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 @ 2:23 PM
Ignite Modification Date:
2025-12-24 @ 2:23 PM
NCT ID:
NCT06634459
Eligibility Criteria:
Inclusion Criteria:
* English-speaking natal females ≥ 18 years of age
* Willing to self-maintain (insert/remove) pessary
* Pessary naïve with Stage II-IV POP desiring conservative management with a pessary
* Primary indication for use of pessary is treatment of pelvic organ prolapse
Exclusion Criteria:
* Primary indication for pessary use is for management of stress urinary incontinence
* Prior mesh-augmented prolapse repair (i.e. transvaginal mesh, sacrocolpopexy)
* Short vaginal length (TVL \< 8cm) or subjective vaginal narrowing
* Vaginal fistula (e.g. rectovaginal, vesicovaginal or any type of fistula involving the vagina)
* Vaginal, rectal or bladder malignancy
* Genitourinary infection requiring treatment (See below 1)
* Ongoing treatment for vaginal infections (e.g., chronic bacterial vaginosis) (See below 2)
* 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
* Pregnant or planning pregnancy in the next 6 months
* Prior failure of pessary for POP
* History of hydroureter, hydronephrosis, or impaired renal function secondary to prolapse
1. Patients with acute vaginal infections will be eligible for enrollment 2 weeks after completing treatment with resolution of symptoms
2. OK to be on prophylactic/suppressive therapy for HSV
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06634459
Study Brief:
Protocol Section:
NCT06634459