Actively Recruiting
Effects of Extracorporeal Shockwave Therapy Versus Pulsed Electromagnetic Field Therapy in Females With Sexual Dysfunction: a Randomized Controlled Trial
Led by Benha University · Updated on 2026-05-18
90
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
B
Benha University
Lead Sponsor
B
Beni-Suef University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for female sexual dysfunction (FSD), a condition involving physical and psychological factors that affect sexual function, including pelvic floor issues and blood flow problems. This trial compares three approaches: extracorporeal shockwave therapy (ESWT) combined with pelvic floor muscle training (PFMT), pulsed electromagnetic field stimulation (PEMF) combined with PFMT, and PFMT alone. The goal is to see which method improves sexual function in women with FSD. The study design is a randomized controlled trial with assessor blinding to reduce bias. Ninety women with FSD will be randomly assigned to one of three groups. The ESWT group will receive weekly low-intensity shockwave therapy sessions targeting the pelvic floor for eight weeks, along with supervised PFMT three times per week. The PEMF group will have pulsed electromagnetic stimulation three times weekly for eight weeks plus the same PFMT program. The control group will perform only the supervised PFMT. The PFMT involves exercises done three times weekly, focusing on contracting pelvic floor muscles under guidance, with additional home exercises. Participants will be assessed at the start, after eight weeks of treatment, and at sixteen weeks, including follow-up. Researchers will measure sexual function using the Female Sexual Function Index (FSFI) total score, sexual quality of life, and pelvic floor muscle strength. Assessments will include questionnaires and muscle strength tests. The study lasts sixteen weeks in total, with eight weeks of intervention and eight weeks of follow-up, to monitor changes and treatment effects while ensuring safety and adherence.
CONDITIONS
Brief Title
Effects of Extracorporeal Shockwave Therapy Versus Pulsed Electromagnetic Field Therapy in Females With Sexual Dysfunction.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 20 to 50 years with female sexual dysfunction and FSFI score below 26.55
- Premenopausal women in a stable sexual relationship for at least 6 months
- Sexually active during the previous month
- Symptoms lasting at least 3 months before enrollment
- Able to understand study procedures and provide written informed consent
- Willing to avoid starting new treatments for sexual dysfunction during the study
You will not qualify if you...
- Pregnancy or planned pregnancy during the study period
- Pelvic surgery within the last 6 months
- Active pelvic inflammatory disease, genital infection, or unexplained vaginal bleeding
- Neurological disorders affecting pelvic floor or sexual function
- Severe pelvic organ prolapse, severe urinary incontinence, or significant pelvic abnormalities
- Current hormonal therapy or medications affecting sexual function such as antidepressants or antipsychotics
- Severe psychiatric disorders or cognitive impairment
- Menopause or perimenopausal status
- Uncontrolled systemic diseases like diabetes, hypertension, cardiovascular disease, or thyroid disorders
- History of malignancy, pelvic radiation, or severe chronic pelvic pain
- Contraindications to ESWT or PEMF including pacemakers, coagulation disorders, epilepsy, or metal implants in the pelvic area
- Participation in another clinical trial or physiotherapy for sexual dysfunction within the last 3 months
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive one of three interventions over 8 weeks: weekly low-intensity extracorporeal shockwave therapy with pelvic floor muscle training three times weekly; pulsed electromagnetic field stimulation three times weekly combined with pelvic floor muscle training three times weekly; or pelvic floor muscle training alone three times weekly.
Weekly or thrice weekly visits depending on the assigned therapy
Duration - 8 weeks
Participants continue to be assessed after the treatment period to evaluate outcomes related to sexual function and pelvic floor muscle strength.
Visits at Week 8 and Week 16
Trial Site Locations
Total: 1 location
1
Outpatient clinic, faculty of Physical Therapy, Beni Suef University
Banī Suwayf, Egypt
Actively Recruiting
Research Team
M
Mahmoud Hamada Mohamed Associate Professor, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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