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

Phase 4

Terminated

• Conditions: Urinary Urge Incontinence
• Interventions: Device: Posterior Tibial Nerve Stimulation; Drug: Oxybutynin extended release; Drug: Placebo

• Registration Number: NCT02176642
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-25
• Study First Submitted QC: 2014-06-25
• Study First Posted: 2014-06-27
• Study Start: 2014-08
• Primary Completion: 2016-11-21
• Study Completion: 2016-11-21
• Results First Submitted: 2017-11-13
• Status Verified: 2017-12
• Results First Submitted QC: 2017-12-28
• Last Update Submitted: 2017-12-28
• Results First Posted: 2018-01-23
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 55

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo plus PTNS	Posterior Tibial Nerve Stimulation	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.
Oxybutynin plus PTNS	Posterior Tibial Nerve Stimulation	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 plus PTNS	Oxybutynin extended release	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	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (2)

Duke Urogynecology; 🇺🇸 Durham, North Carolina, United States

Duke OB/GYN Consultants of Raleigh; 🇺🇸 Raleigh, North Carolina, United States