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| Name | Class |
|---|---|
| Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction | OTHER |
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This is a randomized double-blind placebo-controlled clinical trial of posterior tibial nerve stimulation (PTNS) plus extended release oxybutynin versus PTNS alone (placebo pills) in women undergoing treatment of urgency urinary incontinence (UUI).
The investigators hypothesize that combination therapy with PTNS and anticholinergic medication will result in a significant incremental improvement in UUI symptoms over that achieved with PTNS alone. In addition, the investigators hypothesize that the addition of anticholinergics to PTNS will result in a greater improvement in patients' perception of treatment response, symptom distress, and quality of life than PTNS alone.
Specific Aim 1: To compare the change, from baseline, in mean number of UUI episodes per day using a 3-day bladder diary between PTNS plus anticholinergic medication versus PTNS plus placebo in women undergoing treatment for UUI.
Specific Aim 2: To compare the change, from baseline, in a 24hr pad weight between PTNS plus anticholinergic medication versus PTNS plus placebo.
Specific Aim 3: To compare subjective treatment response, symptoms distress, and quality of life between PTNS plus anticholinergic medication versus PTNS plus placebo utilizing the Patient Global Impression of Improvement (PGI-I) and the Overactive Bladder Questionnaire Short Form (OABq-SF).
An interim analysis will be conducted by an independent entity after 50 participants have completed the study protocol. A Data Safety Monitoring Board is not utilized because the study utilizes FDA approved treatments for urgency urinary incontinence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxybutynin plus PTNS | Active Comparator | Oxybutynin extended release (blinded tablet) 5mg by mouth daily for 6 weeks, Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. |
|
| Placebo plus PTNS | Placebo Comparator | Placebo (blinded tablet) taken daily for 6 weeks. Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxybutynin extended release | Drug | 5mg tablet taken by mouth daily for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Median Number of UUI Episodes Per Day | To compare the change, from baseline, in median number of UUI episodes per day using a 3-day bladder diary between PTNS plus anticholinergic medication versus PTNS plus placebo in women undergoing treatment for UUI. UUI change score will be calculated [post-treatment UUI/day minus pre-treatment UUI/day]. | Baseline, 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24hr Pad Weight | To compare the change, from baseline, in 24h pad weight between PTNS plus anticholinergic medication versus PTNS plus placebo. Change in median 24h pad weight from baseline to 6 weeks was compared between the 2 groups using Wilcoxon Rank Sum test. | Baseline, 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Patient Global Impression of Improvement (PGI-I) | The Patient Global Impression of Improvement (PGI-I) is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 (Very much better to) 7 (Very much worse). | Baseline, 6 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nazema Y Siddiqui, MD, MHS | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Urogynecology | Durham | North Carolina | 27707 | United States | ||
| Duke OB/GYN Consultants of Raleigh |
A total of 104 patients were assessed for eligibility. Forty-nine patients declined or were deemed ineligible. Fifty-five patients consented to participate but 20 dropped out before randomization. Therefore, a total of 35 patients were randomized as noted in the boxes below (18 in the active medication group, 17 in the placebo group).
Potential participants were identified, recruited, and enrolled at the time of their outpatient clinic visits with the Duke Urogynecology clinic. All women who were considering therapy with posterior tibial nerve stimulation were approached for participation in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxybutynin Plus PTNS | Oxybutynin extended release (blinded tablet) 5mg by mouth daily for 6 weeks, Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. Oxybutynin extended release: 5mg tablet taken by mouth daily for 6 weeks Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks |
| FG001 | Placebo Plus PTNS | Placebo (blinded tablet) taken daily for 6 weeks. Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks Placebo: Tablet taken by mouth daily for 6 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All subjects who started treatment were included in analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxybutynin Plus PTNS | Oxybutynin extended release (blinded tablet) 5mg by mouth daily for 6 weeks, Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. Oxybutynin extended release: 5mg tablet taken by mouth daily for 6 weeks Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks |
| 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 in Median Number of UUI Episodes Per Day | To compare the change, from baseline, in median number of UUI episodes per day using a 3-day bladder diary between PTNS plus anticholinergic medication versus PTNS plus placebo in women undergoing treatment for UUI. UUI change score will be calculated [post-treatment UUI/day minus pre-treatment UUI/day]. | 3 patients in each group did not provide bladder diaries at their 6 week visit, so did not have information available to calculate the primary outcome measure. Median change in UUI episodes/day from baseline to 6 weeks was compared between 2 groups using Wilcoxon Rank Sum test. | Posted | Median | Inter-Quartile Range | Urge urinary incontinence episodes/day | Baseline, 6 weeks |
|
Baseline to 6 weeks
We systematically assessed for adverse events related to either PTNS or medication/placebo on a weekly basis. Any adverse events related to PTNS were documented on the patients weekly treatment note for the clinic encounter. Any adverse events related to study medication or placebo were documented via the TSQMvII questionnaire that subjects completed on a weekly basis during treatment.
