ICS 2022: A Randomised Controlled Trial Of The Clinical And Cost‐Effectiveness Of Vaginal Pessary Self‐Management Vs Clinic-Based Care For Pelvic Organ Prolapse

(UroToday.com) A parallel two-arm, superiority, multicentre randomized controlled trial study aim was to determine the effectiveness and cost-effectiveness of self-management of a vaginal pessary on prolapse-specific quality of life (at 18 months) for women with pelvic organ prolapse (POP) when compared to pessary clinic-based care. Inclusion criteria were women age ≥18 years, pessary use of any type/material (excluded: Shelf, Gellhorn, or Cube pessaries), and retention of a pessary for at least two weeks.

Exclusion were those with limited manual dexterity, were judged to have a cognitive deficit that prevented informed consent or self-management, were pregnant, or would have required self-management teaching in a language other than English.

Quality of life was measured using the Pelvic Floor Impact Questionnaire-7 (PFIQ−7). A cost-effectiveness analysis, in terms of quality adjusted life years (QALYs), was conducted to compare the costs and benefits of self-management versus clinic-based care over 18 months. Resource use data were collected using a study-specific Health Resource Use Questionnaire. Secondary outcomes included self-reported complications, general self-efficacy, pessary-specific self-efficacy, and adverse events. Baseline questionnaire and outcome data were collected via follow-up questionnaires at 6, 12, and 18 months post-randomization.

The recruitment was 340 women with POP who used a pessary, 169 performed self-management, and 171 clinic-based care. Group allocation was by remote web-based application, with minimization by age, pessary user type (new or existing), and recruiting center. Participants, researchers, or those delivering the intervention were blinded to group allocation. Women in the self-management group received a 30-minute self-management teaching appointment, an information leaflet, a two-week follow-up call, and a support telephone number for their local center. Women in the clinic-based care group were seen in a visit per the center’s usual pessary practice.

The sensitivity analyses and subgroup analyses of the PFIQ-7 data all showed no significant difference between groups. Analysis adjusting for clinic-based care appointments canceled due to COVID-19 also did not alter the findings. At 18 months, there was a lower mean proportion of pessary complications in the self-management group (16.7% vs 22.0%, adjusted mean difference ‒3.8%, 95% CI –6.9% to ‒0.8%). Although there was no statistically significant difference between groups in general self-efficacy at 18 months, women who self-managed their pessary were more confident as statistically significant differences were found for all three activities analyzed (managing pessary problems, removing their pessary, and inserting their pessary). 30 serious adverse events (17 self-management, 13 clinic-based care) were reported.

There was no significant difference in the mean number of QALYs gained between the 2 groups, but the mean cost was lower for self-management compared to clinic-based care (£578 vs £728).
Clinic-based costs were predominantly related to clinic support and NHS primary and secondary resource use. The incremental net benefit at a willingness to pay of £20,000 per QALY gained was estimated at £564, with an 80.8% probability of cost-effectiveness when compared to clinic-based care. Further analysis suggested the intervention is likely to remain cost-effective for a minimum of 5 years after the completion of the trial.

The authors concluded that pessary self-management is cost-effective, and the absence of any related adverse events indicated that pessary self-management is safe. Also, self-management as an option for women who use a vaginal pessary will cost health services less to deliver than standard clinic-based care models, an important message for providers of pessary care.

Presented by: Suzanne Hagen, Glasgow Caledonian University, United Kingdom

Written by: Diane Newman, DNP, CRNP, FAAN, BCB-PMD, Urologic Nurse Practitioner, Adjunct Professor of Urology in Surgery, Senior Research Investigator, Perelman School of Medicine, University of Pennsylvania during the International Continence Society Annual Meeting, September 7-10, 2022, Vienna, Austria.