Female Sexual Dysfunction (FSD)NCT07584174
Effects of Extracorporeal Shockwave Therapy Versus Pulsed Electromagnetic Field Therapy in Females With Sexual Dysfunction.
A study testing low-intensity extracorporeal shockwave therapy, Pulsed electromagnetic field stimulation and Pelvic floor muscle training in people with Female Sexual Dysfunction (FSD) and Pelvic Floor Muscle Training, run by Benha University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Female Sexual Dysfunction (FSD), Pelvic Floor Muscle Training, Shock Wave
- What is being tested?
- low-intensity extracorporeal shockwave therapy, Pulsed electromagnetic field stimulation and Pelvic floor muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 14 May 2026to 15 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient clinic, faculty of Physical Therapy, Beni Suef University
Banī Suwayf
Marwa Elsayed Mohamed Lecturer, Ph.D, 01141825442, Marwa.elsayed@pt.bsu.edu.eg
Marwa Elsayed Mohamed Lecturer, Ph.D, Marwa.elsayed@pt.bsu.edu.eg
About this study
Official title: Effects of Extracorporeal Shockwave Therapy Versus Pulsed Electromagnetic Field Therapy in Females With Sexual Dysfunction: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Female Sexual Dysfunction (FSD), Pelvic Floor Muscle Training, Shock Wave, Pulsed Electromagnetic Therapy
- Being tested
- low-intensity extracorporeal shockwave therapy, Pulsed electromagnetic field stimulation, Pelvic floor muscle training
- Keywords
- extracorporeal shock wave therapy, pulsed electromagnetic filed therapy, pelvic floor muscles training, females sexual dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-intensity extracorporeal shockwave therapyOther
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 stimulationOther
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.
Pelvic floor muscle trainingOther
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
| Study group | Role | What they receive |
|---|---|---|
| ESWT + PFMT | Experimental | Participants will receive low-intensity extracorporeal shockwave therapy and participants will perform a standardized pelvic floor muscle training program Receives: 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 Receives: Other: Pulsed electromagnetic field stimulation; Other: Pelvic floor muscle training |
| PFMT (Control) | Other | Participants will receive a standardized pelvic floor muscle training program Receives: Other: Pelvic floor muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 8. Week 16
Secondary outcomes (2)
Sexual Quality of Life Scale
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.
Measured: Baseline, week 8, and week 16
Pelvic floor muscle strength
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.
Measured: Baseline, week 6 and week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start14 May 2026
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Sexual Dysfunction (FSD)Studies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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
- Interventional study, randomized allocation, parallel assignment, three arms, assessor-blinded, treatment purpose, 1:1:1 allocation ratio.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Collaborators
- Beni-Suef University
- Responsible party
- Principal investigator, Mahmoud Hamada Mohamed, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07584174
- Sponsor's protocol ID
- ESWT VS PEMF in FSD 2026
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 18 May 2026
- 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 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Extracorporeal Shockwave Therapy Versus Pulsed Electromagnetic Field Therapy in Females With Sexual Dysfunction: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07584174
- Acronym / sponsor ID
- ESWT VS PEMF in FSD 2026
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Collaborators
- Beni-Suef University
- Study start
- 14 May 2026 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 13 May 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Interventional study, randomized allocation, parallel assignment, three arms, assessor-blinded, treatment purpose, 1:1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| ESWT + PFMT | Experimental | Other: low-intensity extracorporeal shockwave therapy, Other: Pelvic floor muscle trainingParticipants will receive low-intensity extracorporeal shockwave therapy and participants will perform a standardized pelvic floor muscle training program |
| PEMF + PFMT | Active comparator | Other: Pulsed electromagnetic field stimulation, Other: Pelvic floor muscle trainingParticipants will receive pulsed electromagnetic stimulation combined with the same standardized pelvic floor muscle training program |
| PFMT (Control) | Other | Other: Pelvic floor muscle trainingParticipants will receive a standardized pelvic floor muscle training program |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
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 |
|---|---|---|
| low-intensity extracorporeal shockwave therapyExtracorporeal 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 | Other | ESWT + PFMT |
| Pulsed electromagnetic field stimulationPulsed 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. | Other | PEMF + PFMT |
| Pelvic floor muscle trainingpelvic 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 | Other | ESWT + PFMT, PEMF + PFMT, PFMT (Control) |
Primary outcome
Female Sexual Function Index (FSFI) Total Score
Time frame: 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.
2 secondary outcomes
Sexual Quality of Life Scale
Time frame: Baseline, week 8, and week 16
Pelvic floor muscle strength
Time frame: Baseline, week 6 and week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low-intensity extracorporeal shockwave therapy, Pulsed electromagnetic field stimulation and Pelvic floor muscle training in people with Female Sexual Dysfunction (FSD) and Pelvic Floor Muscle Training, run by Benha 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 5 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 18 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Hamada Mohamed Associate Professor, Ph.D (01096968910, mahmoud.mohamed@fpt.bu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Female Sexual Function Index (FSFI) Total Score (time frame: Baseline, Week 8. Week 16). 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 18 May 2026.