PEMF vs Laser for Stress Urinary Incontinence

Not Applicable

Recruiting

• Conditions: Stress Urinary Incontinence
• Interventions: Device: Pulsed Electromagnetic Field Therapy; Device: Laser Acupuncture

• Registration Number: NCT06137326
• Lead Sponsor: Ahram Canadian University

Brief Summary

Stress urinary incontinence, or involuntary urine leakage during activities like coughing, laughing, or exercise, is a common condition that impacts quality of life for many women. Pelvic floor muscle training is often used to treat stress incontinence, but additional therapies may enhance outcomes. This randomized controlled trial will compare two physical therapy modalities, pulsed electromagnetic field (PEMF) therapy versus laser acupuncture, along with pelvic floor training for improving stress urinary incontinence in 60 adult women. The study will evaluate their effects on pelvic floor muscle strength, severity of urine leakage, and quality of life. We hypothesize that PEMF and laser acupuncture will both improve stress incontinence, but PEMF will be more effective based on greater pelvic floor stimulation. The study aims to provide evidence on these physical therapy options so that optimized treatment plans can be developed for women with stress urinary incontinence.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-14
• Study First Submitted QC: 2023-11-14
• Last Update Submitted: 2023-11-14
• Study Start: 2023-11-17
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18
• Primary Completion: 2024-06-30
• Study Completion: 2024-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Adult females aged 18-65 years with stress urinary incontinence
• Able to comply with study procedures and schedule

Exclusion Criteria

• Prior pelvic floor surgery
• Pregnancy
• Active urinary tract infection
• Pelvic organ prolapse >Stage 2
• Neurologic disorder affecting urinary function

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulsed Electromagnetic Field Therapy	Pulsed Electromagnetic Field Therapy	-
Laser Acupuncture	Laser Acupuncture	-

Primary Outcome Measures

Name	Time	Method
Change in pelvic floor muscle strength	Baseline and 8 weeks	elvic floor muscle strength will be assessed using a calibrated perineometer device that measures vaginal squeeze pressure. Strength will be recorded in cm H2O.

Secondary Outcome Measures

Name	Time	Method
Change in ICIQ-UI SF score	Baseline and 8 weeks	The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is a validated quality of life questionnaire for urinary incontinence. It contains 3 scored items, with total score range of 0-21. Higher scores denote greater impact on QOL.
Change in Severity Index for urinary incontinence	Baseline and 8 weeks	Severity of urine leakage will be scored using the Severity Index (SI), a validated index that rates leakage frequency and volume on a 0-20 point scale. Higher scores indicate greater severity.

Trial Locations

Locations (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University; 🇪🇬 Al Ḩayy Ath Thāmin, Giza, Egypt