PEMF vs Laser for Stress Urinary Incontinence

Stress Urinary Incontinence Clinical Trial

Official title:

Efficacy of Pulsed Electromagnetic Field Therapy Versus Laser Acupuncture on Female Stress Urinary Incontinence: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06137326
• Other study ID #: PEMF-LAS-2023
• Status: Recruiting
• Phase: N/A
• Start date: November 17, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: November 2023
• Source: Ahram Canadian University
• Contact: Mohamed ElMeligie, Ph.D
• Phone: 01159880001
• Email: mmahm1989[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Pulsed Electromagnetic Field Therapy
Participants in this arm will receive pulsed electromagnetic field (PEMF) therapy to the pelvic floor area along with pelvic floor muscle training. The PEMF device generates a pulsed magnetic field with the following parameters: frequency 10 Hz, intensity 200 µT, pulse duration 250 µs. It will be applied over the pelvic floor for 20 minutes per session, 5 days per week for 8 weeks.
• Laser Acupuncture
Participants in this arm will receive low-level laser acupuncture to pelvic floor trigger points along with pelvic floor muscle training. A continuous wave 810 nm diode laser will be used at 100 mW power and 0.5 J/point, delivered to 6 pelvic floor acupoints bilaterally (12 points total) for 15 seconds per point. Acupuncture will be performed 3 days per week for 8 weeks.

Locations

Country	Name	City	State
Egypt	Outpatient clinic of faculty of physical therapy, Ahram Canadian University	Al ?ayy Ath Thamin	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Ahram Canadian University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pelvic floor muscle strength	elvic floor muscle strength will be assessed using a calibrated perineometer device that measures vaginal squeeze pressure. Strength will be recorded in cm H2O.	Baseline and 8 weeks
Secondary	Change in Severity Index for urinary incontinence	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.	Baseline and 8 weeks
Secondary	Change in ICIQ-UI SF score	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.	Baseline and 8 weeks