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 @ 6:26 PM
Ignite Modification Date:
2025-12-24 @ 6:26 PM
NCT ID:
NCT01917968
Eligibility Criteria:
Inclusion Criteria:
1. Subject is female
2. Subject is ≥18 years of age
3. Subject has pelvic organ prolapse with the leading edge at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Ba≥0 or (for prolapse of the anterior compartment alone) C≥0 (for prolapse of the apical compartment alone) or C≥-1/2 TVL and Ba≥0 (for a multi-compartment prolapse that includes the anterior and apical compartments).
4. Subject reports of a bothersome bulge they can see or feel per PFDI-20, question 3 response of 2 or higher (i.e. responses of "somewhat", "moderately" or "quite a bit")
5. Subject or subject's legally authorized representative must be willing to provide written informed consent
6. Subject is willing and able to comply with the follow-up regimen
Exclusion Criteria:
1. Subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI) or tissue necrosis
2. Subject has history of pelvic organ cancer (e.g. uterine, ovarian, bladder, colo-rectal or cervical)
3. Subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area
4. Subject has taken systemic steroids (within the last month) or immunosuppressive or immunomodulatory treatment (within the last 3 months)
5. Subject has systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfans syndrome, Ehlers Danlos, collagenosis, polymyositis polymyalgia rheumatica)
6. Subject has a known neurologic or medical condition affecting bladder function (e.g. multiple sclerosis, spinal cord injury, or stroke with residual neurologic deficit)
7. Subject is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse (colpocleisis)
8. Subject has a previous prolapse repair with mesh in the target compartment
9. Subject is planning to undergo a concomitant repair with use of mesh in the non-target compartment
10. Subject is not able to conform to the modified dorsal lithotomy position
11. Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that includes the pelvis
12. Subject has uncontrolled diabetes mellitus (DM)
13. Subject is currently participating in or plans to participate in another device or drug study during this study
14. Subject has a known hypersensitivity to polypropylene mesh
15. Subject is pregnant or intends to become pregnant during the study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT01917968
Study Brief:
Protocol Section:
NCT01917968