Tretment of patients with vestibulodynia, the most common manifestation of the vulvodynia Urological and Genital Diseases
Conditions
Interventions
One or more members of the staff who do not work directly with the subject will be responsible for assignment to active or placebo treatment based on random assignment. The patients will be trained to
Sponsors
Ospedale dei Bambini Vittore Buzzi
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women are at least 18 years of age and premenopausal, defined as having menstruated within the past 12 months 2. Women experience moderate to severe pain, defined as a minimum score of 4 out of 10 on a numeric rating scale, in at least one of three parameters (pain, dyspareunia, or swab test) during at least 90% of sexual intercourse attempts 3. Pain is localized to the vestibule during vaginal intercourse and during activities that exert pressure on the vestibule, such as tampon insertion, wearing tight jeans or pants, cycling, or horseback riding 4. Women have had a diagnosis of vestibulodynia (VBD) for at least 6 months, confirmed using a standardized gynecological examination protocol
Exclusion criteria
Exclusion criteria: 1. Women have active vulvovaginal infections at the time of their gynecological examination 2. Women have genital bleeding of unknown origin 3. Women are concurrently enrolled in other interventional clinical trials 4. Women are unwilling to provide informed consent to participate in the trial 5. Women have used topical drugs in the past 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pain intensity is measured using a 0–10 point visual analog scale (VAS) at baseline, 60 days, and 120 days 2. Dyspareunia is measured using a 0–10 point visual analog scale (VAS) at baseline, 60 days, and 120 days 3. Vestibular pain sensitivity is measured using the cotton swab test at baseline, 60 days, and 120 days 4. Percentage change in pain scores is measured using a 0–10 point visual analog scale (VAS) at baseline, 60 days, and 120 days 5. Absolute change in pain scores is measured using a 0–10 point visual analog scale (VAS) at baseline, 60 days, and 120 days | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
Italy
Contacts
Public ContactFilippo Murina
Outcome results
None listed