Go to the Elevate Posterior website
Pelvic organ prolapse is a common health problem, with a life timerisk to undergo surgery of 11%.When dealing with an apical compartment prolapse the most frequent proposed procedure is sacrospinous ligamant fixation, but recently a mesh procedure (Elevate Posterior) was introduced. Although mesh is not recommended as primary procedure based on objectified adverse effects like exposure, pelvic pain and dyspareunia, thereis theoretical basis to believe that for apical prolapse, Elevate Posterior is beneficial compared to native tissue repair. We propose a multi-center RCT comparing sacropinous ligament fixation to Elevate Posterior in primary apical compartment prolapse.
To compare the effects of sacrospinous ligament fixation versus Elevate Posterior procedure on pelvic floor function.
A multi-center randomised controlled trial
Women with apical and anterior compartmentprolapse stage ≥ 2 requiring surgical treatment. Exclusion criteria: previous prolapsesurgery and enterocele stage ≥ 2 after hysterectomy.
Elevate Posterior PC or sacrospinous ligamentfixation.
Primary outcome: quality of life related to pelvic floor function atone year after intervention measured using UDI, DDI and IIQ questionnaires.
Secondaryoutcomes: sexual function measured using the PISQ-12, POP-Q, morbidity
(including post-operativepain, complications and recovery of normal daily activities), generic qualityof life, repeated pelvic floor surgery within 12 months after intervention andcost analysis.
The primary outcome in this study is quality of life related to pelvic floor function in patients subjected to Elevate Posterior PC or sacrospinous ligament fixation. A difference in reduction of the prolapse domain score (of the UDI) between both surgical techniques of 20% is considered to be a clinically relevant differencebetween the groups. With a power of 90% and and an alpha level of 0.05,the calculated sample size necessary is 38 in each group. With an estimated drop-out of 15%, a total of 45 women have to be randomized.
One of the secondary outcome variables in this study is sexual function in patients subjected to Elevate Posterior PC or sacrospinous ligament fixation. We aim to power this study to also sufficiently assess this secondary outcome. A difference of 10% from the maximum PISQ score (maximum score is 48, 10% being 4.8) was considered to be clinical relevant. Previous studies from Altman et al. have shown mean PISQ-scores 12 months after surgery of 35.1 with a 95% CI of 33.7 to 36.4 for the vaginal native tissue repair group. Based on this expected value in the native tissue group and to detect a difference in means of 4,8, with a power of 90% and an alpha level of 0.05 42 patients in each group are needed. Anticipating on a 15% drop-out rate, we intend to include 100 patients (50 patients in each arm).50 women in each treatment arm will be sufficient to assess a statistically significant difference in the primary outcome as well as the secondary outcome.
The economic evaluation of Elevate Posterior procedure versus sacrospinous ligament fixation will be performed from a societal perspective as both, a cost-effectivenessanalysis and cost-utility analysis. To perform cost-analysis volume data will be gatheredwith clinical report forms, available hospital information systems, and the Health and Labour Questionnaire.For patient outcome analysis the validated EUROQOL-5D (EQ-5D) questionnaireis used to generate health status scoring profiles over time.Cost-effectiveness analysis will take 3 months after completion of the data. The evaluation will include the direct medical costs, out-of-pocket expenses, andthe indirect non-medicalcosts of production losses. The direct medical costs will include the costs of all diagnostic and therapeutic interventions, hospital admissions, specialist consultations and out-of-hospitalcare. Out-of-pocket expenses encompass the costs of over-the-counter medication,travel expenses, extra washing, etc. Production losses will be estimated based onquestionnaire data concerning absence from work.
Anticipated start of this study is April 2012. The estimated duration of the recruitment phase of the study is 4 years . Follow-up till 36 months after surgery. Expected end ofstudy is April 2019.
Prof. Dr. J.P.W.R. Roovers, gynaecologist, AMC Amsterdam
Drs. C.M. Diedrich, research physician
Tel: +31 20 5661470,