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NCT07742176

Overview

NCT ID: NCT07742176
Lead Sponsor: Pamukkale UniversityOTHER
Official Title: Efficacy of Transcutaneous Tibial Nerve Stimulation in Patients With Urinary Incontinence After Radical Prostatectomy: A Randomized, Double-Blind, Sham-Controlled Clinical Trial
Brief 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.
Conditions: Urinary Incontinence (UI)

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Aug 3, 2026Actual
Start Date: Jul 2026Estimated
Primary Completion Date: Dec 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Male
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Male patients aged 18-80 years

Urinary incontinence greater than 8 g on the 24-hour pad test after radical prostatectomy

Postoperative catheter removed, between 2 weeks and 1 year after surgery

Willing to complete study questionnaires and able to understand the procedures, benefits, and possible side effects

Able to provide written informed consent

Exclusion Criteria:

History of urinary incontinence prior to radical prostatectomy

History of conservative treatment after prostatectomy, including tibial nerve stimulation, magnetic stimulation, or electrical stimulation

Prolonged indwelling urethral catheterization (more than 15 days)

Anatomical/post-traumatic malformations or active skin conditions at electrode sites preventing electrode application or stimulation

History of prior urological surgery

Inability to voluntarily contract pelvic floor muscles on digital rectal examination per ICS terminology

Currently receiving or having received radiotherapy

Urethral stricture or active urinary tract infection

Heart failure, pacemaker, or implanted defibrillator

History of transurethral resection of the prostate (TURP) for benign prostatic hyperplasia

Use of medications that may affect bladder function (antimuscarinics, duloxetine, tricyclic antidepressants, etc.)

History of neurogenic bladder or peripheral/central neurological pathology

Inability to attend treatment sessions regularly due to distance or physical limitations

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 104Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Contacts and Locations

Central Contacts: Yusuf YOLCU, MDContact
dr.yusufyolcu@gmail.com+90 258 296 16 02

Similar Studies

Participant Group/Arms

Active TTNS GroupExperimental

Pelvic floor muscle training (PFMT) plus active TTNS, delivered via Enraf Nonius Myomed 932, unilateral, 20 Hz, 200 microseconds pulse width, continuous mode; once weekly, 30 minutes per session, for 12 weeks (12 sessions total), plus a 12-week progressive home-based PFMT program.

Device: Active Transcutaneous Tibial Nerve Stimulation (TTNS)

Behavioral: Pelvic Floor Muscle Training (PFMT)

Sham TTNS GroupSham Comparator

Pelvic floor muscle training (PFMT) plus sham TTNS, using an identical device, electrode placement, session duration, frequency, and total duration; a four-electrode masking protocol is applied with brief initial sensory stimulation followed by gradual current reduction to zero. Same PFMT program as the active arm.

Device: Sham Transcutaneous Tibial Nerve Stimulation (TTNS)