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The purpose of this study is to demonstrate that the TOPAS System effectively treats fecal incontinence in women as measured by a 50% reduction in the number of FI episodes in a 14 day bowel diary at 12 months.
This is a prospective, multi-center, single-arm, open-label, two- stage, adaptive study conducted to obtain data to demonstrate the safety and effectiveness of the TOPAS system for the treatment of FI in women who have failed conservative therapy. It was approved by the FDA for up to 152 implanted subjects at up to 15 investigational sites in the US. Eight study centers are led by a Colorectal Surgeon and seven centers are led by an Urogynecologist.
This study is being conducted in compliance with Title 21 CFR Parts 11, 50, 54, 56, and 812; the principles of GCP as set forth in the World Medical Association Declaration of Helsinki (2008); and the ISO standard 14155:2011 (Clinical investigation of medical devices for human subjects - Good clinical practice).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TOPAS | Experimental | TOPAS Treatment for Fecal Incontinence |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TOPAS Treatment for Fecal Incontinence | Device | The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Responders | The primary endpoint for efficacy is the 14 day bowel diary documenting liquid or solid fecal incontinence episodes. A 50% reduction in the number of FI episodes is considered a treatment responder. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fecal Incontinence Episodes | Number of fecal incontinence episodes in a 14 day period | 36 Month Follow-up Visit |
| Change in Fecal Incontinence Days | Number of fecal incontinence days in a 14 day period |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Haff Surgical Satisfaction Questionnaire (SSQ-8) | The SSQ-8 is an 8 item questionnaire to assess subject surgical satisfaction as described by Murphy M, Sternschuss G, Haff R, van Raalte H, Saltz S, Lucente V. Quality of life and surgical satisfaction after vaginal reconstructive vs. obliterative surgery for the treatment of advanced pelvic organ prolapse. Am J Obstet Gynecol. 2008 May;198(5):573.e1-7. The SSQ-8 was collected as an optional one-time assessment from implanted subjects between the 3 and 36 month visits. Scale is scored on 0-100 with higher scores are better |
Inclusion Criteria:
Subject is/has:
Exclusion Criteria:
Subject is/has
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| Name | Affiliation | Role |
|---|---|---|
| Anders Mellgren, MD, PhD | University of Illinois at Chicago | Study Chair |
| Dee Fenner, MD | University of Michigan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California SF - Mt Zion Medical Center | San Francisco | California | 94115 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26493933 | Result | Mellgren A, Zutshi M, Lucente VR, Culligan P, Fenner DE; TOPAS Study Group. A posterior anal sling for fecal incontinence: results of a 152-patient prospective multicenter study. Am J Obstet Gynecol. 2016 Mar;214(3):349.e1-8. doi: 10.1016/j.ajog.2015.10.013. Epub 2015 Oct 19. |
| Label | URL |
|---|---|
| Primary (1 Year) Results Manuscript | View source |
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Each site was provided with their individual participant data
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Following enrollment (i.e., signing informed consent form), subjects underwent two screening visits to evaluate and confirm eligibility for the TOPAS implant procedures.
