Clinical Trial

Laser Therapy and Pelvic Floor Muscle Training for Stress Urinary Incontinence

Enrolling by Invitation
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Summary
The aim of this study was to investigate the effects of Pelvic Floor Muscle Training (PFMT) in addition to high-intensity laser therapy (HILT) on pelvic floor dysfunction, sexual dysfunction, and quality of life in women with stress urinary incontinence. Women with SUI will be randomly assigned to PFMT (Group I), Laser + PFMT (Group II), and placebo laser (Group III). PFMT will be administered twice weekly for 12 weeks under the supervision of a physiotherapist. PFMT will be administered with biofeedback. HILT will be applied to six points in the perineal region . The intensity will be 6W, the energy density will be 120J/cm2, and three sessions will be administered weekly for a total of six sessions. Women included in the study will be evaluated twice, at the beginning and at the end of the treatment, with the Incontinence Quality of Life Scale (I-QOL), Incontinence Severity Index (ISI), Female Sexual Function Scale-(FSFI), and Global Pelvic Floor Impact Questionnaire (GPTRA).
Protocol Amendment History 3 changes
minor Completion pushed: 2026-06-30 -> 2026-07-30 2026-07-15
minor Completion pushed: 2026-05-30 -> 2026-06-30 2026-06-30
minor Completion pushed: 2026-04-13 -> 2026-05-30 2026-05-12
Trial Details
NCT Number NCT07319247
Lead Sponsor Necmettin Erbakan University
Conditions Urinary Incontinence (UI), Laser Therapy, Stress Urinary Incontinence (SUI), Pelvic Floor Muscle Exercise
Enrollment 36 participants
Start Date 2025-12-09
Primary Completion 2026-02-21 (estimated)
Study Completion 2026-07-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-14