Urinary Incontinence (UI), Prostatectomy
Conditions
Keywords
Radical prostatectomy, Urinary incontinence, Pelvic floor muscle training, Transcutaneous tibial nerve stimulation
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. 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).
Interventions
DEVICEActive Transcutaneous Tibial Nerve Stimulation (TTNS)
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.
BEHAVIORALPelvic Floor Muscle Training (PFMT)
A 12-week progressive home-based pelvic floor muscle training program with graded contraction/relaxation durations and postural progression.
Sponsors
Pamukkale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 24-Hour Pad Test | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Voiding Frequency (Three-Day Voiding Diary) | Baseline (T0) and Week 12 (T1) | 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). |
| Change in Maximum Voluntary Contraction Pressure (Perineometry) | Baseline (T0) and Week 12 (T1) | 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). |
| Change in Overactive Bladder Symptom Severity (OAB-V8) | Baseline (T0) and Week 12 (T1) | Turkish-validated 8-item questionnaire, each item scored 0-5 (total 0-40); higher scores indicate greater symptom severity. Change from T0 to T1. |
| Change in Quality of Life (Incontinence Impact Questionnaire-Short Form, IIQ-7) | Baseline (T0) and Week 12 (T1) | 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. |
| Change in Anxiety and Depression Levels (Hospital Anxiety and Depression Scale, HADS) | Baseline (T0) and Week 12 (T1) | 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. |
| Change in Sexual Function (International Index of Erectile Function, IIEF-15) | Baseline (T0) and Week 12 (T1) | Turkish-validated 15-item index assessing erectile and sexual function; higher scores indicate better function. Change from T0 to T1. |
| Continence Rate | Week 12 (T1) | Patients with 8 g or less leakage on the 24-hour pad test are classified as continent; the proportion is compared between groups. |
| Treatment Response (Cure and Improvement Rates) | Week 12 (T1) | 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. |
| Treatment Satisfaction Level (5-point Likert Scale) | Week 12 (T1) | Patients rate satisfaction on a 5-point Likert scale (1 = not satisfied at all, 5 = very satisfied). Assessed at T1 only. |
| Procedure-Related Discomfort Level (5-point Likert Scale) | Week 12 (T1) | Patients rate procedure-related discomfort on a 5-point Likert scale (1 = no discomfort at all, 5 = severe discomfort). Assessed at T1 only. |
| Blinding Success | Week 12 (T1) | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTYusuf YOLCU, MD
PRINCIPAL_INVESTIGATORNecmettin Yıldız, MD
Pamukkale University Faculty of Medicine
Outcome results
None listed