Subject recruitment occurred from July 2010 - December 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | TOPAS | TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Enrollment |
|
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|
| 36 Month Follow-up Visit |
| Change in Urge Fecal Incontinence Episodes | Number of urge fecal incontinence episodes in a 14 day period | 36 Month Follow-up Visit |
| Change in Wexner Symptom Severity Score | Wexner Symptom Severity Score for fecal incontinence (also known as the Cleveland Clinic Incontinence Score) as described by Jorge and Wexner, 1993 (Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97). Measured on a 0-20 scale with lower scores equal to less fecal incontinence. | 36 Month Follow-up Visit |
| Change in Fecal Incontinence Quality of Life Score | Fecal Incontinence Quality of Life Score as described by Rockwood et al., 2000 (Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000 Jan;43(1):9-16; discussion 16-7). Four domains of lifestyle, coping, depression, and embarrassment. Measured on a 0-4 scale with higher scores equal to better quality of life. | 36 Month Follow-up Visit |
| Change in Pelvic Floor Distress Inventory (PFDI-20) Scores | Short-form version of the Pelvic Floor Distress Inventory (PFDI-20) as described by Barber et al., 2005 (Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7. Am J Obstet Gynecol. 2005 Jul;193(1):103-13). The short-form version of the Pelvic Floor Distress Inventory has a total of 20 questions and 3 scales (Urinary Distress Inventory, Pelvic Organ Prolapse Distress Inventory, and Colorectal-Anal Distress Inventory). Total PFDI score measured on a 0-300 scale with higher scores equal to greater pelvic floor distress. As with the Total PFDI Score, higher subscale scores equal greater pelvic floor distress, on a 0-100 scale. | 36 Month Follow-up Visit |
| Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores | Short-form version of the Pelvic Floor Impact Questionnaire (PFIQ-7) as described by Barber et al., 2005 (Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7. Am J Obstet Gynecol. 2005 Jul;193(1):103-13). The short-form version of the Pelvic Floor Impact Questionnaire has a total of 7 questions and 3 scales (Urinary Impact, Pelvic Organ Prolapse Impact, and Colorectal-Anal Impact). Total PFIQ score measured on a 0-300 scale with higher scores equal to greater pelvic floor impact. Subscales scored on 0-100 scale and the higher the score the greater pelvic floor impact, exactly like the Total PFIQ score. | 36 Month Follow-up Visit |
| Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) | Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) as described by Rogers RG, Coates KW, Kammerer-Doak D, Khalsa S, Qualls C. A short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Int Urogynecol J Pelvic Floor Dysfunct. 2003 Aug;14(3):164-8; discussion 168. Measured on a 0-48 scale with higher scores equal to better sexual function. | 36 Month Follow-up Visit |
| Change in Numeric Pelvic Pain Scale (NPPS) | Numeric Pelvic Pain Scale (NPPS) adapted from McCafferty M, Pasero C. Pain: Clinical Manual. 2nd ed. Philadelphia: Mosby Inc.; 1999. Chapter 3, Assessment Tools; p. 58-75. The NPPS is scored on a 0-10 scale with higher scores indicating more severe pain. Since the NPPS was introduced later in the study, earlier implanted subjects did not have the baseline NPPS score and a change from baseline could not be calculated. | 12 Month Follow-up Visit |
| 36 Month Follow-up Visit |
| Change in Health Resource Usage: # Pads Per Day Subject Took for FI | Change in health resource usage using sponsor-created questionnaire: # days in hospital due to FI | 36 Month Follow-up Visit |
| Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI | Change in health resource usage using sponsor-created questionnaire | 36 Month Follow-up Visit |
| Change in Health Resource Usage: # Physician Visits Due to FI | Change in health resource usage using sponsor-created questionnaire | 36 Month Follow-up Visit |
| University of South Florida |
| Tampa |
| Florida |
| 33605 |
| United States |
| Cleveland Clinic Foundation - Florida | Weston | Florida | 33331 | United States |
| Raybon OB-GYN | Toccoa | Georgia | 30577 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Atlantic Health System | Morristown | New Jersey | 07960 | United States |
| University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Cleveland Clinic Foundation - Ohio | Cleveland | Ohio | 44195 | United States |
| University of Oklahoma | Oklahoma City | Oklahoma | 76104 | United States |
| St. Luke's Hospital | Allentown | Pennsylvania | 18104 | United States |
| Womens Hospital of Texas | Houston | Texas | 77054 | United States |
| Sacred Heart Medical Center | Spokane | Washington | 99204 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
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| 12 Month Follow-up |
|
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| 24 Month Follow-up |
|
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| 36 Month Follow-up |
|
|
All subjects who met the study inclusion/exclusion criteria and were implanted with the TOPAS device.
