Prolapse
Conditions
Interventions
Pessary therapy or POP surgery
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Women with a prolapse stage 2 or more. 2. Women with moderate to severe POP symptoms. Moderate to severe POP symptoms is defined as a prolapse domain score > 33 on the validated Dutch version of the Pelvic Floor Distress Inventory (PFDI-20). 3. Women who have had a successful pessary fitting procedure: for the RCT. 4. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Prior urogynaecological (prolapse or incontinence) surgery 2. Probability of future childbearing 3. Insufficient knowledge of the Dutch language 4. Co-morbidity causing increased surgical risks 5. Major psychiatric illness 6. Prior pessary use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome: Global impression of improvement of POP symptoms at 24 months measured with PGI-I | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes: * Changes in symptom bother and disease-specific quality of life at 12 and 24 months follow-up * Changes of sexual function at 12 and 24 months follow-up * Changes in general quality of life at 3, 6, 12 and 24 months. * Adverse events/complications related to both treatment strategies during the study period * Development of prediction model to identify factors for failing of pessary and surgery. * Costs-effectiveness analyses | — |
Countries
Netherlands
Outcome results
None listed