MedTrace Logo

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

NCT02176642 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2018-01-23

Study results available
· View outcomes & findings →

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

Interventions

DRUG

Oxybutynin extended release

5mg tablet taken by mouth daily for 6 weeks

DEVICE

Posterior Tibial Nerve Stimulation

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

DRUG

Placebo

Tablet taken by mouth daily for 6 weeks

Sponsors & Collaborators

  • Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction

    collaborator OTHER

  • Duke University

    lead OTHER

Principal Investigators

  • Nazema Y Siddiqui, MD, MHS · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-11-21
Completion
2016-11-21

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02176642 on ClinicalTrials.gov