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

14 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

90

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Egipt
      • Banī Suwayf, Egipt
        • Rekrutacyjny
        • Outpatient clinic, faculty of Physical Therapy, Beni Suef University
        • Kontakt:
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: ESWT + PFMT
Participants will receive low-intensity extracorporeal shockwave therapy and participants will perform a standardized pelvic floor muscle training program
Inny: 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
Inny: 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
Aktywny komparator: PEMF + PFMT
Participants will receive pulsed electromagnetic stimulation combined with the same standardized pelvic floor muscle training program
Inny: 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
Inny: 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.
Inny: PFMT (Control)
Participants will receive a standardized pelvic floor muscle training program
Inny: 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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Female Sexual Function Index (FSFI) Total Score
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Sexual Quality of Life Scale
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Benha University

Współpracownicy

Beni-Suef University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

14 maja 2026

Zakończenie podstawowe (Szacowany)

15 grudnia 2026

Ukończenie studiów (Szacowany)

15 stycznia 2027

Daty rejestracji na studia

Pierwszy przesłany

7 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

7 maja 2026

Pierwszy wysłany (Rzeczywisty)

13 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

18 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

14 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • ESWT VS PEMF in FSD 2026

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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