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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07401134
Eligibility Criteria:
Inclusion Criteria:
* Women ≥ 18 years of age
* Undergoing perineorrhaphy and/or posterior colporrhaphy (rectocele repair/posterior repair) as part of their planned vaginal pelvic reconstructive surgery
* Physically able to apply medicated witch-hazel pads (MAJOR® Medi-Pads) and administer topical benzocaine spray (Dermoplast®) to the perineal area
* Able to understand and willing to provide informed consent
Exclusion Criteria:
* Known allergy or hypersensitivity to any of the study products or components, including witch hazel, benzocaine, aloe, or other product ingredients
* Minors
* Presence of an indwelling catheter expected to remain in place for ≥7 days postoperatively
* History of chronic pelvic pain syndromes that may confound postoperative pain assessment, including interstitial cystitis/bladder pain syndrome (IC/BPS), endometriosis, pudendal neuralgia, or vulvodynia
* Chronic use (\> 3 weeks of continuous use) of opioid pain medication
* Presence of vulvar dermatoses such as lichen sclerosus, lichen planus, or lichen simplex chronicus
* Currently pregnant or breastfeeding
* Anticipated inability to complete postoperative follow-up, including physical or cognitive limitations that would impede self-care or completion of study diaries
* Inability or unwillingness to provide informed consent or comply with study procedures
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT07401134
Study Brief:
Protocol Section:
NCT07401134