Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT02543593
Eligibility Criteria:
Inclusion Criteria:
1. Experience moderate to severe pain in at least 90% of attempted sexual intercourse;
2. Experience moderate to severe pain during cotton swab test, in one or more regions of the vestibule (minimum of 5/10 on a subjective numeric scale of pain intensity);
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);
4. Presence of PVD for at least 6 months and diagnosed according to the standardized gynecological examination protocol by one of our staff gynecologists;
5. Have a stable sexual partner with regular sexual activity including penetration.
Exclusion Criteria:
1. Other pelvic pathology associated with pelvic pain (e.g., deep dyspareunia);
2. Chronic pain conditions (e.g. fibromyalgia, low back pain, chronic migraines);
3. Use of medication that can influence the perception of pain (eg analgesic, opioids, antiepileptic, muscle relaxant);
4. Pregnancy for less than one year and breastfeeding;
5. Anterior vulvar or vaginal surgery;
6. Refusal to refrain from other treatments one month prior to first treatment study until the last 3-month follow-up assessment;
7. Important urogynecologic symptoms (urinary or anal incontinence, urinary urgency, pelvic organ prolapse, active urinary tract or vaginal infection or earlier in the last 3 months, etc.);
8. Contraindications to tDCS (e.g. metallic implant in or near the skull, history of epilepsy, pacemaker);
9. Previously received tDCS treatment.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
17 Years
Maximum Age:
45 Years
Study:
NCT02543593
Study Brief:
Protocol Section:
NCT02543593