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Clinical Trials in Egypt / NCT06755099
Starting soon Phase 2/3

Female Sexual Dysfunction Assessment and Managment of Vaginismus

NCT06755099 · tracked via the Priya Life Science Egypt tracker
Sponsor
Assiut University
Phase
Phase 2/3
Started
2025-01-01
Last updated
2025-01-01

Condition(s) studied

Female Sexual Dysfunction

Investigational drug(s) / intervention(s)

Botox →Radiofrequency

Botox: The patient will be placed in gynecological position. Subsequently, the patient will be anesthetized with propofol bolus, a total of 270 mg IV sterilization of valval area with antiseptic solution then digital examination to assess the spasm of intriotus and vaginal walls under lowest possible doses then increasing the doses to allow for intra vaginal injection of Botox under full sedation. Pacik technique will be adopted for Botox Injection in the vagina . . One vial of frozen Botox 100 U will be diluted with 2 mL saline, without foaming or shaking the vial, giving a concentration of 2.5 U/0.05 mL . Using a small sized speculum and after bending the needle to 30° to facilitate injection into sub mucosal area,1 mL (50 U) of Botox will be injected into the right bulbocavernosus then into the left side .

Radiofrequency: Patients will be placed in prone position. After proper disinfection, the ischial spine (IS) and insertion point of the sacrospinous ligament will be identified using fluoroscopy medial to IS. 5 ml Lidocaine 2 % will be used to apply local anesthesia to the skin at the expected entry point for the radiofrequency cannula. Then a 20 G, 10 cm long and 1 cm active tip radiofrequency cannula will be introduced gradually utilizing 2 Hz motor stimulation until pudendal nerve is identified visually by the occurrence of contraction of the external anal sphincter muscle. Subsequently, pulsed radiofrequency lesioning at temperature limit of 42 C will be applied bilaterally to the pudendal nerves for 240 s (2 cycles of 120 s) after applying local anesthesia using 2 cm 2% lidocaine in its vicinity.

Study summary

The study aims at :

1. The extent female sexual dysfunction problem in community through questionnaire .
2. Compare effectiveness of two treatment options for vaginismus .

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
40 Years
Healthy volunteers
No
Inclusion Criteria: * • Age from 18to 40 years. * Women diagnosed with primary vaginismus. Vaginismus has been classified by Lamont (12) according to its severity into four degrees or grades: 1. In first degree (also known as grade 1 vaginismus), the patient has spasm of the pelvic floor that can be relieved with reassurance. 2. In the second degree, the spasm is present throughout the pelvis even with reassurance. 3. In third degree, the patient elevates her buttocks to avoid being examined. 4. In fourth degree vaginismus, the most severe form of vaginismus, the patient elevates the buttocks, retreats, and tightly closes her thighs to avoid examination Exclusion Criteria: * Refusing to participate in the study * Women whose husbands have an erectile dysfunction. * women with secondary vaginismus. * Women with psychiatric disorders. * Lacking the appropriate cooperation for treatment and follow-up procedure. * Having any contraindications to receiving botulinum, including allergies to albumin, botulinum toxin, or its injection components. * Previous history of treatment with botulinum or physiotherapy. * Infection at the injection site. * Diseases involving nerves and muscles, such as myasthenia gravis and Lambert-Eaton syndrome, vulvodynia, cutaneous problems at the vulva or perineum, anal fissure, urinary duct or rectum disorders, and coagulation disorders urging them to use anticoagulation drugs

Primary outcome measure(s)

  • - prevalence of female sexual dysfunction and vaginal penetration pain disorders - prevalence of female sexual dysfunction and vaginal penetration pain disorders. — 1 year
  • Reevaluate female sexual function index score after intervention — 6 months after intervention

Trial sites (1)

FacilityCityRegionStatus
women's health hospital of Assiut University Asyut Egypt

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06755099 on ClinicalTrials.gov ↗ ← All trials in Egypt