Female Sexual Dysfunction (FSD), Pelvic Floor Muscle Training, Pulsed Electromagnetic Therapy, Shock Wave
Conditions
Keywords
extracorporeal shock wave therapy, pulsed electromagnetic filed therapy, pelvic floor muscles training, females sexual dysfunction
Brief summary
This is a prospective, three-arm, parallel-group, assessor-blinded randomized controlled trial designed to compare the effectiveness of extracorporeal shockwave therapy (ESWT) combined with pelvic floor muscle training (PFMT), pulsed electromagnetic field stimulation (PEMF) combined with PFMT, and PFMT alone in Females with sexual dysfunction. Participants will be randomly allocated in a 1:1:1 ratio, and the study duration is 16 weeks, including an 8-week intervention period and an 8-week follow-up period.
Detailed description
Female sexual dysfunction is a multifactorial condition involving physiological, vascular, neuromuscular, and psychosocial components, and pelvic floor dysfunction and impaired genital blood flow are recognized contributing factors. Therefore, this trial integrates both neuromuscular rehabilitation and non-invasive energy-based modalities to target different underlying mechanisms of FSD. A total of 90 women diagnosed with FSD based on a Female Sexual Function Index (FSFI) score \< 26.55 will be recruited and randomly assigned in a 1:1:1 ratio to one of three groups. The ESWT + PFMT group will receive low-intensity radial extracorporeal shockwave therapy once weekly for 8 weeks, applied to the perineum and pelvic floor trigger points, in addition to a standardized pelvic floor muscle training program performed three times weekly under supervision. The PEMF + PFMT group will receive pulsed electromagnetic field stimulation three times weekly for 8 weeks, combined with the same standardized PFMT protocol. The PFMT-only group will perform identical supervised pelvic floor muscle training without adjunct device-based therapy. Randomization will be performed using a computer-generated sequence with block randomization, and allocation will be ensured using sealed opaque envelopes. Outcome assessors will be blinded to group allocation to reduce assessment bias.
Interventions
Extracorporeal shockwave therapy will be delivered using a low-intensity radial shockwave device, administered once weekly for 8 weeks, with each session delivering 1500-2000 shockwave pulses at an energy flux density of 0.05-0.10 mJ/mm² and a frequency of 5-8 Hz. The application will target the perineum and pelvic floor trigger points using a standardized treatment probe with appropriate coupling gel to ensure optimal energy transmission. Each session will last approximately 7 minutes, and intensity will be adjusted based on patient tolerance without exceeding the recommended energy threshold for soft tissue application
Pulsed electromagnetic field stimulation (PEMF) will be applied to the pelvic floor region for 20-minute sessions, three times weekly day after day for 8 consecutive weeks. Stimulation parameters will include a frequency of 10 Hz, magnetic field intensity of 200 μT, and pulse duration of 250 μs. Treatment sessions will be administered under therapist supervision with participants positioned comfortably in supine crook-lying.
OTHERPelvic floor muscle training
pelvic floor exercises will be performed for 45 minutes per day, three days per week, over an eight-week period. Prior to beginning participant will be directed to void the bladder and be supine lying with flexed knees and mildly abducted hips. She was then will be guided to contract the PFMs maximally, holding each contraction for 10 seconds. This will be performed 15 times with a 10-second rest interval within contractions. Each session will be consisted of three exercise sets, with each set performed for 15 minutes. Home exercises were prescribed twice daily, providing a total of 45 minutes of training each day
Sponsors
Benha University
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors will be blinded
Intervention model description
Interventional study, randomized allocation, parallel assignment, three arms, assessor-blinded, treatment purpose, 1:1:1 allocation ratio.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Female participants aged 20-50 years diagnosed with female sexual dysfunction (FSFI score \<26.55), reporting symptoms of reduced sexual desire, arousal dysfunction, orgasmic dysfunction, or dyspareunia. 2. Premenopausal women in a stable sexual relationship for at least 6 months and sexually active during the previous month. 3. Symptoms persisting for at least 3 months before enrollment. 4. Ability to understand study procedures and provide written informed consent. 5. Willingness to refrain from initiating any additional treatment for sexual dysfunction during the study period
Exclusion criteria
1. Pregnancy or planned pregnancy during the study period. 2. Pelvic surgery within the previous 6 months. 3. Active pelvic inflammatory disease, genital infection, or unexplained vaginal bleeding. 4. Neurological disorders affecting pelvic floor or sexual function. 5. Severe pelvic organ prolapse, severe urinary incontinence, or significant pelvic anatomical abnormalities. 6. Current hormonal therapy or use of medications known to affect sexual function, including antidepressants or antipsychotics. 7. Severe psychiatric disorders or cognitive impairment limiting participation. 8. Menopause or perimenopausal status. 9. Uncontrolled systemic diseases such as diabetes mellitus, hypertension, cardiovascular disease, or thyroid disorders. 10. Presence of malignancy, pelvic radiation history, or severe chronic pelvic pain disorders. 11. Contraindications to ESWT or PEMF including cardiac pacemakers or implanted electronic devices, coagulation disorders, anticoagulant therapy, epilepsy, or metal implants in the pelvic region. 12. Current participation in another clinical trial or receipt of physiotherapy for sexual dysfunction within the previous 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Female Sexual Function Index (FSFI) Total Score | Baseline, Week 8. Week 16 | Female sexual function will be assessed using the Female Sexual Function Index (FSFI), a validated self-reported 19-item questionnaire designed to evaluate six domains of female sexual function, including desire, arousal, lubrication, orgasm, satisfaction, and pain. Individual domain scores are calculated and summed to obtain a total score ranging from 2 to 36, with higher scores indicating better sexual function, while scores below 26.55 are considered indicative of female sexual dysfunction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sexual Quality of Life Scale | Baseline, week 8, and week 16 | Sexual quality of life will be assessed using the Sexual Quality of Life-Female Questionnaire (SQOL-F), a validated self-administered questionnaire designed to evaluate the impact of female sexual dysfunction on psychosocial well-being and intimate relationships. The questionnaire consists of 18 items covering domains of sexual confidence, emotional well-being, relationship satisfaction, self-esteem, and psychosexual functioning. Each item is scored on a 6-point Likert scale, and the total score is transformed to a 0-100 scale, with higher scores indicating better sexual quality of life. |
| Pelvic floor muscle strength | Baseline, week 6 and week 16 | Pelvic floor muscle strength will be objectively assessed before and after the intervention using the XFT-0010 Pelvic Floor Assessment System. The system consists of an appropriately sized intravaginal pressure probe connected to the main recording unit via a flexible catheter, enabling quantitative measurement of pelvic floor muscle contraction strength. Participants will be assessed in the crook-lying position under standardized conditions and instructed to perform three maximal voluntary pelvic floor muscle contractions, each separated by a standardized rest interval to minimize fatigue. The highest recorded contraction value will be used for statistical analysis. |
Countries
Egypt
Contacts
CONTACTMahmoud Hamada Mohamed Associate Professor, Ph.D
Outcome results
None listed