Pelvic organ prolapse, vault prolapse, laparoscopic sacrocolpopexy, sacrospinous fixation
Conditions
Interventions
1. Laparoscopic sacrocolpopexy
2. Vaginal sacrospinous fixation.
Sponsors
Máxima Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Symptomatic vault prolapse POP-Q grade 2 which needs surgical treatment; 2. Eligible for both surgical treatments.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. Previous surgical treatment of vault prolapse; 2. Contra-indication for a surgical intervention; 3. Incapacitated patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is disease specific quality of life during a follow-up period of one year using the Dutch validated version of the Urinary Distress Inventory (UDI). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome will be the effect of the surgical treatment on prolapse related symptoms, post-operative recovery, procedure related morbidity, sexual function, quality of life, anatomical results using the POP-Q classification until one year follow-up, type and number of re-interventions, costs and cost-effectiveness and long term complications. | — |
Contacts
Public ContactA.L.W.M. Coolen
Polikliniek gynaecologie, tav A.Coolen Postbus 7777
Outcome results
None listed