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 @ 10:09 PM
Ignite Modification Date:
2025-12-24 @ 10:09 PM
NCT ID:
NCT04508335
Eligibility Criteria:
Inclusion Criteria:
* Females with Stage II pelvic organ prolapse or greater
* Users of a Gellhorn or ring style pessary, inclusive of sizes 1.5"-3", for \>3 months' duration
* Capable of giving informed consent
Exclusion Criteria:
* Pregnancy Short vaginal length (total vaginal length \< 8 cm), or subjective vaginal narrowing
* Deep vaginal erosion noted with removal of current pessary
* Presence of vesicovaginal fistula
* Presence of rectovaginal fistula
* Vaginal, rectal, or bladder tumor
* Presence of open wound or tear near vagina or anus by exam prior to removal of current pessary
* Untreated vaginal or urinary infection requiring treatment
* History of recurrent urinary tract or vaginal infections
* Inflammatory bowel disease
* Chronic pain syndromes of pelvic or anorectal origin
* Previous pelvic floor surgery in last 12 months
* Congenital malformation of bladder, rectum, or vagina
* Significant medical condition interfering with study participation (psychologic, neurologic, active drug/alcohol abuse, etc.)
* Planning pregnancy in next 6 months
* Previous treatment failure with a pessary
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04508335
Study Brief:
Protocol Section:
NCT04508335