Stress Urinary IncontinenceNCT06137326
PEMF vs Laser for Stress Urinary Incontinence
A study testing Pulsed Electromagnetic Field Therapy and Laser Acupuncture in people with Stress Urinary Incontinence, run by Ahram Canadian University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Pulsed Electromagnetic Field Therapy and Laser Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Nov 2023to 21 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult females aged 18-65 years with stress urinary incontinence
- Able to comply with study procedures and schedule
Who cannot join
- Prior pelvic floor surgery
- Pregnancy
- Active urinary tract infection
- Pelvic organ prolapse >Stage 2
- Neurologic disorder affecting urinary function
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
Al Ḩayy Ath Thāmin, Giza Governorate, 3221405
About this study
Official title: Efficacy of Pulsed Electromagnetic Field Therapy Versus Laser Acupuncture on Female Stress Urinary Incontinence: A Randomized Controlled Trial
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
- Being tested
- Pulsed Electromagnetic Field Therapy, Laser Acupuncture
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Electromagnetic Field TherapyDevice
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 AcupunctureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Pulsed Electromagnetic Field Therapy | Experimental | Not described Receives: Device: Pulsed Electromagnetic Field Therapy |
| Laser Acupuncture | Active comparator | Not described Receives: Device: Laser Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 8 weeks
Secondary outcomes (2)
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.
Measured: Baseline and 8 weeks
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.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start17 Nov 2023
- Primary completion21 Jan 2025
- Study completion21 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a parallel group randomized controlled trial with two arms receiving different interventions.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Magdy ElMeligie, Ahram Canadian University
- Investigators
- Mahmoud Hamada, Ph.D, Study chair, Faculty of Physical Therapy, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06137326
- Sponsor's protocol ID
- PEMF-LAS-2023
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2023
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pulsed Electromagnetic Field Therapy Versus Laser Acupuncture on Female Stress Urinary Incontinence: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06137326
- Acronym / sponsor ID
- PEMF-LAS-2023
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 21 Jan 2025 (actual)
- Study completion
- 21 Jan 2025 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This is a parallel group randomized controlled trial with two arms receiving different interventions.
| Arm | Type | Receives |
|---|---|---|
| Pulsed Electromagnetic Field Therapy | Experimental | Device: Pulsed Electromagnetic Field Therapy |
| Laser Acupuncture | Active comparator | Device: Laser Acupuncture |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult females aged 18-65 years with stress urinary incontinence
- Able to comply with study procedures and schedule
Key exclusion criteria (5 listed)
- Prior pelvic floor surgery
- Pregnancy
- Active urinary tract infection
- Pelvic organ prolapse >Stage 2
- Neurologic disorder affecting urinary function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed Electromagnetic Field TherapyParticipants 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. | Device | Pulsed Electromagnetic Field Therapy |
| Laser AcupunctureParticipants 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. | Device | Laser Acupuncture |
Primary outcome
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.
2 secondary outcomes
Change in Severity Index for urinary incontinence
Time frame: Baseline and 8 weeks
Change in ICIQ-UI SF score
Time frame: Baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Stress Urinary Incontinence
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy
Not yet recruiting
Feasibility of Resisted Expiratory Muscle Training for Females Assigned at Birth With Stress Urinary Incontinence: A Pilot Study
Stress Urinary Incontinence
RecruitingPhase 2
Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer
Urinary Urge Incontinence, Stress Urinary Incontinence
RecruitingPhase 4
Prophylactic Antibiotics for Outpatient Urethral Bulking
Urinary Tract Infections, Stress Urinary Incontinence
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release in Bipolar Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Hamada, Ph.D study chair
Faculty of Physical Therapy, Ahram Canadian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Electromagnetic Field Therapy and Laser Acupuncture in people with Stress Urinary Incontinence, run by Ahram Canadian University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pelvic floor muscle strength (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.