and the score at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 Weeks |
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|
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| Other Pre-specified | Change From Baseline SF-12 Aggregate Mental Score | The 12-Item Short-Form Health Survey (SF-12) is a validated survey which assesses overall physical and mental health. The Aggregate Mental Score ranges from 19.06 to 60.86 with higher scores indicating greater mental health. The outcome is calculated as the difference in score at 12 weeks and the score at baseline | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 Weeks |
|
|
|
| 1 |
| 111 |
| 4 |
| 111 |
| 72 |
| 111 |
| EG001 | Sham | Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device. | 0 | 55 | 2 | 55 | 30 | 55 |
| Colitis | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Death | General disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Chalazion | Eye disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Photopsia | Eye disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Anal paraesthesia | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Chapped lips | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Application site pain | General disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Application site paraesthesia | General disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Medical device site haemorrhage | General disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Medical device site pain | General disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Puncture site pain | General disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Multiple allergies | Immune system disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Eye infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Gastrointestinal viral infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Streptococcal infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
|
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA 17.1 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 17.1 | Non-systematic Assessment |
|
| Colonoscopy | Investigations | MedDRA 17.1 | Non-systematic Assessment |
|
| Endoscopy gastrointestinal | Investigations | MedDRA 17.1 | Non-systematic Assessment |
|
| Oesophagogastroduodenoscopy | Investigations | MedDRA 17.1 | Non-systematic Assessment |
|
| Gluten sensitivity | Metabolism and nutrition disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Diastasis recti abdominis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Cervical radiculopathy | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Nerve compression | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Urge incontinence | Renal and urinary disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Fibrocystic breast disease | Reproductive system and breast disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Vulvovaginal pain | Reproductive system and breast disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Sinus disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Abdominal hernia repair | Surgical and medical procedures | MedDRA 17.1 | Non-systematic Assessment |
|
| Abdominoplasty | Surgical and medical procedures | MedDRA 17.1 | Non-systematic Assessment |
|
| Medical device removal | Surgical and medical procedures | MedDRA 17.1 | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 17.1 | Non-systematic Assessment |
|
Not provided
Not provided
| Non-responder |
|
| Week 8 |
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| Week 12 |
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| Week 12 |
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| Week 12 |
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| Week 12 |
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| Week 12 |
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| Week 12 |
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| < 50% Improvement |
|
| Week 12 |
|
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| < 75% Improvement |
|
| Week 12 |
|
|
| No improvement |
|
| Week 8 |
|
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| Week 12 |
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| Week 12 |
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| Week 12 |
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| Week 12 |
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| Week 12 |
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| Week 12 |
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| Week 12 |
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| Week 12 |
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| Week 12 |
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| Control |
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| Week 4 |
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| Week 8 |
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| Week 12 |
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| Week 12 |
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| Week 12 |
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| Week 12 |
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| Week 12 |
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| Week 12 |
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| Week 12 |
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| Week 12 |
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| Week 12 |
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| Week 12 |
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| Week 12 |
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| Week 12 |
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| Week 12 |
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| Week 12 |
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| Week 12 |
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| Week 12 |
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| Week 12 |
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| Week 12 |
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| Week 12 |
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