Active Transcutaneous Tibial Nerve Stimulation (TTNS)Sham Transcutaneous Tibial Nerve Stimulation (TTNS)Pelvic Floor Muscle Training (PFMT)
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.
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.
Pelvic Floor Muscle Training (PFMT): A 12-week progressive home-based pelvic floor muscle training program with graded contraction/relaxation durations and postural progression.
Study 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.
Eligibility
Sex
MALE
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Change in 24-Hour Pad Test — Baseline (T0) and Week 12 (T1) Incontinence severity by ICS-standardized 24-hour pad test; wet minus dry pad weight equals urine leakage (grams/day). Change from baseline (T0) to Week 12 (T1).
Trial sites (1)
Facility
City
Region
Status
Pamukkale University Faculty of Medicine, Department of Physical Medicine and Rehabilitation
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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