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

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

Study Overview

• Status: Terminated
• Conditions: Urinary Incontinence, Urge; Overactive Bladder Syndrome
• Intervention / Treatment: Device: PTNS

Detailed Description

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
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15203
      • Gnankang Sarah Napoe
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • WIHRI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Unilateral PTNS; 34 gauge needle inserted 3cm above the medial ankle on the ankle, and cables are connected to the PTNS stimulator device. Stimulation is provided, per manufacturer directions, over a 30-minute treatment period	Device: PTNS; Use of PTNS on the ankle for 30 minutes
Experimental: Bilateral PTNS; 34 gauge needle inserted 3cm above the medial ankle on both ankles, and cables are connected to the PTNS stimulator device. Stimulation is provided, per manufacturer directions, over a 30-minute treatment period	Device: PTNS; Use of PTNS on the ankle for 30 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks or last measurement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Daily Number of Voids From Baseline to 12 Weeks or Last Measurement	The change in number of voids was obtained by comparing number of voids at 12 weeks or last measurement compared to baseline number of voids.	12 weeks or last measurement
Change in Number of Incontinence Episodes Per 24 Hours From Baseline to 12 Weeks or Last Measurement	Change in number of incontinence episodes defined as number of incontinence episodes at completion of PTNS (12 weeks or last measurement) compared to baseline number of incontinence episodes.	12 weeks or last measurement
Change in Nocturia Episodes From Baseline to 12 Weeks or Last Measurement	Change in number of nocturia episodes defined as number of nighttime voids at completion of PTNS (12 weeks or last measurement) compared to baseline number of nighttime voids.	12 weeks or last measurement
Impact of Treatment on Quality of Life From Baseline to 12 Weeks or Last Measurement	The incontinence impact questionnaire was used to measure the impact on quality of life. The questionnaire score ranges from 0 to 100 with higher scores indicating worse quality of life.	12 weeks or last measurement

Collaborators and Investigators

• Sponsor: Gnankang Sarah Napoe
• Investigators: Principal Investigator: G. Sarah Napoe, MD, University of Pittsburgh; Principal Investigator: Kyle Wohlrab, MD, Women and Infants Hospital of Rhode Island

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2018
• Primary Completion (Actual): September 8, 2023
• Study Completion (Actual): September 8, 2023

Study Registration Dates

• First Submitted: May 8, 2018
• First Submitted That Met QC Criteria: May 22, 2018
• First Posted (Actual): May 24, 2018

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 6, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: overactive bladder; OAB; urge urinary incontinence; PTNS
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Urinary Bladder Diseases; Urinary Incontinence; Enuresis; Urinary Bladder, Overactive; Urinary Incontinence, Urge
• Other Study ID Numbers: STUDY19100230

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes