Thais R de Mattos Lourenco1, Vasilis Pergialiotis2, James M N Duffy3,4, Constantin Durnea5, Abdullatif Elfituri5, Jorge M Haddad1, Cornelia Betschart6, Gabriele Falconi7, Stergios K Doumouchtsis2,5,8. 1. Department of Obstetrics and Gynaecology, Urogynaecology Division, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil. 2. Laboratory of Experimental Surgery and Surgical Research N S Christeas, University of Athens, Medical School, Athens, Greece. 3. Balliol College, University of Oxford, Oxford, United Kingdom. 4. Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom. 5. Department of Obstetrics Gynaecology, Epsom St Helier University Hospitals NHS Trust, London, United Kingdom. 6. Department of Gynecology, University Hospital of Zurich, Zurich, Switzerland. 7. Department of Obstetrics and Gynaecology, San Bortolo Hospital, Vicenza, Italy. 8. St George's University of London, London, UK.
Abstract
The use of synthetic mesh in pelvic organ prolapse surgery is being closely scrutinized because of serious concerns regarding life-changing complications such as erosion, pain, infection, bleeding, dyspareunia, organ perforation, and urinary problems. Randomized trials and their syntheses in meta-analysis offer a unique opportunity to assess efficacy and safety. However, outcomes and outcome measures need to be consistently selected, collected, and reported across randomized trials to be effectively combined in systematic reviews. AIMS: We evaluated outcome and outcome measure reporting across randomized controlled trials on surgical interventions using synthetic mesh for pelvic organ prolapse. METHODS: Systematic review of randomized controlled trials using synthetic mesh for the treatment of pelvic organ prolapse. The selected studies were evaluated using Jadad and MOMENT criteria. Outcomes and outcome measures were systematically identified and categorized. RESULTS: Seventy-one randomized trials were included. Twenty-four different types of mesh were identified. Included trials reported 110 different outcomes and 60 outcome measures. Erosion (40 trials, 78%), pain (29 trials, 56%), bleeding (31 trials, 61%), and dyspareunia (25 trials, 49%) were the most frequently reported outcomes. The longest follow up was 74 months. CONCLUSIONS: Most randomized trials evaluating surgical interventions using synthetic mesh for pelvic organ prolapse failed to report on clinically important outcomes and to evaluate efficacy and safety over the medium- and long-term. Developing and implementing a minimum data set, known as a core outcome set, in future vaginal prolapse trials could help address these issues.
The use of synthetic mesh in pelvic organ prolapse surgery is being closely scrutinized because of serious concerns regarding life-changing complications such as erosion, pain, infection, bleeding, dyspareunia, organ perforation, and urinary problems. Randomized trials and their syntheses in meta-analysis offer a unique opportunity to assess efficacy and safety. However, outcomes and outcome measures need to be consistently selected, collected, and reported across randomized trials to be effectively combined in systematic reviews. AIMS: We evaluated outcome and outcome measure reporting across randomized controlled trials on surgical interventions using synthetic mesh for pelvic organ prolapse. METHODS: Systematic review of randomized controlled trials using synthetic mesh for the treatment of pelvic organ prolapse. The selected studies were evaluated using Jadad and MOMENT criteria. Outcomes and outcome measures were systematically identified and categorized. RESULTS: Seventy-one randomized trials were included. Twenty-four different types of mesh were identified. Included trials reported 110 different outcomes and 60 outcome measures. Erosion (40 trials, 78%), pain (29 trials, 56%), bleeding (31 trials, 61%), and dyspareunia (25 trials, 49%) were the most frequently reported outcomes. The longest follow up was 74 months. CONCLUSIONS: Most randomized trials evaluating surgical interventions using synthetic mesh for pelvic organ prolapse failed to report on clinically important outcomes and to evaluate efficacy and safety over the medium- and long-term. Developing and implementing a minimum data set, known as a core outcome set, in future vaginal prolapse trials could help address these issues.
Authors: Thais Regina de Mattos Lourenço; Vasilis Pergialiotis; Constantin M Durnea; Abdullatif Elfituri; Jorge Milhem Haddad; Cornelia Betschart; Gabriele Falconi; Christiana Campani Nygaard; Stergios K Doumouchtsis Journal: Int Urogynecol J Date: 2021-04-08 Impact factor: 2.894