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Transcutaneous Tibial Nerve Stimulation for Urinary Incontinence After Radical Prostatectomy

NCT07742176 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2026-08-06

No results posted yet for this study

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

Interventions

DEVICE

Active 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.

DEVICE

Sham Transcutaneous Tibial Nerve Stimulation (TTNS)

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.

BEHAVIORAL

Pelvic Floor Muscle Training (PFMT)

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

Sponsors & Collaborators

  • Pamukkale University

    lead OTHER

Principal Investigators

  • Necmettin Yıldız, MD · Pamukkale University Faculty of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07742176 on ClinicalTrials.gov