Effectiveness of Bilateral PTNS Compared to Unilateral PTNS for the Treatment of Overactive Bladder/Urge Incontinence

Gnankang Sarah Napoe36 enrolled

Overview

This study is designed to evaluate whether bilateral Posterior Tibial Nerve Stimulation is more effective than unilateral Posterior Tibial Nerve Stimulation at treating overactive bladder and urge urinary incontinence

Percutaneous tibial nerve stimulation (PTNS) is an accepted treatment for overactive bladder that can be accomplished in the office with minimal side effects. It is currently carried out by stimulating one of the posterior tibial nerves unilaterally. The aim of this study is to determine whether bilateral percutaneous tibial nerve stimulation is more effective than unilateral stimulation. Patients with a diagnosis of overactive bladder who have previously failed lifestyle changes and/or pharmacologic therapy will be offered percutaneous tibial nerve stimulation. Enrolled patients will be randomized into two groups. The control group will receive the traditional unilateral treatment of PTNS. The intervention group will receive bilateral PTNS treatment. Intervention success will be measured by improvement in overactive bladder symptoms assessed by improvement in the scores on the overactive bladder questionnaire symptoms bother and decrease in number of voids, nocturia episodes and incontinence episodes as reported in the voiding diary

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Overactive Bladder Syndrome Urinary Incontinence, Urge

Interventions

PTNSDEVICE

Use of PTNS on the ankle for 30 minutes

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Female patients over the age of 18 who have previously tried and failed, or were unable to tolerate, behavioral therapy 2. Patients who consent to participate in the study 3. Patients on pharmacologic therapy at the time of recruitment can continue their treatment Exclusion Criteria: 1. Pregnant patients 2. Patients with pacemakers of implantable defibrillators 3. Patients with neurogenic bladder 4. Patients who have received Botox or have an implant for sacral nerve stimulation 5. Patients with uncontrolled bleeding disorder 6. Patients with unhealed ulcers or with leg edema surrounding medial malleolus

Locations (2)

Gnankang Sarah Napoe

Pittsburgh, Pennsylvania, United States

WIHRI

Providence, Rhode Island, United States

Outcomes

Primary Outcomes

Change in Overactive Bladder Questionnaire Score From Baseline to 12 Weeks or Last Measurement

Overactive Bladder questionnaire short form (OABqSF) symptom severity questionnaire was administered at baseline, 4 weeks, 8 weeks then 12 weeks. The OABqSF score ranges from 0 to 100. Those with more bothersome symptoms have higher scores. The investigators expected more improvement in symptoms from participants receiving bilateral stimulation compared to those with unilateral stimulation.