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OpenTrials
Completed

NCT Number: NCT06137326

PEMF vs Laser for Stress Urinary Incontinence

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, 3221405, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulsed Electromagnetic Field Therapy

Device

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

Device

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.

Primary outcomes

  1. Change in pelvic floor muscle strength

    Time frame: 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 outcomes

  1. Change in Severity Index for urinary incontinence

    Time frame: 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.

  2. Change in ICIQ-UI SF score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ahram Canadian University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2023
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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