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:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-24 @ 6:43 PM
NCT ID:
NCT02502357
Eligibility Criteria:
Inclusion Criteria:
* Women who undergo vaginal hysterectomy with minimally invasive sacrocolpopexy
* Age ≥18 years
* English speaking
* Available for 2 week follow up
* Able to complete study questionnaires
Exclusion Criteria:
* History of chronic pain prior to surgery
* Pain during intercourse or in lower abdomen or genital region at baseline prior to index surgery (identified if patient answers yes to question 20 on the Pelvic Floor Distress Inventory-20)
* Hearing impairment
* Pregnancy by self-report or positive pregnancy test
* Active pelvic infection, herpes, candidiasis
* Indication for surgery is due to neoplasm
* History of pain syndromes including fibromyalgia, interstitial cystitis, dysmenorrhea, and depression
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02502357
Study Brief:
Protocol Section:
NCT02502357