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 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT00460434
Eligibility Criteria:
Inclusion Criteria:
Vaginal bulge symptoms as indicated by an affirmative response to either questions 4 or 5 of the PFDI:
* Do you usually have a sensation of bulging or protrusion from the vaginal area?
* Do you usually have a bulge or something falling out that you can see or feel in the vaginal area? Anterior vaginal prolapse defined by pelvic organ prolapse quantification (POP-Q) Point Aa ≥ -1 cm (i.e., -1,0,1,2, or 3 cm).
Surgical plan that includes a vaginal approach for apical or anterior prolapse repair.
Able and willing to complete data collection per protocol, including written informed consent.
Exclusion Criteria:
Pregnancy or planning pregnancy in the first postoperative year. Any prior mid urethral sling. Currently participating in another interventional study for urinary incontinence.
Untreated urinary tract infection (may be included after resolution).
Overt symptoms of stress urinary incontinence as defined by a positive response to any of the following 3 PFDI items:
* Do you usually experience urine leakage related to coughing, sneezing, or laughing?
* Do you usually experience urine leakage related to physical exercise such as walking, running, aerobics, or tennis?
* Do you usually experience urine leakage related to lifting or bending over? Currently being treated for stress urinary incontinence with pessary/incontinence ring, pelvic floor muscle exercise or medication (duloxetine and imipramine, and alpha agonists).
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00460434
Study Brief:
Protocol Section:
NCT00460434