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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 | Oxybutynin Plus PTNS | Oxybutynin extended release (blinded tablet) 5mg by mouth daily for 6 weeks, Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. Oxybutynin extended release: 5mg tablet taken by mouth daily for 6 weeks Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nazema Siddiqui MD | Duke University | nazema.siddiqui@duke.edu |
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| ID | Term |
|---|---|
| D053202 | Urinary Incontinence, Urge |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000068737 | Tolterodine Tartrate |
| ID | Term |
|---|---|
| D010665 | Phenylpropanolamine |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| Posterior Tibial Nerve Stimulation | Device | In office therapy administered for 30 minutes once every week for a total of 6 weeks |
|
|
| Placebo | Drug | Tablet taken by mouth daily for 6 weeks |
|
|
| Change in the Overactive Bladder Questionnaire Short Form (OABq-SF) Part 1 | Part 1 of the OABq-SF questionnaire asks about the relative bother a patient experiences with regard to overactive bladder symptoms over the previous 4 weeks. This part of the questionnaire has 6 questions, with scores ranging from 6 (least amount of bother) to 36 (most amount of bother). For this secondary outcome, we are measuring the change in score on the OABq-SF Part 1 from baseline to 6 weeks. Median change in scores were compared between the 2 groups using Wilcoxon Rank Sum test. | Baseline, 6 weeks |
| Change in the Overactive Bladder Questionnaire Short Form (OABq-SF) Part 2 | Part 2 of the OABq-SF questionnaire asks about the relative bother a patient experiences with regard to overactive bladder symptoms over the previous 4 weeks. This part of the questionnaire has 13 questions, with scores ranging from 13 (least amount of bother) to 78 (most amount of bother). For this secondary outcome, we are measuring the change in score on the OABq-SF Part 2 from baseline to 6 weeks. Median change in scores were compared between the 2 groups using Wilcoxon Rank Sum test. | Baseline, 6 weeks |
| Change in the Urinary Distress Inventory (UDI-6) | The UDI-6 is a 6-question inventory of how frequently and how much bother patients have from overactive bladder symptoms. The scores range from 0 (not at all) to 24 (a great deal of bother). We compared the change in scores from baseline to 6 weeks between the 2 groups using Wilcoxon Rank Sum test. | Baseline, 6 weeks |
| Change in the Incontinence Impact Questionnaire (IIQ-7) | The IIQ-7 is a 7-question score assessing how urinary incontinence affects a patient's various activities and feelings. The range of possible scores is from 0 (not at all) to 28 (a great deal). Median change in scores from baseline to 6 weeks were compared between the 2 groups using Wilcoxon Rank Sum test. | Baseline, 6 weeks |
| Change in Treatment Satisfaction Questionnaire for Medication, Version Two (TSQMvII) - Global Satisfaction Domain | To compare treatment satisfaction between PTNS plus anticholinergic medication versus PTNS plus placebo using the Treatment Satisfaction Questionnaire for Medication, version two (TSQMvII). Patients completed the questionnaire at baseline and again at 6 weeks. The TSQMvII satisfaction domains at each timepjoint were transformed into a score from 0 (extremely dissatisfied) to 100 (extremely satisfied). Median change in scores from baseline to 6 weeks were compared between the 2 groups using Wilcoxon Rank Sum Test. | Baseline, 6 weeks |
| Change in Treatment Satisfaction Questionnaire for Medication, Version Two (TSQMvII) - Side Effects Domain | To compare bother from medication side effects between PTNS plus anticholinergic medication versus PTNS plus placebo using the Treatment Satisfaction Questionnaire for Medication, version two (TSQMvII). The questionnaire was completed at baseline and at 6 weeks. The TSQMvII side effects domain at each time point was transformed into a score from 0 (extremely dissatisfied) to 150 (extremely satisfied). Median change in scores from baseline to 6 weeks were compared between the 2 groups using Wilcoxon Rank Sum Test. | Baseline, 6 weeks |
| Raleigh |
| North Carolina |
| 27607 |
| United States |
| BG001 | Placebo Plus PTNS | Placebo (blinded tablet) taken daily for 6 weeks. Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks Placebo: Tablet taken by mouth daily for 6 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Placebo Plus PTNS | Placebo (blinded tablet) taken daily for 6 weeks. Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks Placebo: Tablet taken by mouth daily for 6 weeks |
|
|
|
| Secondary | Change in 24hr Pad Weight | To compare the change, from baseline, in 24h pad weight between PTNS plus anticholinergic medication versus PTNS plus placebo. Change in median 24h pad weight from baseline to 6 weeks was compared between the 2 groups using Wilcoxon Rank Sum test. | Six participants in the placebo+PNTS group and 3 patients in the oxybutynin+PTNS group did not provide a pad weight at the end of the study, and thus were unable to have the pad weight change score calculated. | Posted | Median | Inter-Quartile Range | grams | Baseline, 6 weeks |
|
|
|
|
