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

Not Applicable

Terminated

• Conditions: Urinary Incontinence, Urge; Overactive Bladder Syndrome
• Interventions: Device: PTNS

• Registration Number: NCT03535857
• Lead Sponsor: Gnankang Sarah Napoe

Brief Summary

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

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 Timeline

• Study Start: 2018-04-17
• Study First Submitted: 2018-05-08
• Study First Submitted QC: 2018-05-22
• Study First Posted: 2018-05-24
• Primary Completion: 2023-09-08
• Study Completion: 2023-09-08
• Results First Submitted: 2025-01-15
• Results First Submitted QC: 2025-03-20
• Status Verified: 2025-04
• Results First Posted: 2025-04-06
• Last Update Submitted: 2025-04-06
• Last Update Posted: 2025-04-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unilateral PTNS	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
Bilateral PTNS	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

Primary Outcome Measures

Name	Time	Method
Change in Overactive Bladder Questionnaire Score From Baseline to 12 Weeks or Last Measurement	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.

Secondary Outcome Measures

Name	Time	Method
Change in Daily Number of Voids From Baseline to 12 Weeks or Last Measurement	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.
Impact of Treatment on Quality of Life From Baseline to 12 Weeks or Last Measurement	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.
Change in Number of Incontinence Episodes Per 24 Hours From Baseline to 12 Weeks or Last Measurement	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.
Change in Nocturia Episodes From Baseline to 12 Weeks or Last Measurement	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.

Trial Locations

Locations (2)

Gnankang Sarah Napoe; 🇺🇸 Pittsburgh, Pennsylvania, United States

WIHRI; 🇺🇸 Providence, Rhode Island, United States