Effects of Extracorporeal Shockwave Therapy Versus Pulsed Electromagnetic Field Therapy in Females With Sexual Dysfunction.

NCT07584174 | Recruiting

• 1 other identifier: ESWT VS PEMF in FSD 2026
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Sexual Dysfunction (FSD); Pelvic Floor Muscle Training; Shock Wave; Pulsed Electromagnetic Therapy

Keywords

extracorporeal shock wave therapy; pulsed electromagnetic filed therapy; pelvic floor muscles training; females sexual dysfunction

Outcome Measures

Primary Outcomes (1)

• Female Sexual Function Index (FSFI) Total Score

  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.

  Baseline, Week 8. Week 16

Secondary Outcomes (2)

• Sexual Quality of Life Scale

  Baseline, week 8, and week 16

• Pelvic floor muscle strength

  Baseline, week 6 and week 16

Study Arms (3)

ESWT + PFMT

EXPERIMENTAL

Participants will receive low-intensity extracorporeal shockwave therapy and participants will perform a standardized pelvic floor muscle training program

Other: low-intensity extracorporeal shockwave therapy; Other: Pelvic floor muscle training

PEMF + PFMT

ACTIVE COMPARATOR

Participants will receive pulsed electromagnetic stimulation combined with the same standardized pelvic floor muscle training program

Other: Pulsed electromagnetic field stimulation; Other: Pelvic floor muscle training

PFMT (Control)

OTHER

Participants will receive a standardized pelvic floor muscle training program

Other: Pelvic floor muscle training

Interventions

low-intensity extracorporeal shockwave therapy OTHER

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

ESWT + PFMT

Pulsed electromagnetic field stimulation OTHER

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.

PEMF + PFMT

Pelvic floor muscle training OTHER

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

ESWT + PFMT; PEMF + PFMT; PFMT (Control)

Eligibility Criteria

• Age: 20 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Premenopausal women in a stable sexual relationship for at least 6 months and sexually active during the previous month.
• Symptoms persisting for at least 3 months before enrollment.
• Ability to understand study procedures and provide written informed consent.
• Willingness to refrain from initiating any additional treatment for sexual dysfunction during the study period

You may not qualify if:

• Pregnancy or planned pregnancy during the study period.
• Pelvic surgery within the previous 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 anatomical abnormalities.
• Current hormonal therapy or use of medications known to affect sexual function, including antidepressants or antipsychotics.
• Severe psychiatric disorders or cognitive impairment limiting participation.
• Menopause or perimenopausal status.
• Uncontrolled systemic diseases such as diabetes mellitus, hypertension, cardiovascular disease, or thyroid disorders.
• Presence of malignancy, pelvic radiation history, or severe chronic pelvic pain disorders.
• Contraindications to ESWT or PEMF including cardiac pacemakers or implanted electronic devices, coagulation disorders, anticoagulant therapy, epilepsy, or metal implants in the pelvic region.
• Current participation in another clinical trial or receipt of physiotherapy for sexual dysfunction within the previous 3 months.

Sponsors & Collaborators

• Benha University: lead
• Beni-Suef University: collaborator

Study Sites (1)

Outpatient clinic, faculty of Physical Therapy, Beni Suef University

Banī Suwayf, Egypt

RECRUITING

Central Study Contacts

Mahmoud Hamada Mohamed Associate Professor, Ph.D

CONTACT

01096968910; mahmoud.mohamed@fpt.bu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physical Therapy

Model Details: Interventional study, randomized allocation, parallel assignment, three arms, assessor-blinded, treatment purpose, 1:1:1 allocation ratio.

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 13, 2026
• Study Start: May 14, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

EG (1)