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

Официальное название

Effects of Extracorporeal Shockwave Therapy Versus Pulsed Electromagnetic Field Therapy in Females With Sexual Dysfunction: a Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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 inte
• Другое 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.
• Другое 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 p

Первичные конечные точки

• Female Sexual Function Index (FSFI) Total Score [Срок оценки: Baseline, Week 8. Week 16]

Вторичные конечные точки (2)

• Sexual Quality of Life Scale [Срок оценки: Baseline, week 8, and week 16]
• Pelvic floor muscle strength [Срок оценки: Baseline, week 6 and week 16]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Outpatient clinic, faculty of Physical Therapy, Beni Suef University — Banī Suwayf

Идентификаторы

NCT: NCT07584174 · ESWT VS PEMF in FSD 2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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