Pelvic Organ prolapse
Conditions
Interventions
Elevate Posterior or sacrospinous ligament fixation
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Women with a primary apical compartment prolapse stage * 2 requiring surgery. Patients with co-existing posterior defects or concomitant perineal surgery (perineoplasty) can be included.
Exclusion criteria
Exclusion criteria: - Previous prolapse surgery - Women of reproductive age desiring future pregnancy and childbirth - Unwilling to return for follow-up or language barriers - Co-morbidity that is associated with increased surgical risks, for instance women with ASA 3 or 4 classification. Up to the physician to decide. - Poor cognitive function, as subjectively assessed by the physician. - History of or current major psychiatric illness as subjectively assessed by the physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life related to pelvic floor function after 12 months measured using validated disease-specific quality of life questionnaires (UDI, DDI, IIQ) | — |
Secondary
| Measure | Time frame |
|---|---|
| Sexual function at one year after intervention measured using the PISQ-12 questionnaire, POP-Q, morbidity (including post-operative pain, complications and recovery of normal daily activities), generic quality of life, repeated pelvic floor surgery within 12 months after intervention and cost analysis. | — |
Countries
Netherlands
Outcome results
None listed