Female Sexual Dysfunction Assessment and Managment of Vaginismus

PHASE2/PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

January 1, 2025

Primary Completion Date

August 30, 2026

Study Completion Date

November 30, 2026

Conditions
Female Sexual Dysfunction
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."

Trial Locations (1)

Unknown

women's health hospital of Assiut University, Asyut

All Listed Sponsors
lead

Assiut University

OTHER

NCT06755099 - Female Sexual Dysfunction Assessment and Managment of Vaginismus | Biotech Hunter | Biotech Hunter