Genetic predisposition of patients with vestibulodynia (chronic pain around the opening of the vagina): a case-control study

Not Applicable

• Conditions: ocalized provoked vulvodynia at the vestibule, known as vestibulodynia (VBD); Urological and Genital Diseases

• Registration Number: ISRCTN80500385
• Lead Sponsor: Associazione Italiana Vulvodinia Onlus

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-07-29
• Last Update Posted: 7 August 2023
• Study Completion: 2023-09-15

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

1. Women aged at least 18 years old and before menopause (absence of menstruation for 12 months)
2. Experience moderate to severe pain (minimum of 5/10 on a numerical rating scale in at least 90 % of attempted sexual intercourse) for the VBD group
3. Pain limited to the vestibule during vaginal intercourse and during activities exerting pressure on the vestibule (tampon insertion, tight jeans or pants, cycling, horseback riding) for VBD group
3. Presence of VBD for at least 3 months and diagnosed according to the standardized gynecological examination protocol by one of our staff gynecologists
4. Have a stable sexual partner (sexual activity should include some attempted vaginal penetrations to evaluate pain intensity)
5. Subject is willing to attempt sexual activity between visits
6. Read and signed informed consent

Exclusion Criteria

1. Active vulvovaginal infections at the time of their gynecological examination
2. Genital bleeding of unknown origin
3. Unwillingness to provide informed consent to the trial
4. Women with concomitant vulvar dermatosis or other vulvar disorders
5. Symptoms or signs in the past related to VBD, only for the Control group

Study & Design

• Study Type: Observational
• Study Design: Not specified