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

14 maj 2026 uppdaterad av: Mahmoud Hamada Mohamed, Benha University

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

90

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: ESWT + PFMT
Participants will receive low-intensity extracorporeal shockwave therapy and participants will perform a standardized pelvic floor muscle training program
Övrig: low-intensity extracorporeal shockwave therapy
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
Övrig: Pelvic 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
Aktiv komparator: PEMF + PFMT
Participants will receive pulsed electromagnetic stimulation combined with the same standardized pelvic floor muscle training program
Övrig: Pelvic 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
Övrig: Pulsed electromagnetic field stimulation
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.
Övrig: PFMT (Control)
Participants will receive a standardized pelvic floor muscle training program
Övrig: Pelvic 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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Female Sexual Function Index (FSFI) Total Score
Tidsram: 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.
Baseline, Week 8. Week 16

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Sexual Quality of Life Scale
Tidsram: 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.
Baseline, week 8, and week 16
Pelvic floor muscle strength
Tidsram: 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.
Baseline, week 6 and week 16

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Benha University

Samarbetspartners

Beni-Suef University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

14 maj 2026

Primärt slutförande (Beräknad)

15 december 2026

Avslutad studie (Beräknad)

15 januari 2027

Studieregistreringsdatum

Först inskickad

7 maj 2026

Först inskickad som uppfyllde QC-kriterierna

7 maj 2026

Första postat (Faktisk)

13 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • ESWT VS PEMF in FSD 2026

Plan för individuella deltagardata (IPD)

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