Trial · NCT02176642

Comparison of Combination Therapy vs Single Agent Therapy for Treatment of Urge Incontinence.

NCT02176642, Phase 4, Terminated, Duke University; results first posted 2018-01-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Comparison of Combination Therapy vs Single Agent Therapy for Treatment of Urge Incontinence. Trials, record NCT02176642. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02176642

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Comparison of Combination Therapy vs Single Agent Therapy for Treatment of Urge Incontinence.
NCT number: NCT02176642
Status: Terminated
Phases: Phase 4
Enrollment: 55 participants, actual
Lead sponsor: Duke University
Conditions: Urinary Urge Incontinence
Interventions: Oxybutynin extended release, Posterior Tibial Nerve Stimulation, Placebo
First posted: 2014-06-27
Last updated: 2018-01-23
Results first posted: 2018-01-23

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Median Number of UUI Episodes Per Day	Baseline, 6 weeks	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 \[post-treatment UUI/day minus pre-treatment UUI/day\].
Secondary	Change in 24hr Pad Weight	Baseline, 6 weeks	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.
Other	Change in the Patient Global Impression of Improvement (PGI-I)	Baseline, 6 weeks	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).
Other	Change in the Overactive Bladder Questionnaire Short Form (OABq-SF) Part 1	Baseline, 6 weeks	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.
Other	Change in the Overactive Bladder Questionnaire Short Form (OABq-SF) Part 2	Baseline, 6 weeks	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.
Other	Change in the Urinary Distress Inventory (UDI-6)	Baseline, 6 weeks	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.
Other	Change in the Incontinence Impact Questionnaire (IIQ-7)	Baseline, 6 weeks	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.
Other	Change in Treatment Satisfaction Questionnaire for Medication, Version Two (TSQMvII) - Global Satisfaction Domain	Baseline, 6 weeks	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.
Other	Change in Treatment Satisfaction Questionnaire for Medication, Version Two (TSQMvII) - Side Effects Domain	Baseline, 6 weeks	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.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Median Number of UUI Episodes Per Day	Baseline, 6 weeks	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.	Urge urinary incontinence episodes/day	MEDIAN
SECONDARY	Change in 24hr Pad Weight	Baseline, 6 weeks	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.	grams	MEDIAN
OTHER_PRE_SPECIFIED	Change in the Patient Global Impression of Improvement (PGI-I)	Baseline, 6 weeks	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.	units on a scale	MEDIAN
OTHER_PRE_SPECIFIED	Change in the Overactive Bladder Questionnaire Short Form (OABq-SF) Part 1	Baseline, 6 weeks	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.	units on a scale	MEDIAN
OTHER_PRE_SPECIFIED	Change in the Overactive Bladder Questionnaire Short Form (OABq-SF) Part 2	Baseline, 6 weeks	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.	units on a scale	MEDIAN
OTHER_PRE_SPECIFIED	Change in the Urinary Distress Inventory (UDI-6)	Baseline, 6 weeks	1 patient in the oxybutynin+PTNS group did not complete the 6 week UDI-6 questionnaire so was not included in the analysis.	units on a scale	MEDIAN
OTHER_PRE_SPECIFIED	Change in the Incontinence Impact Questionnaire (IIQ-7)	Baseline, 6 weeks	1 patient in the oxybutynin+PTNS group did not complete the 6 week IIQ-7 questionnaire so was not included in the analysis.	units on a scale	MEDIAN
OTHER_PRE_SPECIFIED	Change in Treatment Satisfaction Questionnaire for Medication, Version Two (TSQMvII) - Global Satisfaction Domain	Baseline, 6 weeks	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.	units on a scale	MEDIAN
OTHER_PRE_SPECIFIED	Change in Treatment Satisfaction Questionnaire for Medication, Version Two (TSQMvII) - Side Effects Domain	Baseline, 6 weeks	Two patients in the placebo+PTN group did not complete the 6 week TSQMvII questionnaire so was not included in the analysis.	units on a scale	MEDIAN

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Median Number of UUI Episodes Per Day	Oxybutynin Plus PTNS	-0.3	Inter-Quartile Range -3.2 to 0.5	Urge urinary incontinence episodes/day
Change in Median Number of UUI Episodes Per Day	Placebo Plus PTNS	0.3	Inter-Quartile Range -1 to 1	Urge urinary incontinence episodes/day
Change in 24hr Pad Weight	Oxybutynin Plus PTNS	-52	Inter-Quartile Range -201.5 to -15.1	grams
Change in 24hr Pad Weight	Placebo Plus PTNS	-8	Inter-Quartile Range -103.5 to 13.5	grams
Change in the Patient Global Impression of Improvement (PGI-I)	Oxybutynin Plus PTNS	-1	Inter-Quartile Range -1 to 0	units on a scale
Change in the Patient Global Impression of Improvement (PGI-I)	Placebo Plus PTNS	-1	Inter-Quartile Range -1 to 0	units on a scale
Change in the Overactive Bladder Questionnaire Short Form (OABq-SF) Part 1	Oxybutynin Plus PTNS	-13.3	Inter-Quartile Range -25 to -5.1	units on a scale
Change in the Overactive Bladder Questionnaire Short Form (OABq-SF) Part 1	Placebo Plus PTNS	-10	Inter-Quartile Range -23.3 to 6.7	units on a scale
Change in the Overactive Bladder Questionnaire Short Form (OABq-SF) Part 2	Oxybutynin Plus PTNS	9.2	Inter-Quartile Range 6.5 to 18.1	units on a scale
Change in the Overactive Bladder Questionnaire Short Form (OABq-SF) Part 2	Placebo Plus PTNS	0	Inter-Quartile Range -7.7 to 11.6	units on a scale

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Oxybutynin Plus PTNS	18
Overall Study	STARTED	Placebo Plus PTNS	17
Overall Study	COMPLETED	Oxybutynin Plus PTNS	18
Overall Study	COMPLETED	Placebo Plus PTNS	16
Overall Study	NOT COMPLETED	Oxybutynin Plus PTNS	0
Overall Study	NOT COMPLETED	Placebo Plus PTNS	1

Source ClinicalTrials.gov

Adverse events6

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Skin Rash	Skin and subcutaneous tissue disorders	Oxybutynin Plus PTNS	0	18	0
other	Skin Rash	Skin and subcutaneous tissue disorders	Placebo Plus PTNS	1	16	1
other	Glaucoma	Eye disorders	Oxybutynin Plus PTNS	0	18	0
other	Glaucoma	Eye disorders	Placebo Plus PTNS	1	16	1
other	Possible cardiac symptons	Cardiac disorders	Oxybutynin Plus PTNS	0	18	0
other	Possible cardiac symptons	Cardiac disorders	Placebo Plus PTNS	1	16	1

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Oxybutynin Plus PTNS	0	18
Total, all-cause mortality	Placebo Plus PTNS	0	16
Total, other adverse events	Oxybutynin Plus PTNS	0	18
Total, other adverse events	Placebo Plus PTNS	3	16
Total, serious adverse events	Oxybutynin Plus PTNS	0	18
Total, serious adverse events	Placebo Plus PTNS	0	16

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Oxybutynin Plus PTNS vs Placebo Plus PTNS: deaths from any cause	Trial comparisons
Oxybutynin Plus PTNS vs Placebo Plus PTNS: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

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The record and each of its lists are JSON, twenty rows a page. No key.

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