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 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT00446693
Eligibility Criteria:
Inclusion Criteria:
* Female aged between 40-80 years (inclusive) who is not pregnant or planning to have further births.
* Subject suffers from Pelvic Organ Prolapse confirmed by vaginal inspection.
* Patient under reliable form of contraceptive measure or menopausal.
* Subject able to comprehend procedure and has signed Informed Consent Form for participation in this study.
* Subject able to complete the applicable questionnaires.
Exclusion Criteria:
* Planned to undergo hysterectomy.
* Uterine prolapse equal to or greater than 3rd degree.
* Documented Stress Urinary Incontinence on physical examination with full bladder or during complete urodynamic assessment with and without prolapse reduction.
* Any chronic active and uncontrolled disease.
* Vaginal bleeding disorders.
* Needing emergency surgery.
* Any acute disease.
* Blood clotting disorders and/or anticoagulant treatment.
* Known cognitive or psychiatric disorder.
* High operative risk.
* Any ongoing malignant disease.
* Concurrent participation in any other clinical trial
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT00446693
Study Brief:
Protocol Section:
NCT00446693