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Not Yet Recruiting NCT07742176

Transcutaneous Tibial Nerve Stimulation for Urinary Incontinence After Radical Prostatectomy

Conditions: Urinary Incontinence (UI), Prostatectomy

Sex: Male
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 104
Sponsor: Pamukkale University

Location: Pamukkale University Faculty of Medicine, Department of Physical Medicine and Rehabilitation Pamukkale Denizli

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 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07742176). StuddyBuddy aggregates publicly available trial information.