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 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT01648751
Eligibility Criteria:
Inclusion Criteria:
* Women in good health aged 40-80
* Has symptoms of pelvic organ prolapse; answers yes to at least 1 of the following questions:
Do you feel or see a vaginal bulge? Do you feel pressure in the vagina?
* Meets POP-Q criteria on exam for stage I, II, or III prolapse
* Interested in PFPT for management of POP
* Normal mammogram within 1 year of enrollment
Exclusion Criteria:
* Prior surgery for prolapse or incontinence
* Other prior interventions for prolapse (e.g. pessary, PFPT)
* Previous bilateral salpingo-oophorectomy (women with 1 ovary will be eligible)
* Known liver dysfunction
* Connective tissue diseases known to affect collagen or elastin remodeling (including: Lupus, Rheumatoid Arthritis, Scleroderma, Sjogrens syndrome, Marfan syndrome, and Ehlers-Danlos syndrome)
* Unevaluated abnormal vaginal bleeding or abnormal pap smear in the previous year
* BMI \> 35 kg/m2
* Estrogen therapy (including birth control) in the previous year
* Current or prior breast or pelvic malignancy (ovarian, tubal, uterine, cervical or vaginal)
* Contraindication to hormone use (i.e. thromboembolic disorder, use of anti-coagulants, coronary artery disease, history of stroke)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT01648751
Study Brief:
Protocol Section:
NCT01648751