PEMF vs Laser for Stress Urinary Incontinence

Sponsor
Ahram Canadian University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06137326
Collaborator
(none)
60
1
2
8.4
7.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Pulsed Electromagnetic Field Therapy
  • Device: Laser Acupuncture
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This is a parallel group randomized controlled trial with two arms receiving different interventions.This is a parallel group randomized controlled trial with two arms receiving different interventions.
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Efficacy of Pulsed Electromagnetic Field Therapy Versus Laser Acupuncture on Female Stress Urinary Incontinence: A Randomized Controlled Trial
Anticipated Study Start Date :
Nov 17, 2023
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jul 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pulsed Electromagnetic Field Therapy

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.

Active Comparator: Laser Acupuncture

Device: 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Outpatient clinic of faculty of physical therapy, Ahram Canadian University Al Ḩayy Ath Thāmin Giza Egypt 3221405

Sponsors and Collaborators

  • Ahram Canadian University

Investigators

  • Study Chair: Mahmoud Hamada, Ph.D, Faculty of Physical Therapy, Ahram Canadian University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohamed Magdy ElMeligie, Director of Electromyography lab, Ahram Canadian University
ClinicalTrials.gov Identifier:
NCT06137326
Other Study ID Numbers:
  • PEMF-LAS-2023
First Posted:
Nov 18, 2023
Last Update Posted:
Nov 18, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2023