Evaluation of guidelines on the use of vaginal mesh implants for pelvic organ prolapse using the AGREE II instrument.

OBJECTIVE: To systematically evaluate the content and quality of national and international guidelines on vaginal mesh procedures for pelvic organ prolapse (POP). METHODS: We searched PubMed, Medline, Web of Science, and ScienceDirect from inception to March 2020 and organizations' websites. The quality of the guidelines was assessed independently by six appraisers using the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument. RESULTS: Five guidelines were included. Most guidelines recommended individualized treatments, clinical observation, and conservative treatment for asymptomatic women discouraging the use of mesh. Vaginal pessary and pelvic floor muscle training are unanimously considered effective treatments. Only two guidelines recommended weight loss. Each guideline recommended patient counseling supported by data on success rates and complications. Most guidelines highlighted the importance of a specialist experienced surgeon, multidisciplinary teams, and national/international registries. All guidelines highlighted potential benefits of the use of mesh and reported possible complications. The overall quality rating ranged between 4.2 and 6.3, suggestive of moderate to high quality. The highest mean score (92.5%) pertained to "Scope and Purpose" and "Clarity of Presentation", and the lowest to "Editorial Independence" (18%). Three out of five guidelines were "strongly recommended" by the appraisers. CONCLUSION: Although most guidelines were of moderate to high quality, methodological applicability, stakeholder involvement, and editorial independence were domains with low scores.

A systematic review on reporting outcomes and outcome measures in trials on synthetic mesh procedures for pelvic organ prolapse: Urgent action is needed to improve quality of research.

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.