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 @ 4:57 AM
Ignite Modification Date:
2025-12-25 @ 4:57 AM
NCT ID:
NCT07084818
Eligibility Criteria:
Inclusion Criteria:
* Women currently using office-based pessary management of at least stage 2 POP will be recruited:
* English-speaking natal females 18 years or older
* Stage II-IV POP desiring continued pessary management.
* Primary indication for pessary management is treatment of POP
Exclusion Criteria:
* Primary indication for pessary is for management of stress urinary incontinence
* Vesicovaginal fistula or rectovaginal fistula
* Vaginal, rectal or bladder malignancy
* Genitourinary infection requiring treatment\*
* Ongoing treatment for vaginal infections (e.g., chronic bacterial vaginosis)\*
* Inflammatory bowel disease (Crohn's or ulcerative colitis)
* Pelvic or anorectal chronic pain
* Pelvic floor surgery within the past 6 months or planning to undergo pelvic floor surgery
* Congenital malformation of the bladder, rectum or vagina
* The following special populations will be excluded:
Adults unable to consent Individuals who are not yet adults (infants, children, teenagers) Pregnant women (or planning pregnancy in the next 6 months) (women of childbearing age will be verbally queried and offered pregnancy testing if uncertain) Prisoners
\*Patients with acute vaginal infections will be eligible for enrollment 2 weeks after completing treatment and have resolution of symptoms
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT07084818
Study Brief:
Protocol Section:
NCT07084818