Authors' objectives: This health technology assessment evaluates the effectiveness, safety, and cost-effectiveness of vaginal pessaries for people with pelvic organ prolapse or stress urinary incontinence. It also evaluates the budget impact of publicly funding vaginal pessaries and the experiences, preferences, and values of people with pelvic organ prolapse or stress urinary incontinence.

Authors' results and conclusions: Results We included 15 studies in the clinical evidence review. Compared with no treatment for people with SUI, pessaries were associated with a significant improvement in some symptoms at 14 days follow-up (SUI subscore of Urinary Symptom Profile, mean difference −2.20; 95% CI −3.47 to −0.93; GRADE: Very low). Compared with pelvic floor muscle training (PFMT), pessaries were associated with no difference in improvement at 12 months follow-up for some symptoms (Urinary Distress Inventory subscale of the Pelvic Floor Distress Inventory, risk ratio = 0.86; 95% CI 0.64 to 1.16; GRADE: Low). For people with POP, pessaries were associated with a significant improvement in the Pelvic Organ Prolapse Distress Inventory score and in sexual function compared with PFMT plus feedback/electrical stimulation/lifestyle advice at 12- and 24-month follow ups (GRADE: Low). Pessary continuation rate at 12 months follow up was reported to be 60% (44/74 patients) (GRADE: Very low). When evaluating various POP and SUI treatments in sequential order, pessaries were within the most cost-effective treatment sequence; therefore, it is likely to be a cost-effective intervention for treating POP and SUI. There was a high degree of certainty that pessaries were cost-effective in a population with POP, and a moderate degree of certainty in a population with SUI. When the treatment sequence of pessaries and surgery was compared with surgery alone, the pessaries treatment sequence dominates surgery in the cohort with POP, and in the cohort with SUI pessaries had an incremental cost-effectiveness ratio (ICER) of $1,033 per QALY gained. The annual budget impact of publicly funding vaginal pessaries in Ontario over the next 5 years ranges from $0.3 million in year 1 to $0.5 million in year 5 for POP, and $0.2 million in year 1 to $0.3 million in year 5 for SUI. We included one study in our quantitative evidence review and spoke to 29 people in our direct patient engagement. The evidence indicated that patient preferences vary and that patients accept the risks of their chosen treatment option. The 24 people we spoke with who had direct experience with vaginal pessaries reported that their POP and/or SUI limited their social activities and restricted their activity levels, taking a huge emotional toll. Many were hesitant or even fearful of surgery due to side effects and perceived failure rate of the surgery. Most people reported that pessaries relieved most or all of their symptoms, allowing them to return to their normal daily activities. However, wait times for pessary fittings could be as long as 2 years, and out-of-pocket expenses could be a barrier for people without extended insurance. Conclusions For people with SUI, vaginal pessaries may improve symptoms compared with no treatment, but the evidence is very uncertain. Pessaries may result in little to no difference in longer-term improvement of SUI symptoms compared with PFMT. For people with POP, pessaries may improve some longer-term symptoms, as well as sexual function compared with PFMT. For people with symptomatic POP and SUI, vaginal pessaries may be a cost-effective intervention to be used within a stepped care model (a sequence of interventions followed after the current treatment proves ineffective). We estimate that publicly funding vaginal pessaries in Ontario would result in a total 5-year budget impact of $2.0 million for POP and $1.3 million for SUI. People with POP and/or SUI reported pessary use as being an effective treatment option to manage their symptoms.

Authors' recommendations: Ontario Health, based on guidance from the Ontario Health Technology Advisory Committee, recommends publicly funding vaginal pessaries for people with pelvic organ prolapse or stress urinary incontinence

Authors' methods: We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using ROBIS, the Cochrane Risk of Bias tool, and the Newcastle–Ottawa Scale and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and conducted a cost–utility analysis with a 10-year horizon from a public payer perspective. We also analyzed the budget impact of publicly funding vaginal pessaries for individuals with pelvic organ prolapse and/or stress urinary incontinence in Ontario. We explored the underlying values, needs, and priorities of those who have lived experience with POP and/or SUI, as well as the preferences and perceptions of both patients and providers of vaginal pessaries.

Project Status: Completed

URL for project: https://www.hqontario.ca/evidence-to-improve-care/health-technology-assessment/reviews-and-recommendations/vaginal-pessaries-for-pelvic-organ-prolapse-or-stress-urinary-incontinence

Year Published: 2021

URL for published report: https://www.hqontario.ca/Portals/0/Documents/evidence/reports/hta-vaginal-pessaries-for-pelvic-organ-prolapse-or-stress-urinary-incontinence-en.pdf

Requestor: Ontario Health Technology Advisory Committee (OHTAC); Ontario Ministry of Health

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Canada

Province: Ontario

Pubmed ID: 34055111

Organisation Name: Ontario Health

Contact Address: 130 Bloor Street West, 10th Floor

Contact Name: Nancy Sikich

Contact Email: OH-HQO_hta-reg@ontariohealth.ca

Copyright: © Queen’s Printer for Ontario, 2021 The copyright for all Ontario Health publications is owned by the Queen’s Printer for Ontario. Materials may be reproduced for commercial purposes only under a licence from the Queen’s Printer. For further information or to request a licence to reproduce content, please contact: Senior Copyright Advisor Publications Ontario 416-326-5153 copyright@ontario.ca