Efficacy of Transcutaneous Tibial Nerve Stimulation in Patients With Urinary Incontinence After Radical Prostatectomy: A Randomized, Double-Blind, Sham-Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Pamukkale University
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- Change in 24-Hour Pad Test
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Active TTNS Group
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.
Intervention: Active Transcutaneous Tibial Nerve Stimulation (TTNS) (Device)
Active TTNS Group
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.
Intervention: Pelvic Floor Muscle Training (PFMT) (Behavioral)
Sham TTNS Group
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.
Intervention: Sham Transcutaneous Tibial Nerve Stimulation (TTNS) (Device)
Sham TTNS Group
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.
Intervention: Pelvic Floor Muscle Training (PFMT) (Behavioral)
Outcomes
Primary Outcomes
Change in 24-Hour Pad Test
Time Frame: Baseline (T0) and Week 12 (T1)
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).
Secondary Outcomes
- Change in Voiding Frequency (Three-Day Voiding Diary)(Baseline (T0) and Week 12 (T1))
- Change in Maximum Voluntary Contraction Pressure (Perineometry)(Baseline (T0) and Week 12 (T1))
- Change in Overactive Bladder Symptom Severity (OAB-V8)(Baseline (T0) and Week 12 (T1))
- Change in Quality of Life (Incontinence Impact Questionnaire-Short Form, IIQ-7)(Baseline (T0) and Week 12 (T1))
- Change in Anxiety and Depression Levels (Hospital Anxiety and Depression Scale, HADS)(Baseline (T0) and Week 12 (T1))
- Change in Sexual Function (International Index of Erectile Function, IIEF-15)(Baseline (T0) and Week 12 (T1))
- Continence Rate(Week 12 (T1))
- Treatment Response (Cure and Improvement Rates)(Week 12 (T1))
- Treatment Satisfaction Level (5-point Likert Scale)(Week 12 (T1))
- Procedure-Related Discomfort Level (5-point Likert Scale)(Week 12 (T1))
- Blinding Success(Week 12 (T1))
Investigators
Necmettin Yildiz
Professor
Pamukkale University