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NOT YET RECRUITING
NCT07742176
NA

Transcutaneous Tibial Nerve Stimulation for Urinary Incontinence After Radical Prostatectomy

Sponsor: Pamukkale University

View on ClinicalTrials.gov

Summary

Urinary incontinence (UI) after radical prostatectomy (RP) is a common postoperative complication that significantly affects quality of life. This study aims to evaluate the efficacy of active transcutaneous tibial nerve stimulation (TTNS), added to standard pelvic floor muscle training (PFMT), compared with sham TTNS, in patients with UI after RP. The study uses a randomized, double-blind, sham-controlled design. The primary outcome is incontinence severity measured by the 24-hour pad test. Secondary outcomes include voiding diary parameters, pelvic floor muscle strength (perineometry), quality of life, sexual function, and anxiety/depression levels.

Official title: Efficacy of Transcutaneous Tibial Nerve Stimulation in Patients With Urinary Incontinence After Radical Prostatectomy: A Randomized, Double-Blind, Sham-Controlled Clinical Trial

Key Details

Gender

MALE

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

104

Start Date

2026-07

Completion Date

2027-12

Last Updated

2026-08-03

Healthy Volunteers

No

Interventions

DEVICE

Active Transcutaneous Tibial Nerve Stimulation (TTNS)

Active TTNS delivered via Enraf Nonius Myomed 932 at 20 Hz, 200 microseconds pulse width, continuous mode; once weekly, 30 minutes per session, for 12 weeks.

DEVICE

Sham Transcutaneous Tibial Nerve Stimulation (TTNS)

Sham TTNS using the same device and electrode placement; brief initial sensory stimulation followed by gradual current reduction to zero, so no current is delivered during the session. Once weekly, 30 minutes per session, for 12 weeks.

BEHAVIORAL

Pelvic Floor Muscle Training (PFMT)

A 12-week progressive home-based pelvic floor muscle training program with graded contraction/relaxation durations and postural progression.

Locations (1)

Pamukkale University Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Pamukkale, Denizli, Turkey (Türkiye)