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

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ClinicalTrials.gov Identifier: NCT02176642
Recruitment Status : Terminated
First Posted : June 27, 2014
Results First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
Society of Urodynamics and Female Pelvic Medicine & Urogenital Reconstruction
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Urinary Urge Incontinence
Interventions Drug: Oxybutynin extended release
Device: Posterior Tibial Nerve Stimulation
Drug: Placebo
Enrollment 55
Recruitment Details 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.
Pre-assignment Details 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).
Arm/Group Title Oxybutynin Plus PTNS Placebo Plus PTNS
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 18 17
Completed 18 16
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Arm/Group Title Oxybutynin Plus PTNS Placebo Plus PTNS Total
Hide Arm/Group Description

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

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

Total of all reporting groups
Overall Number of Baseline Participants 18 16 34
Hide Baseline Analysis Population Description
All subjects who started treatment were included in analysis
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 16 participants 34 participants
72.7  (9.8) 70.4  (8.5) 71.6  (9.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 34 participants
Female
18
 100.0%
16
 100.0%
34
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 34 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
18
 100.0%
16
 100.0%
34
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 34 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  16.7%
3
  18.8%
6
  17.6%
White
15
  83.3%
13
  81.3%
28
  82.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 18 participants 16 participants 34 participants
18
 100.0%
16
 100.0%
34
 100.0%
1.Primary Outcome
Title Change in Median Number of UUI Episodes Per Day
Hide Description 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].
Time Frame Baseline, 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Oxybutynin Plus PTNS Placebo Plus PTNS
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 15 13
Median (Inter-Quartile Range)
Unit of Measure: Urge urinary incontinence episodes/day
-0.3
(-3.2 to 0.5)
0.3
(-1 to 1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oxybutynin Plus PTNS, Placebo Plus PTNS
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments We estimated that women in the placebo group would have mean reduction of 3 UUI episodes per day. Assuming 50% improvement in UUI episodes per day is a clinically significant improvement, we estimated the experimental group would have a mean reduction of 4.5 UUI episodes per day with a SD of 1.5 UUI episodes per day. To detect such a difference with 80% power and alpha 0.05, we would need 88 participants for our analysis. To allow for a 12% dropout rate, our goal was to enroll 100 women.
Statistical Test of Hypothesis P-Value 0.2
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Change in 24hr Pad Weight
Hide Description 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.
Time Frame Baseline, 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Oxybutynin Plus PTNS Placebo Plus PTNS
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 15 10
Median (Inter-Quartile Range)
Unit of Measure: grams
-52
(-201.5 to -15.1)
-8
(-103.5 to 13.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oxybutynin Plus PTNS, Placebo Plus PTNS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Other Pre-specified Outcome
Title Change in the Patient Global Impression of Improvement (PGI-I)
Hide Description 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).
Time Frame Baseline, 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Oxybutynin Plus PTNS Placebo Plus PTNS
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 16 15
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
-1
(-1 to 0)
-1
(-1 to 0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oxybutynin Plus PTNS, Placebo Plus PTNS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Other Pre-specified Outcome
Title Change in the Overactive Bladder Questionnaire Short Form (OABq-SF) Part 1
Hide Description 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.
Time Frame Baseline, 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Oxybutynin Plus PTNS Placebo Plus PTNS
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 15 16
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
-13.3
(-25 to -5.1)
-10
(-23.3 to 6.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oxybutynin Plus PTNS, Placebo Plus PTNS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Other Pre-specified Outcome
Title Change in the Overactive Bladder Questionnaire Short Form (OABq-SF) Part 2
Hide Description 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.
Time Frame Baseline, 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Oxybutynin Plus PTNS Placebo Plus PTNS
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 14 15
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
9.2
(6.5 to 18.1)
0
(-7.7 to 11.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oxybutynin Plus PTNS, Placebo Plus PTNS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Other Pre-specified Outcome
Title Change in the Urinary Distress Inventory (UDI-6)
Hide Description 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.
Time Frame Baseline, 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
1 patient in the oxybutynin+PTNS group did not complete the 6 week UDI-6 questionnaire so was not included in the analysis.
Arm/Group Title Oxybutynin Plus PTNS Placebo Plus PTNS
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 17 16
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
-11.1
(-16.6 to 0)
5.5
(-16.6 to 13.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oxybutynin Plus PTNS, Placebo Plus PTNS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
7.Other Pre-specified Outcome
Title Change in the Incontinence Impact Questionnaire (IIQ-7)
Hide Description 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.
Time Frame Baseline, 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
1 patient in the oxybutynin+PTNS group did not complete the 6 week IIQ-7 questionnaire so was not included in the analysis.
Arm/Group Title Oxybutynin Plus PTNS Placebo Plus PTNS
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 17 16
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
-9.5
(-19 to 0)
-2.4
(-11.9 to 4.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oxybutynin Plus PTNS, Placebo Plus PTNS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
8.Other Pre-specified Outcome
Title Change in Treatment Satisfaction Questionnaire for Medication, Version Two (TSQMvII) - Global Satisfaction Domain
Hide Description 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.
Time Frame Baseline, 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Oxybutynin Plus PTNS Placebo Plus PTNS
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 17 14
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
83.3
(50 to 100)
70.8
(50 to 83.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oxybutynin Plus PTNS, Placebo Plus PTNS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.73
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
9.Other Pre-specified Outcome
Title Change in Treatment Satisfaction Questionnaire for Medication, Version Two (TSQMvII) - Side Effects Domain
Hide Description 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.
Time Frame Baseline, 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Two patients in the placebo+PTN group did not complete the 6 week TSQMvII questionnaire so was not included in the analysis.
Arm/Group Title Oxybutynin Plus PTNS Placebo Plus PTNS
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 18 14
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
0
(0 to 41.7)
0
(0 to 50)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oxybutynin Plus PTNS, Placebo Plus PTNS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.94
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame Baseline to 6 weeks
Adverse Event Reporting Description 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.
 
Arm/Group Title Oxybutynin Plus PTNS Placebo Plus PTNS
Hide Arm/Group Description

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

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

All-Cause Mortality
Oxybutynin Plus PTNS Placebo Plus PTNS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)      0/16 (0.00%)    
Hide Serious Adverse Events
Oxybutynin Plus PTNS Placebo Plus PTNS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/18 (0.00%)      0/16 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Oxybutynin Plus PTNS Placebo Plus PTNS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/18 (0.00%)      3/16 (18.75%)    
Cardiac disorders     
Possible cardiac symptons  [1]  0/18 (0.00%)  0 1/16 (6.25%)  1
Eye disorders     
Glaucoma   0/18 (0.00%)  0 1/16 (6.25%)  1
Skin and subcutaneous tissue disorders     
Skin Rash   0/18 (0.00%)  0 1/16 (6.25%)  1
Indicates events were collected by systematic assessment
[1]
chest pain, shortness of breath, headache
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nazema Siddiqui MD
Organization: Duke University
EMail: nazema.siddiqui@duke.edu
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02176642    
Other Study ID Numbers: Pro00052742
First Submitted: June 25, 2014
First Posted: June 27, 2014
Results First Submitted: November 13, 2017
Results First Posted: January 23, 2018
Last Update Posted: January 23, 2018