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NOT YET RECRUITING
NCT06755099
PHASE2/PHASE3

Female Sexual Dysfunction Assessment and Managment of Vaginismus

Sponsor: Assiut University

View on ClinicalTrials.gov

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 .

Official title: Experience of Vaginismus in Outpatient Attendants in Assiut University Women's Health Hospital: Prevalence, Impact on Quality of Life and Management

Key Details

Gender

FEMALE

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-01-01

Completion Date

2026-11-30

Last Updated

2025-01-01

Healthy Volunteers

No

Interventions

DRUG

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 .

DEVICE

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.

Locations (1)

women's health hospital of Assiut University

Asyut, Egypt