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

NCT ID: NCT02176642

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2016-11-21

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.

Conditions

Urinary Urge Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Oxybutynin extended release

Intervention Type: DRUG

5mg tablet taken by mouth daily for 6 weeks

Posterior Tibial Nerve Stimulation

Intervention Type: DEVICE

In office therapy administered for 30 minutes once every week for a total of 6 weeks

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.

Group Type: PLACEBO_COMPARATOR

Posterior Tibial Nerve Stimulation

Intervention Type: DEVICE

In office therapy administered for 30 minutes once every week for a total of 6 weeks

Placebo

Intervention Type: DRUG

Tablet taken by mouth daily for 6 weeks

Interventions

Oxybutynin extended release

5mg tablet taken by mouth daily for 6 weeks

Intervention Type: DRUG

Posterior Tibial Nerve Stimulation

In office therapy administered for 30 minutes once every week for a total of 6 weeks

Intervention Type: DEVICE

Placebo

Tablet taken by mouth daily for 6 weeks

Intervention Type: DRUG

Other Intervention Names

Ditropan XL; Urgent PC Neuromodulation system; Dextrose powder

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nazema Y Siddiqui, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke Urogynecology

Durham, North Carolina, United States

Duke OB/GYN Consultants of Raleigh

Raleigh, North Carolina, United States

Countries

United States

Other Identifiers

Pro00052742

Identifier Type: -

Identifier Source: org_study_id