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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Active Transcutaneous Tibial Nerve Stimulation (TTNS)
DeviceActive 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)
DeviceSham 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)
BehavioralA 12-week progressive home-based pelvic floor muscle training program with graded contraction/relaxation durations and postural progression.
Treatment groups
104 Participants
are divided into 2 treatment groupsGroup A: Active TTNS GroupExperimental treatment 2 interventions
Group B: Sham TTNS GroupSham comparator 2 interventions
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: