Elevate Anterior Trial
Pelvicorgan prolapse is a common health problem, with a life time risk to undergo surgery of 11%. Many patients have a combination of different compartments involved in the prolapse of which the most prevalent combination is apical and anterior compartment prolapse. Sacrospinousligament fixation combined with anterior colporraphy is the most frequent proposed procedure, but recently a mesh procedure (Elevate Anterior PC) was introduced that covers both compartments in one procedure. Although mesh is not recommended as primary procedure based on objectified adverse effects like exposure, pelvic pain and dyspareunia,there is theoretical basis to believe that for the combination of apical and anteriorcompartment prolapse, Elevate Anterior PC is beneficial compared to native tissue repair.We propose a multi-center RCT comparing the combination of sacropinous ligament fixationand anterior colporraphy to Elevate Anterior PC in primary apical and anterior compartment prolapse.
Tocompare the effects of sacrospinous ligament fixation combined with anterior colporrhaphy versus Elevate Anterior procedure on pelvic floor function.
A multi-center randomised controlled trial
Inclusion criteria: sexually active women with apical and anterior compartmentprolapse stage ≥ 2 requiring surgical treatment. Exclusion criteria: previous prolapsesurgery and enterocele stage ≥ 2 after hysterectomy.
Elevate Anterior PC or sacrospinous ligament fixation combined with anterior colporrhaphy.
Primary outcome: quality of life related to pelvic floor function atone year after intervention measured using UDI, DDI and IIQ questionnaires.
Secondary outcomes: 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 pelvicfloor function inpatients subjected to Elevate Anterior PC or sacrospinous ligament fixation combined with anterior colporrhaphy surgery. A difference in reduction of the prolapsedomain score (of the UDI) between both surgical techniques of 20% is consideredto be a clinically relevant difference between the groups. With a powerof 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 Anterior PC or sacrospinous ligament fixation combined with anterior colporrhaphysurgery. 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 studiesfrom 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.
Anticipatingon 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 Anterior procedure versussacrospinous ligament fixationcombined with anterior colporrhaphy will be performed from a societal perspective as both, a cost-effectiveness analysis and cost-utility analysis.To perform cost-analysis volume data will be gathered with clinical report forms, available hospital informationsystems, and the Health and Labour Questionnaire. For patient outcome analysis the validated EUROQOL-5D(EQ-5D) questionnaire is 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 diagnosticand 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 on questionnaire data concerning absence from work.
Anticipated start of this study is February 2012. The estimatedduration of the recruitment phase of the study is 12 months. Follow-up till 12 months after surgery. Expected end of study is April 2014.
Dr. J.P.W.R. Roovers, gynaecologist, AMC Amsterdam
Drs.M.A. Weber, research physician,