Transcutaneous Tibial Nerve Stimulation for Urinary Incontinence After Radical Prostatectomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-80
SponsorPamukkale University
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Active Transcutaneous Tibial Nerve Stimulation (TTNS)
- Sham Transcutaneous Tibial Nerve Stimulation (TTNS)
- Pelvic Floor Muscle Training (PFMT)
Treatment groups
104 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov