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

• Sponsor: Duke University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02176642
• Collaborator: Society of Urodynamics and Female Pelvic Medicine & Urogenital Reconstruction (Other)
• Enrollment: 55
• Locations: 2
• Arms: 2
• Duration (Months): 27.7
• Patients Per Site: 27.5
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Urge Incontinence	Drug: Oxybutynin extended release; Device: Posterior Tibial Nerve Stimulation; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Double-Blind Randomized Controlled Trial of Extended Release Oxybutynin Versus Placebo in Women Receiving Posterior Tibial Nerve Stimulation for Treatment of Urgency Urinary Incontinence
• Study Start Date: Aug 1, 2014
• Actual Primary Completion Date: Nov 21, 2016
• Actual Study Completion Date: Nov 21, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Oxybutynin extended release; 5mg tablet taken by mouth daily for 6 weeks; Other Names: Ditropan XL ; Device: Posterior Tibial Nerve Stimulation; In office therapy administered for 30 minutes once every week for a total of 6 weeks; Other Names: Urgent PC Neuromodulation system
Placebo Comparator: 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.	Device: Posterior Tibial Nerve Stimulation; In office therapy administered for 30 minutes once every week for a total of 6 weeks; Other Names: Urgent PC Neuromodulation system ; Drug: Placebo; Tablet taken by mouth daily for 6 weeks; Other Names: Dextrose powder

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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 Outcome Measures

1. 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).

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Female patients

• 18 years of age

• 3 UUI episodes on a 3-day bladder diary

• Urge predominant ( > 50% of total incontinence episodes) urinary incontinence based on a three-day bladder diary

• Existing insurance coverage of PTNS therapy.

• Ability to undergo weekly PTNS treatments in clinic for 6 week period of time and complete all study related items

• Not on an anticholinergic or beta agonist medication or, if they are, willing to undergone a three week washout period prior to randomization

Exclusion Criteria:

• Any previous PTNS therapy, intra-detrusor botulinum toxin injections, or implanted sacral neuromodulation

• Contraindication to anticholinergic therapy (narrow-angle glaucoma or gastric retention) or PTNS therapy (implanted pacemaker/defibrillator or peripheral neuropathy)

• Symptomatic urinary tract infection that has not resolved prior to randomization

• Surgical treatment for stress urinary incontinence or pelvic organ prolapse recommended or planned at time of enrollment

• Surgically altered detrusor muscle

• Known diagnosis or history of neurogenic bladder, post void residual volume >150ml, bladder malignancy, interstitial cystitis/painful bladder syndrome, or pelvic radiation

• Surgery for pelvic organ prolapse or stress urinary incontinence within the previous 3 months

• Pregnancy, lactation, or planned pregnancy during study period

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke Urogynecology	Durham	North Carolina	United States	27707
2	Duke OB/GYN Consultants of Raleigh	Raleigh	North Carolina	United States	27607

Sponsors and Collaborators

• Duke University
• Society of Urodynamics and Female Pelvic Medicine & Urogenital Reconstruction

Investigators

• Principal Investigator: Nazema Y Siddiqui, MD, MHS, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT02176642
• Other Study ID Numbers: Pro00052742
• First Posted: Jun 27, 2014
• Last Update Posted: Jan 23, 2018
• Last Verified: Dec 1, 2017

• Keywords provided by Duke University: Urinary Urge Incontinence; Posterior Tibial Nerve Stimulation; PTNS; Neuromodulation; Oxybutynin; Anticholinergic Medication
• Additional relevant MeSH terms: Urinary Incontinence, Urge; Oxybutynin

Study Results

Participant Flow

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 Detail	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
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

Baseline Characteristics

Arm/Group Title	Oxybutynin Plus PTNS	Placebo Plus PTNS	Total
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 Participants	18	16	34
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	72.7 (9.8)	70.4 (8.5)	71.6 (9.2)
Sex: Female, Male (Count of Participants)
Female	18 100%	16 100%	34 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	18 100%	16 100%	34 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	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%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	18 100%	16 100%	34 100%

Outcome Measures

1. Primary Outcome

Title	Change in Median Number of UUI Episodes Per Day
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

Outcome Measure Data

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
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
Measure Participants	15	13
Median (Inter-Quartile Range) [Urge urinary incontinence episodes/day]	-0.3	0.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Oxybutynin Plus PTNS, Placebo Plus PTNS
	Comments
	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
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Secondary Outcome

Title	Change in 24hr Pad Weight
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

Outcome Measure Data

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
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
Measure Participants	15	10
Median (Inter-Quartile Range) [grams]	-52	-8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Oxybutynin Plus PTNS, Placebo Plus PTNS
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.4
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Other Pre-specified Outcome

Title	Change in the Patient Global Impression of Improvement (PGI-I)
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

Outcome Measure Data

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
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
Measure Participants	16	15
Median (Inter-Quartile Range) [units on a scale]	-1	-1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Oxybutynin Plus PTNS, Placebo Plus PTNS
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.48
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

4. Other Pre-specified Outcome

Title	Change in the Overactive Bladder Questionnaire Short Form (OABq-SF) Part 1
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

Outcome Measure Data

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
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
Measure Participants	15	16
Median (Inter-Quartile Range) [units on a scale]	-13.3	-10

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Oxybutynin Plus PTNS, Placebo Plus PTNS
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.26
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

5. Other Pre-specified Outcome

Title	Change in the Overactive Bladder Questionnaire Short Form (OABq-SF) Part 2
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

Outcome Measure Data

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
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
Measure Participants	14	15
Median (Inter-Quartile Range) [units on a scale]	9.2	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Oxybutynin Plus PTNS, Placebo Plus PTNS
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.06
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

6. Other Pre-specified Outcome

Title	Change in the Urinary Distress Inventory (UDI-6)
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

Outcome Measure Data

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
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
Measure Participants	17	16
Median (Inter-Quartile Range) [units on a scale]	-11.1	5.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Oxybutynin Plus PTNS, Placebo Plus PTNS
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

7. Other Pre-specified Outcome

Title	Change in the Incontinence Impact Questionnaire (IIQ-7)
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

Outcome Measure Data

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
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
Measure Participants	17	16
Median (Inter-Quartile Range) [units on a scale]	-9.5	-2.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Oxybutynin Plus PTNS, Placebo Plus PTNS
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.44
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

8. Other Pre-specified Outcome

Title	Change in Treatment Satisfaction Questionnaire for Medication, Version Two (TSQMvII) - Global Satisfaction Domain
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

Outcome Measure Data

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
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
Measure Participants	17	14
Median (Inter-Quartile Range) [units on a scale]	83.3	70.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Oxybutynin Plus PTNS, Placebo Plus PTNS
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.73
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

9. Other Pre-specified Outcome

Title	Change in Treatment Satisfaction Questionnaire for Medication, Version Two (TSQMvII) - Side Effects Domain
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

Outcome Measure Data

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
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
Measure Participants	18	14
Median (Inter-Quartile Range) [units on a scale]	0	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Oxybutynin Plus PTNS, Placebo Plus PTNS
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.94
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/16 (0%)
Serious Adverse Events
	Oxybutynin Plus PTNS		Placebo Plus PTNS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	Oxybutynin Plus PTNS		Placebo Plus PTNS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		3/16 (18.8%)
Cardiac disorders
Possible cardiac symptons	0/18 (0%)	0	1/16 (6.3%)	1
Eye disorders
Glaucoma	0/18 (0%)	0	1/16 (6.3%)	1
Skin and subcutaneous tissue disorders
Skin Rash	0/18 (0%)	0	1/16 (6.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.