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| ID | Title | Description |
|---|---|---|
| BG000 | TOPAS | TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex/Gender, Customized | Number | participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Obstetric History - Gravidity | Number of times subjects have been pregnant | Mean | Standard Deviation | number |
| |||||||||||||||||||||
| Obstetric History - Parity | Parity is defined as the number of pregnancies carried to gestation | Mean | Standard Deviation | number |
| |||||||||||||||||||||
| Obstetric History - # of Vaginal Deliveries | The number of times a women delivered vaginally | Mean | Standard Deviation | number |
| |||||||||||||||||||||
| Obstetric History - # of Caesarean deliveries | women delivering via a caesarean procedure | Mean | Standard Deviation | number |
| |||||||||||||||||||||
| Menopausal Status | Number | participants |
| |||||||||||||||||||||||
| Concomitant Use | Number | participants |
| |||||||||||||||||||||||
| Duration of Fecal Incontinence | Mean | Standard Deviation | months |
| ||||||||||||||||||||||
| Etiology of Fecal Incontinence | Subjects can have multiple etiologies so total does not equal 152 (number of subjects) | Number | participants |
| ||||||||||||||||||||||
| Rectal soft tissue scarring | Number | participants |
| |||||||||||||||||||||||
| Baseline Medical History | Subjects can have multiple medical history items so the total does not equal 152 (number of subjects). | Number | participants |
| ||||||||||||||||||||||
| Baseline Fecal Incontinence Medication | Subjects taking medications does not equal 152 (number of subjects). | Number | participants |
| ||||||||||||||||||||||
| Failed Fecal Incontinence Conservative Therapy | Subjects had to fail at least two conservative therapies for their FI prior to entry into the study. | Number | participants |
| ||||||||||||||||||||||
| Hemorrhoids | Number | participants |
| |||||||||||||||||||||||
| Anal Resting Tone | Number | participants |
| |||||||||||||||||||||||
| Anorectal Manometry - Pressures | Mean | Standard Deviation | mmHg |
| ||||||||||||||||||||||
| Anorectal Manometry - Volumes | Mean | Standard Deviation | cc |
| ||||||||||||||||||||||
| External Anal Sphincter Defects | Number | participants |
| |||||||||||||||||||||||
| Internal Anal Sphincter Defects | Number | participants |
| |||||||||||||||||||||||
| External Anal Sphincter Defect Extent | Mean | Standard Deviation | degrees |
| ||||||||||||||||||||||
| Internal Anal Sphincter Defect Extent | Mean | Standard Deviation | degrees |
|
| 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 | Percentage of Responders | The primary endpoint for efficacy is the 14 day bowel diary documenting liquid or solid fecal incontinence episodes. A 50% reduction in the number of FI episodes is considered a treatment responder. | All subjects implanted | Posted | Number | 95% Confidence Interval | percentage of treatment responders | 12 Months |
|
|
| |||||||||||||||||||||||||
| Secondary | Change in Fecal Incontinence Episodes | Number of fecal incontinence episodes in a 14 day period | All subjects implanted | Posted | Median | Full Range | fecal incontinent episodes/14 days | 36 Month Follow-up Visit |
|
| ||||||||||||||||||||||||||
| Secondary | Change in Fecal Incontinence Days | Number of fecal incontinence days in a 14 day period | All subjects implanted | Posted | Median | Full Range | fecal incontinent days/14 days | 36 Month Follow-up Visit |
|
| ||||||||||||||||||||||||||
| Secondary | Change in Urge Fecal Incontinence Episodes | Number of urge fecal incontinence episodes in a 14 day period | All subjects implanted | Posted | Median | Full Range | urge fecal incontinent episodes/14 days | 36 Month Follow-up Visit |
|
| ||||||||||||||||||||||||||
| Secondary | Change in Wexner Symptom Severity Score | Wexner Symptom Severity Score for fecal incontinence (also known as the Cleveland Clinic Incontinence Score) as described by Jorge and Wexner, 1993 (Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97). Measured on a 0-20 scale with lower scores equal to less fecal incontinence. | All subjects implanted | Posted | Mean | Standard Deviation | units on a scale | 36 Month Follow-up Visit |
|
| ||||||||||||||||||||||||||
| Secondary | Change in Fecal Incontinence Quality of Life Score | Fecal Incontinence Quality of Life Score as described by Rockwood et al., 2000 (Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000 Jan;43(1):9-16; discussion 16-7). Four domains of lifestyle, coping, depression, and embarrassment. Measured on a 0-4 scale with higher scores equal to better quality of life. | All subjects implanted | Posted | Mean | Standard Deviation | units on a scale | 36 Month Follow-up Visit |
