Transcutaneous Tibial Nerve Stimulation for Urinary Incontinence After Radical Prostatectomy

NCT07742176 | Not Yet Recruiting

• 1 other identifier: E-60116787-020-895730
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence (UI); Prostatectomy

Keywords

Radical prostatectomy; Urinary incontinence; Pelvic floor muscle training; Transcutaneous tibial nerve stimulation

Outcome Measures

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).

  Baseline (T0) and Week 12 (T1)

Secondary Outcomes (11)

• 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)

Study Arms (2)

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.

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.

Device: Sham Transcutaneous Tibial Nerve Stimulation (TTNS); Behavioral: Pelvic Floor Muscle Training (PFMT)

Interventions

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.

Active TTNS Group

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.

Sham TTNS Group

Pelvic Floor Muscle Training (PFMT) BEHAVIORAL

A 12-week progressive home-based pelvic floor muscle training program with graded contraction/relaxation durations and postural progression.

Active TTNS Group; Sham TTNS Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Pamukkale, Denizli, 20160, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 39760411 BACKGROUND

• Yamanishi 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.

  PMID: 20850831 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Necmettin Yıldız, MD

  Pamukkale University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yusuf YOLCU, MD

CONTACT

+90 258 296 16 02; dr.yusufyolcu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: August 3, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 3, 2026

Record last verified: 2026-07

Locations

TU (1)