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 @ 2:32 PM
Ignite Modification Date:
2025-12-24 @ 2:32 PM
NCT ID:
NCT05812859
Eligibility Criteria:
Inclusion Criteria:
1. POP-Q stage 2 to 4 pelvic organ prolapse
2. Vaginal bulge symptoms as indicated by an affirmative response to either question 4 or 5 of the PFDI:
1. Do you usually have a sensation of bulging or protrusion from the vaginal area?
2. Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?
3. Undergoing reconstructive vaginal surgery for POP-Q stage 2 to 4 pelvic organ prolapse that must include anterior compartment repair and apical suspension.
4. Willing and able to use and self-manage novel vaginal orthosis after POP surgery from 2 weeks post-operative to 12 weeks post-operative.
5. Available for 2 and 6 weeks, 3, 6, and 12 months follow-up.
6. Able to complete study assessments, per clinician judgement.
7. Able and willing to provide written informed consent.
Exclusion Criteria:
1. Contraindication to surgical intervention as planned in the opinion of the treating surgeon (ie undergoing obliterative procedure).
2. History of previous vaginal reconstructive surgery with or without hysterectomy for POP.
3. Allergy to silicone used in Novel Vaginal Orthosis.
4. Allergy or contraindication to low-dose vaginal estrogen use.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05812859
Study Brief:
Protocol Section:
NCT05812859