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 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT01491334
Eligibility Criteria:
Inclusion Criteria:
* Subject is female of 21 years or older AND HAS AT LEAST ONE OF THE FOLLOWING
* No evidence of pelvic organ prolapse and no prior pelvic surgery
* Stage 1 or greater pelvic organ prolapse affecting one or more vaginal compartments and no prior pelvic surgery
* Stage 2 or greater pelvic organ prolapse affecting one or more vaginal compartments and reconstructive surgery is scheduled
Exclusion Criteria:
* Active skin infection or ulceration within the vagina
* Presence of a vaginal septum;
* Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder;
* Ongoing radiation therapy for pelvic cancer;
* Impacted stool
* Recent (less than three months) pelvic surgery;
* Significant pre-existing pelvic pain including levator ani syndrome, severe vaginismus or vulvodynia;
* Severe hemorrhoids
* Surgically absent rectum or bladder
* Significant circulatory or cardiac conditions that could cause excessive risk from the examination as determined by attending physician
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
21 Years
Study:
NCT01491334
Study Brief:
Protocol Section:
NCT01491334