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

NCT03535857 | Terminated Results FDA Device

• 1 other identifier: STUDY19100230
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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

Conditions

Overactive Bladder Syndrome; Urinary Incontinence, Urge

Keywords

overactive bladder; OAB; urge urinary incontinence; PTNS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Daily Number of Voids From Baseline to 12 Weeks or Last Measurement

  12 weeks or last measurement

• Change in Number of Incontinence Episodes Per 24 Hours From Baseline to 12 Weeks or Last Measurement

  12 weeks or last measurement

• Change in Nocturia Episodes From Baseline to 12 Weeks or Last Measurement

  12 weeks or last measurement

• Impact of Treatment on Quality of Life From Baseline to 12 Weeks or Last Measurement

  12 weeks or last measurement

Study Arms (2)

Unilateral PTNS

ACTIVE COMPARATOR

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

Bilateral PTNS

EXPERIMENTAL

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

Interventions

PTNS DEVICE

Use of PTNS on the ankle for 30 minutes

Bilateral PTNS; Unilateral PTNS

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients over the age of 18 who have previously tried and failed, or were unable to tolerate, behavioral therapy
• Patients who consent to participate in the study
• Patients on pharmacologic therapy at the time of recruitment can continue their treatment

You may not qualify if:

• Pregnant patients
• Patients with pacemakers of implantable defibrillators
• Patients with neurogenic bladder
• Patients who have received Botox or have an implant for sacral nerve stimulation
• Patients with uncontrolled bleeding disorder
• Patients with unhealed ulcers or with leg edema surrounding medial malleolus

Sponsors & Collaborators

• Gnankang Sarah Napoe: lead

Study Sites (2)

Gnankang Sarah Napoe

Pittsburgh, Pennsylvania, 15203, United States

Location

WIHRI

Providence, Rhode Island, 02905, United States

Location

Related Publications (1)

• Napoe GS, Hall E, Dasgupta P, Myers DL, Wohlrab KJ. Randomized trial of unilateral versus bilateral percutaneous tibial nerve stimulation for the treatment of overactive bladder. World J Urol. 2025 Dec 4;44(1):15. doi: 10.1007/s00345-025-06107-0.

  PMID: 41342952 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Urge; Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases

Results Point of Contact

• Title: Dr, Gnankang Sarah Napoe
• Organization: University of Pittsburgh

napoegs@upmc.edu

412-641-7850

Study Officials

• G. Sarah Napoe, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Kyle Wohlrab, MD

  Women and Infants Hospital of Rhode Island

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: May 24, 2018
• Study Start: April 17, 2018
• Primary Completion: September 8, 2023
• Study Completion: September 8, 2023
• Last Updated: April 15, 2025
• Results First Posted: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)