|
| ||||||||||||||||||||||||||
| Secondary | Change in Pelvic Floor Distress Inventory (PFDI-20) Scores | Short-form version of the Pelvic Floor Distress Inventory (PFDI-20) as described by Barber et al., 2005 (Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7. Am J Obstet Gynecol. 2005 Jul;193(1):103-13). The short-form version of the Pelvic Floor Distress Inventory has a total of 20 questions and 3 scales (Urinary Distress Inventory, Pelvic Organ Prolapse Distress Inventory, and Colorectal-Anal Distress Inventory). Total PFDI score measured on a 0-300 scale with higher scores equal to greater pelvic floor distress. As with the Total PFDI Score, higher subscale scores equal greater pelvic floor distress, on a 0-100 scale. | All subjects implanted | Posted | Mean | Standard Deviation | units on a scale | 36 Month Follow-up Visit |
|
| ||||||||||||||||||||||||||
| Secondary | Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores | Short-form version of the Pelvic Floor Impact Questionnaire (PFIQ-7) as described by Barber et al., 2005 (Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7. Am J Obstet Gynecol. 2005 Jul;193(1):103-13). The short-form version of the Pelvic Floor Impact Questionnaire has a total of 7 questions and 3 scales (Urinary Impact, Pelvic Organ Prolapse Impact, and Colorectal-Anal Impact). Total PFIQ score measured on a 0-300 scale with higher scores equal to greater pelvic floor impact. Subscales scored on 0-100 scale and the higher the score the greater pelvic floor impact, exactly like the Total PFIQ score. | All subjects implanted | Posted | Mean | Standard Deviation | units on a scale | 36 Month Follow-up Visit |
|
| ||||||||||||||||||||||||||
| Secondary | Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) | Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) as described by Rogers RG, Coates KW, Kammerer-Doak D, Khalsa S, Qualls C. A short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Int Urogynecol J Pelvic Floor Dysfunct. 2003 Aug;14(3):164-8; discussion 168. Measured on a 0-48 scale with higher scores equal to better sexual function. | All subjects implanted | Posted | Mean | Standard Deviation | units on a scale | 36 Month Follow-up Visit |
|
| ||||||||||||||||||||||||||
| Secondary | Change in Numeric Pelvic Pain Scale (NPPS) | Numeric Pelvic Pain Scale (NPPS) adapted from McCafferty M, Pasero C. Pain: Clinical Manual. 2nd ed. Philadelphia: Mosby Inc.; 1999. Chapter 3, Assessment Tools; p. 58-75. The NPPS is scored on a 0-10 scale with higher scores indicating more severe pain. Since the NPPS was introduced later in the study, earlier implanted subjects did not have the baseline NPPS score and a change from baseline could not be calculated. | All subjects implanted at the time the NPPS was implemented in the study | Posted | Mean | Standard Deviation | units on a scale | 12 Month Follow-up Visit |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Change in the Haff Surgical Satisfaction Questionnaire (SSQ-8) | The SSQ-8 is an 8 item questionnaire to assess subject surgical satisfaction as described by Murphy M, Sternschuss G, Haff R, van Raalte H, Saltz S, Lucente V. Quality of life and surgical satisfaction after vaginal reconstructive vs. obliterative surgery for the treatment of advanced pelvic organ prolapse. Am J Obstet Gynecol. 2008 May;198(5):573.e1-7. The SSQ-8 was collected as an optional one-time assessment from implanted subjects between the 3 and 36 month visits. Scale is scored on 0-100 with higher scores are better | All implanted subjects | Posted | Mean | Standard Deviation | units on a scale | 36 Month Follow-up Visit |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Change in Health Resource Usage: # Pads Per Day Subject Took for FI | Change in health resource usage using sponsor-created questionnaire: # days in hospital due to FI | All implanted subjects | Posted | Mean | Standard Deviation | pads per day | 36 Month Follow-up Visit |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI | Change in health resource usage using sponsor-created questionnaire | All implanted subjects | Posted | Mean | Standard Deviation | days | 36 Month Follow-up Visit |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Change in Health Resource Usage: # Physician Visits Due to FI | Change in health resource usage using sponsor-created questionnaire | All implanted subjects | Posted | Mean | Standard Deviation | physician visits | 36 Month Follow-up Visit |
|
|
AEs collected for each subject from the time of enrollment (signing informed consent form) through duration of follow-up visits (up to 60 months). The mean follow-up period for all subjects was 40.2 months (509 subject years).
An independent Adverse Event Adjudication Committee (three physicians: Colorectal, Gastroenterology, Urogynecology) reviewed all AEs and death data and assigned or verified correct assignment of codes, event seriousness, relatedness to the study device and/or procedure. All AEs listed here are device- and/or procedure-related only.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TOPAS | TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh. | 8 | 152 | 72 | 152 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain/discomfort - buttock | Musculoskeletal and connective tissue disorders | Systematic Assessment | Exacerbation of sciatic pain |
| |
| Worsening Pelvic Organ Prolapse | Reproductive system and breast disorders | Systematic Assessment | Recurrent rectal prolapse |
| |
| De novo pelvic organ prolapse | Reproductive system and breast disorders | Systematic Assessment | Mild cystocele / enterocele / rectocele |
| |
| Exacerbated post traumatic stress disorder | Psychiatric disorders | Systematic Assessment |
| ||
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Worsening chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| De novo rectal prolapse | Reproductive system and breast disorders | Systematic Assessment | Mucosal prolapse |
| |
| Methicillin-resistant staphylococcus aureus infection | Infections and infestations | Systematic Assessment | Hospital acquired - Left hand |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pelvic area pain | Reproductive system and breast disorders | Systematic Assessment | Pain/discomfort in the general pelvic region including the buttocks, groin, pelvis, upper leg, urogenitals and abdomen. |
| |
| Infection | Infections and infestations | Systematic Assessment | Includes incision site infection, abscess, UTIs, and fungal infections |
| |
| Urinary problems | Renal and urinary disorders | Systematic Assessment | Includes de novo and worsening urinary incontinence and retention |
| |
| Pelvic organ prolapse | Reproductive system and breast disorders | Systematic Assessment | Includes de novo and worsening vaginal and rectal prolapse |
| |
| Bleeding | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Defecatory problems | Gastrointestinal disorders | Systematic Assessment | includes worsening fecal incontinence and constipation |
| |
| Other | Injury, poisoning and procedural complications | Systematic Assessment | Includes Allergic Reaction / Hypersensitivity Reaction, Diarrhea, Headache, Deep Venous Thrombosis, COPD, Nausea, Post-Traumatic Stress Disorder, Rectal Discharge, Skin Irritation, and Wound Dehiscence |
|
Study was a single arm trial with no control group. Study was done with a very specialized group of clinical investigators from two medical sub-specialties, Colorectal Surgeons and Urogynecologists. Study population was primarily Caucasian (90%).
After the primary or the combined data article has been published, an Investigator may publish the study experience from his/her site. However, the Sponsor reserves the right to review the manuscript prior to submission in order to verify accuracy of the data.
All publications will be reviewed by the sponsor in order to assure that no confidential information is disclosed. Such confidential information is not allowed for publishing.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dee Fenner, MD, Study Coordinating Investigator | University of Michigan, Professor of Obstetrics and Gynecology | 734-647-5866 | deef@med.umich.edu |
| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Death |
|
| Asian |
|
| Hispanic/Latina |
|
| Other |
|
| Post-menopausal |
|
| # Rgular laxative use within past 5 years |
|
| Idiopathic/unknown |
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| Other |
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| Gastrointestional reflux disease |
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| Hypertension |
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| Depressive disorder |
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| Systemic pain |
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| Hyperlipidemia |
|
| Pelvic area pain |
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| Diverticulitis |
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| Urinary incontinence |
|
| Hypothroid |
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| Previous cholecystectomy |
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| Hemorrhoids |
|
| Irritable bowel syndrome |
|
| Previous anal sphincter repair |
|
| Headaches |
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| Vaginal atrophy |
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| Diabetes |
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| Vaginal prolapse |
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| Rectal prolapse |
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| Gallstones |
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| Osmotic laxatives |
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| Anti-cholinergic agents |
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| Other meds |
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| Bile acid sequestrants |
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| Medication and pelvic floor muscle training |
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| Diet, medication and pelvic floor training |
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