Transcutaneous Tibial Nerve Stimulation for Urinary Incontinence After Radical Prostatectomy (NCT07742176) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Transcutaneous Tibial Nerve Stimulation for Urinary Incontinence After Radical Prostatectomy
Turkey (Türkiye)104 participantsStarted 2026-08
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.