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Search / Trial NCT06755099

Female Sexual Dysfunction Assessment and Managment of Vaginismus

Launched by ASSIUT UNIVERSITY · Dec 24, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is focused on understanding female sexual dysfunction, particularly a condition called vaginismus, which makes it painful or difficult for women to engage in sexual activity. The study aims to find out how common this problem is in the community and to compare two different treatment options for women diagnosed with primary vaginismus.

To participate in this trial, women need to be between 18 and 40 years old and have been diagnosed with primary vaginismus. Participants will answer questionnaires and receive treatment, which may involve injections. It's important to note that women who have certain conditions, such as psychiatric disorders or previous treatments for vaginismus, will not be eligible for the study. If you or someone you know is interested, this trial is still in the planning stages and has not yet started recruiting participants.

Gender

FEMALE

Eligibility criteria

  • 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

About Assiut University

Assiut University, a prominent academic institution located in Egypt, is dedicated to advancing medical research and clinical trials that enhance healthcare outcomes. With a strong emphasis on innovation and collaboration, the university engages in a wide array of clinical studies across various disciplines, aiming to contribute valuable insights into disease prevention, diagnosis, and treatment. Assiut University's commitment to ethical research practices and rigorous scientific methodology ensures the integrity and reliability of its clinical trials, ultimately benefiting both the local community and the global medical landscape.

Locations

Assiut, , Egypt

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported