PEMF vs Laser for Stress Urinary Incontinence

NCT06137326 | Completed

• 1 other identifier: PEMF-LAS-2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Severity Index for urinary incontinence

  Baseline and 8 weeks

• Change in ICIQ-UI SF score

  Baseline and 8 weeks

Study Arms (2)

Pulsed Electromagnetic Field Therapy

EXPERIMENTAL

Device: Pulsed Electromagnetic Field Therapy

Laser Acupuncture

ACTIVE COMPARATOR

Device: Laser Acupuncture

Interventions

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.

Pulsed Electromagnetic Field Therapy

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.

Laser Acupuncture

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ahram Canadian University: lead

Study Sites (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, 3221405, Egypt

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mahmoud Hamada, Ph.D

  Faculty of Physical Therapy, Ahram Canadian University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Electromyography lab

Model Details: This is a parallel group randomized controlled trial with two arms receiving different interventions.

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 18, 2023
• Study Start: November 17, 2023
• Primary Completion: January 21, 2025
• Study Completion: January 21, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

EG (1)