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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT05969067
Eligibility Criteria:
Inclusion Criteria:
1. Females at least 18 years of age at the time of consent.
2. Able to understand and read English
3. Able and willing to provide written informed consent
4. Able to comply with the follow-up study protocol, per clinician judgment
5. Symptomatic POP (bulge or pressure) evidenced with vaginal prolapse with POP-Q measurement consistent with Stage II-IV.
6. RA SCP as desired surgical approach to correct apical prolapse
Exclusion Criteria:
1. Females who are pregnant, or intend to become pregnant during the study
2. Texas Department of Criminal Justice prisoners
3. A known history of sensitivity to propylene mesh
4. Prior prolapse repair surgery using mesh (abdominal, vaginal or rectal)
5. Active or chronic systemic infection including any pelvic infection, abscess
6. Has had history of primary pelvic organ cancer (uterine, ovarian, endometrial, cervical, bladder) or any cancer that is metastatic to the pelvis
7. Prior or current pelvic radiation, or chemotherapy.
8. Not a candidate for general anesthesia
9. History of systemic connective tissue or musculoskeletal disorders (scleroderma, SLE, Marfan's syndrome, Ehlers Danlos, polymyositis, Lambert Eaton syndrome etc)
10. History of neurologic condition affecting bladder function (multiple sclerosis, spinal cord injury, stroke with neurologic deficit)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05969067
Study Brief:
Protocol Section:
NCT05969067