An interventional study of Active Transcutaneous Tibial Nerve Stimulation (TTNS) and Sham Transcutaneous Tibial Nerve Stimulation (TTNS) in Urinary Incontinence (UI) and Prostatectomy, sponsored by Pamukkale University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Pamukkale University · Not applicable, Interventional, and Treatment
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.
The incidence of UI after RP ranges from 17-77% at 1 month, 7-53% at 3 months, and 3-38% at 6 months postoperatively, with full continence recovery typically taking up to one year. PFMT is the most commonly used conservative approach for managing post-RP UI; however, exercise protocols reported in the literature (contraction number, duration, position) are not standardized. In recent years, peripheral neuromodulation techniques, particularly TTNS, have increasingly been studied as an adjunct to PFMT. Existing literature on this topic is limited to retrospective studies without sham control groups, leaving it unclear whether the observed clinical improvement reflects a true neuromodulatory effect or the natural recovery process.
This study is the first prospective, randomized, double-blind, sham-controlled clinical trial comparing the efficacy of active TTNS added to PFMT versus sham TTNS added to PFMT.
Design: Participants are stratified by postoperative time (1-3 months, 3-6 months, 6-12 months) and randomized within each stratum using blocks of four at a 1:1 ratio into two groups.
Interventions - Group 1 (n=52): PFMT + 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. Group 2 (n=52): PFMT + Sham TTNS, identical device/duration/frequency, using a four-electrode masking protocol with brief initial sensory stimulation followed by gradual current reduction to zero.
Both groups also follow a 12-week progressive home-based PFMT program.
Blinding: This is a double-blind trial. The participant and the outcome-assessing/data-collecting investigator are blinded to treatment allocation, and the statistician analyzes coded group labels blinded to group identity. The treating clinician, who monitors the motor threshold during stimulation, cannot be blinded but is fully isolated from clinical assessment processes.
Assessment time points: Baseline (T0) and end of 12 weeks (T1).
Sample size: Based on an a priori power analysis (Yamanishi et al. reference data), effect size d=0.585, alpha=0.05, 80% power yielded a minimum of 47 patients per group; accounting for 10% dropout, the final sample size was set at 104 (52 per group).
983 studies on the registry are indexed under Urinary Incontinence; 180 are open to participants now.
This study's planned enrollment of 104 is above the median of 66 across 739 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Pamukkale University is the lead sponsor of 342 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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) · Behavioral: Pelvic Floor Muscle Training (PFMT)
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 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.
A 12-week progressive home-based pelvic floor muscle training program with graded contraction/relaxation durations and postural progression.
Change in 24-Hour Pad Test
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).
Time frame: Baseline (T0) and Week 12 (T1)
Change in Voiding Frequency (Three-Day Voiding Diary)
Voiding frequency (number of voids per day) recorded over three consecutive days in a voiding diary; the arithmetic mean of the three days is used. Change from baseline (T0) to Week 12 (T1).
Time frame: Baseline (T0) and Week 12 (T1)
Change in Maximum Voluntary Contraction Pressure (Perineometry)
Maximum voluntary contraction pressure of the pelvic floor muscles (cmH2O) measured with an anal-probe perineometer (Peritron 9300A); the highest of three attempts is used. Change from baseline (T0) to Week 12 (T1).
Time frame: Baseline (T0) and Week 12 (T1)
Change in Overactive Bladder Symptom Severity (OAB-V8)
Turkish-validated 8-item questionnaire, each item scored 0-5 (total 0-40); higher scores indicate greater symptom severity. Change from T0 to T1.
Time frame: Baseline (T0) and Week 12 (T1)
Change in Quality of Life (Incontinence Impact Questionnaire-Short Form, IIQ-7)
Turkish-validated 7-item form, each item scored 0-3 (total 0-21); higher scores indicate worse quality of life. Change from T0 to T1.
Time frame: Baseline (T0) and Week 12 (T1)
Change in Anxiety and Depression Levels (Hospital Anxiety and Depression Scale, HADS)
Turkish-validated 14-item scale with two subscales (anxiety and depression, 7 items each), each item scored 0-3, each subscale 0-21; higher scores indicate more severe symptoms. Change from T0 to T1.
Time frame: Baseline (T0) and Week 12 (T1)
Change in Sexual Function (International Index of Erectile Function, IIEF-15)
Turkish-validated 15-item index assessing erectile and sexual function; higher scores indicate better function. Change from T0 to T1.
Time frame: Baseline (T0) and Week 12 (T1)
Continence Rate
Patients with 8 g or less leakage on the 24-hour pad test are classified as continent; the proportion is compared between groups.
Time frame: Week 12 (T1)
Treatment Response (Cure and Improvement Rates)
Treatment response classified based on change in the number of incontinence episodes: a change of more than 50% is classified as improvement, complete absence of incontinence as cure, and a change of 50% or less as persistence of symptoms. Rates compared between groups.
Time frame: Week 12 (T1)
Treatment Satisfaction Level (5-point Likert Scale)
Patients rate satisfaction on a 5-point Likert scale (1 = not satisfied at all, 5 = very satisfied). Assessed at T1 only.
Time frame: Week 12 (T1)
Procedure-Related Discomfort Level (5-point Likert Scale)
Patients rate procedure-related discomfort on a 5-point Likert scale (1 = no discomfort at all, 5 = severe discomfort). Assessed at T1 only.
Time frame: Week 12 (T1)
Blinding Success
At the end of treatment, patients are asked which treatment they believe they received (active, sham, or don't know). Responses are used to assess whether patient blinding was successfully maintained. Assessed at T1 only.
Time frame: Week 12 (T1)
Plan to share: Undecided
Start is estimated for Nov 2026; primary completion for Dec 2027, 13 months later.
Of 301 non-industry interventional studies with no phase under Urinary Incontinence, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's planned 13 months is below that.
Counting every sponsor, half of 364 studies reached it within 15 months; a quarter within 7 and three quarters within 35.
Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Nov 2026, on Oct 23, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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