| Other Pre-specified | Change in the Patient Global Impression of Improvement (PGI-I) | The Patient Global Impression of Improvement (PGI-I) is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 (Very much better to) 7 (Very much worse). | 2 patients in the oxybutynin+PTNS group and one patient in the placebo+PTNS group did not complete the 6 week PGI-I questionnaire so they were not included in the analysis. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline, 6 weeks |
|
|
|
|
| Other Pre-specified | Change in the Overactive Bladder Questionnaire Short Form (OABq-SF) Part 1 | Part 1 of the OABq-SF questionnaire asks about the relative bother a patient experiences with regard to overactive bladder symptoms over the previous 4 weeks. This part of the questionnaire has 6 questions, with scores ranging from 6 (least amount of bother) to 36 (most amount of bother). For this secondary outcome, we are measuring the change in score on the OABq-SF Part 1 from baseline to 6 weeks. Median change in scores were compared between the 2 groups using Wilcoxon Rank Sum test. | 3 patients in the oxybutynin+PTNS group did not submit their OABq-SF at the end of the study, so they were unable to be included in the analysis. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline, 6 weeks |
|
|
|
|
| Other Pre-specified | Change in the Overactive Bladder Questionnaire Short Form (OABq-SF) Part 2 | Part 2 of the OABq-SF questionnaire asks about the relative bother a patient experiences with regard to overactive bladder symptoms over the previous 4 weeks. This part of the questionnaire has 13 questions, with scores ranging from 13 (least amount of bother) to 78 (most amount of bother). For this secondary outcome, we are measuring the change in score on the OABq-SF Part 2 from baseline to 6 weeks. Median change in scores were compared between the 2 groups using Wilcoxon Rank Sum test. | Four patients in the oxybutynin+PTNS group and 1 patient in the placebo+PTNS did not submit their OABq-SF part 2 at the end of the study, so they were unable to be included in the analysis. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline, 6 weeks |
|
|
|
|
| Other Pre-specified | Change in the Urinary Distress Inventory (UDI-6) | The UDI-6 is a 6-question inventory of how frequently and how much bother patients have from overactive bladder symptoms. The scores range from 0 (not at all) to 24 (a great deal of bother). We compared the change in scores from baseline to 6 weeks between the 2 groups using Wilcoxon Rank Sum test. | 1 patient in the oxybutynin+PTNS group did not complete the 6 week UDI-6 questionnaire so was not included in the analysis. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline, 6 weeks |
|
|
|
|
| Other Pre-specified | Change in the Incontinence Impact Questionnaire (IIQ-7) | The IIQ-7 is a 7-question score assessing how urinary incontinence affects a patient's various activities and feelings. The range of possible scores is from 0 (not at all) to 28 (a great deal). Median change in scores from baseline to 6 weeks were compared between the 2 groups using Wilcoxon Rank Sum test. | 1 patient in the oxybutynin+PTNS group did not complete the 6 week IIQ-7 questionnaire so was not included in the analysis. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline, 6 weeks |
|
|
|
|
| Other Pre-specified | Change in Treatment Satisfaction Questionnaire for Medication, Version Two (TSQMvII) - Global Satisfaction Domain | To compare treatment satisfaction between PTNS plus anticholinergic medication versus PTNS plus placebo using the Treatment Satisfaction Questionnaire for Medication, version two (TSQMvII). Patients completed the questionnaire at baseline and again at 6 weeks. The TSQMvII satisfaction domains at each timepjoint were transformed into a score from 0 (extremely dissatisfied) to 100 (extremely satisfied). Median change in scores from baseline to 6 weeks were compared between the 2 groups using Wilcoxon Rank Sum Test. | Two patients in the placebo+PTN group and 1 patient in the oxybutynin+PTNS group did not complete the 6 week TSQMvII questionnaire so was not included in the analysis. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline, 6 weeks |
|
|
|
|
| Other Pre-specified | Change in Treatment Satisfaction Questionnaire for Medication, Version Two (TSQMvII) - Side Effects Domain | To compare bother from medication side effects between PTNS plus anticholinergic medication versus PTNS plus placebo using the Treatment Satisfaction Questionnaire for Medication, version two (TSQMvII). The questionnaire was completed at baseline and at 6 weeks. The TSQMvII side effects domain at each time point was transformed into a score from 0 (extremely dissatisfied) to 150 (extremely satisfied). Median change in scores from baseline to 6 weeks were compared between the 2 groups using Wilcoxon Rank Sum Test. | Two patients in the placebo+PTN group did not complete the 6 week TSQMvII questionnaire so was not included in the analysis. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline, 6 weeks |
|
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Placebo Plus PTNS | Placebo (blinded tablet) taken daily for 6 weeks. Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. Posterior Tibial Nerve Stimulation: In office therapy administered for 30 minutes once every week for a total of 6 weeks Placebo: Tablet taken by mouth daily for 6 weeks | 0 | 16 | 0 | 16 | 3 | 16 |
| Glaucoma | Eye disorders | Systematic Assessment |
|
| Possible cardiac symptons | Cardiac disorders | Systematic Assessment | chest pain, shortness of breath, headache |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D003408 | Cresols |
| D010636 | Phenols |