Urinary Incontinence (UI)NCT07742176
Transcutaneous Tibial Nerve Stimulation for Urinary Incontinence After Radical Prostatectomy
A study testing Active Transcutaneous Tibial Nerve Stimulation (TTNS) and Pelvic Floor Muscle Training (PFMT) in people with Urinary Incontinence (UI) and Prostatectomy, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Urinary Incontinence (UI), Prostatectomy
- What is being tested?
- Active Transcutaneous Tibial Nerve Stimulation (TTNS) and Pelvic Floor Muscle Training (PFMT)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2026to Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Pamukkale University Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Pamukkale, Denizli, 20160
Yusuf YOLCU, MD, +90 258 296 16 02, dr.yusufyolcu@gmail.com
Necmettin Yıldız, MD
About this study
Official title: Efficacy of Transcutaneous Tibial Nerve Stimulation in Patients With Urinary Incontinence After Radical Prostatectomy: A Randomized, Double-Blind, Sham-Controlled Clinical 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.
Read the detailed description
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).
- Conditions
- Urinary Incontinence (UI), Prostatectomy
- Being tested
- Active Transcutaneous Tibial Nerve Stimulation (TTNS), Sham Transcutaneous Tibial Nerve Stimulation (TTNS), Pelvic Floor Muscle Training (PFMT)
- Keywords
- Radical prostatectomy, Urinary incontinence, Pelvic floor muscle training, Transcutaneous tibial nerve stimulation
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Transcutaneous Tibial Nerve Stimulation (TTNS)Device
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)Device
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)Behavioural
A 12-week progressive home-based pelvic floor muscle training program with graded contraction/relaxation durations and postural progression.
| Study group | Role | What they receive |
|---|---|---|
| Active TTNS Group | Experimental | 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. Receives: Device: Active Transcutaneous Tibial Nerve Stimulation (TTNS); Behavioral: Pelvic Floor Muscle Training (PFMT) |
| Sham TTNS Group | Sham comparator | 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. Receives: Device: Sham Transcutaneous Tibial Nerve Stimulation (TTNS); Behavioral: Pelvic Floor Muscle Training (PFMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline (T0) and Week 12 (T1)
Secondary outcomes (11)
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 12 (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urinary Incontinence (UI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Necmettin Yildiz, Pamukkale University
- Investigators
- Necmettin Yıldız, MD, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742176
- Sponsor's protocol ID
- E-60116787-020-895730
- Status last verified
- Oct 2026
- First submitted
- 27 Jul 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Akin Y, Yorulmaz EM, Kose O, Ozcan S, Gorgel SN, Tumer E. Impact of Posterior Tibial Nerve Stimulation on Early Continence Following Extraperitoneal Laparoscopic Radical Prostatectomy With Three Trocars. Neurourol Urodyn. 2025 Feb;44(2):360-366. doi: 10.1002/nau.25659. Epub 2025 Jan 6.
PubMed 39760411Yamanishi T, Mizuno T, Watanabe M, Honda M, Yoshida K. Randomized, placebo controlled study of electrical stimulation with pelvic floor muscle training for severe urinary incontinence after radical prostatectomy. J Urol. 2010 Nov;184(5):2007-12. doi: 10.1016/j.juro.2010.06.103. Epub 2010 Sep 20.
PubMed 20850831