NCT07319247

Laser Therapy and Pelvic Floor Muscle Training for Stress Urinary Incontinence

The Effect of High-frequency Laser Therapy and Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence: A Plasebo Randomized Controlled Trial

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Necmettin Erbakan University · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 10 weeks under the supervision of a physiotherapist. PFMT will be administered with biofeedback. HFMT will be applied to six points in the perineal region (2 minutes per point). 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).

Conditions

• Urinary Incontinence (UI)
• Laser Therapy
• Stress Urinary Incontinence (SUI)
• Pelvic Floor Muscle Exercise

Interventions

Type	Name	Description
BEHAVIORAL	PFME+Laser Therapy	PFMT, patients are taught pelvic floor exercises, which involve slow and fast muscle contractions that train both Type 1 and Type 2 muscle fibers, using vaginal palpation. During fast contractions, patients are asked to quickly contract and relax their pelvic floor muscles. The image of "turning the faucet off and on" is used to help patients better understand this exercise. During slow contractions, patients are asked to slowly tighten their pelvic floor muscles, hold them for 10 seconds, and then slowly relax them. One set of pelvic floor muscle exercises consists of 10 fast contractions and 10 slow contractions. According to this program, pelvic floor exercises are performed in weeks 1-2, in weeks 3-4, in weeks 5-6, in weeks 8-12, and in weeks 10. Laser application is applied to 6 points in the perineal area. Continue and biostimulatory mode, intensity 6W, energy density 120J/cm2. Application time is 2 minutes for each point, and a total of 6 sessions are applied 3 time
OTHER	Plasebo Laser	The laser device will be held on 6 points in the perineal area for the same period of time without being plugged in.
BEHAVIORAL	PFMT Group	In this training, patients are taught pelvic floor exercises, which involve slow and fast muscle contractions that train both Type 1 and Type 2 muscle fibers, using vaginal palpation. During fast contractions, patients are asked to quickly contract and relax their pelvic floor muscles. The image of "turning the faucet off and on" is used to help patients better understand this exercise. During slow contractions, patients are asked to slowly tighten their pelvic floor muscles, hold them for 10 seconds, and then slowly relax them. One set of pelvic floor muscle exercises consists of 10 fast contractions and 10 slow contractions. According to this program, pelvic floor exercises are performed in weeks 1-2, 2 sets in weeks 3-4, 4 sets in weeks 5-6, 8 sets in weeks 7-8, and 10 sets in weeks 8-12. Assessments will be conducted twice, baseline and post treatment (at 10 week).

Timeline

• Start date: 2025-12-09
• Primary completion: 2026-02-21
• Completion: 2026-04-13
• First posted: 2026-01-06
• Last updated: 2026-04-14

Locations

1 site across 1 country: Turkey (Türkiye)