Effects of Extracorporeal Shockwave Therapy Versus Pulsed Electromagnetic Field Therapy in Females With Sexual Dysfunction.
14 mai 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
90
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Mahmoud Hamada Mohamed Associate Professor, Ph.D
- Numéro de téléphone: 01096968910
- E-mail: mahmoud.mohamed@fpt.bu.edu.eg
Lieux d'étude
-
-
-
Banī Suwayf, Egypte
- Recrutement
- Outpatient clinic, faculty of Physical Therapy, Beni Suef University
-
Contact:
- Marwa Elsayed Mohamed Lecturer, Ph.D
- Numéro de téléphone: 01141825442
- E-mail: Marwa.elsayed@pt.bsu.edu.eg
-
Contact:
- Marwa Elsayed Mohamed Lecturer, Ph.D
- E-mail: Marwa.elsayed@pt.bsu.edu.eg
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: ESWT + PFMT
Participants will receive low-intensity extracorporeal shockwave therapy and participants will perform a standardized pelvic floor muscle training program
|
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
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
|
|
Comparateur actif: PEMF + PFMT
Participants will receive pulsed electromagnetic stimulation combined with the same standardized pelvic floor muscle training program
|
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
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.
|
|
Autre: PFMT (Control)
Participants will receive a standardized pelvic floor muscle training program
|
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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Female Sexual Function Index (FSFI) Total Score
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Sexual Quality of Life Scale
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
14 mai 2026
Achèvement primaire (Estimé)
15 décembre 2026
Achèvement de l'étude (Estimé)
15 janvier 2027
Dates d'inscription aux études
Première soumission
7 mai 2026
Première soumission répondant aux critères de contrôle qualité
7 mai 2026
Première publication (Réel)
13 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
18 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
14 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- ESWT VS PEMF in FSD 2026
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .