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Female Sexual Dysfunction Assessment and Managment of Vaginismus

NCT06755099 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-01-01

No results posted yet for this 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 .

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.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2026-08-30
Completion
2026-11-30

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06755099 on ClinicalTrials.gov