Pelvic Organ Prolapse Prolapse of the vagina
Conditions
Interventions
nvt
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subject is female; 2. Subject is least 18 years of age; 3. Subject has at least a stage 2 apical prolapse and is planned to undergo vaginal surgical correction.
Exclusion criteria
Exclusion criteria: 1. Subjects who are pregnant or want to become pregnant; 2. Subjects who are not capable of giving informed consent; 3. Subject has a known sensitivity to polypropylene; 4. Subject has an indication for a concomitant procedure to treat SUI; 5. Subject is known with pelvic organ cancer (e.g. uterine, ovarian, bladder or cervical); 6. Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis; 7. Subject has a known neurologic or medical condition affecting bladder function (e.g. multiple sclerosis, spinal cord injury or stroke with residual neurologic deficit).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Surgical success (= anatomic cure, subjective improvement and no re-treatment necessary) in the treatment of apical prolapse compared to unilateral SSLF at 12 months; 2. Improvement of quality of life related to pelvic floor function at 12 months after surgery (PFDI-20). Secondary objectives | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Morbidity (Pain, ADL, hospital stay, surgical parameters, postoperative recovery, blood loss); 2. Quality of life score (PFDI-20): improvement stratified by compartment; 3. Sexual satisfaction (PISQ-12) improvement from baseline 4. To asses superiority of BSC mesh in surgical success (anatomic cure, subjective improvement and no re-treatment necessary) in the treatment of apical prolapse compared to unilateral SSLF at 12 months when non-inferiority has been proven; 5. Procedure related serious adverse events. | — |
Countries
Netherlands
Outcome results
None listed