A randomised controlled trial of the clinical and cost‐effectiveness of vaginal pessary self‐management vs clinic-based care for pelvic organ prolapse

Hagen S1, Bugge C2, Elders A1, Best C2, Mason H1, Manoukian S1, Goodman K1, Melone L1, Dembinsky M2, Dwyer L3, Kearney R3

Research Type

Clinical

Abstract Category

Pelvic Organ Prolapse

Best Clinical Abstract
Abstract 430
Best Urogynaecology and Female & Functional Urology
Scientific Podium Session 27
Saturday 10th September 2022
09:50 - 10:05
Hall K1
Clinical Trial Conservative Treatment Pelvic Organ Prolapse Prolapse Symptoms Quality of Life (QoL)
1. Glasgow Caledonian University, 2. University of Stirling, 3. Manchester University Hospitals NHS Foundation Trust
In-Person
Presenter
S

Suzanne Hagen

Links

Abstract

Hypothesis / aims of study
To determine the effectiveness and cost-effectiveness of self-management of a vaginal pessary on prolapse-specific quality of life for women with pelvic organ prolapse when compared to clinic-based care.
Study design, materials and methods
This was a parallel two-arm, superiority, multicentre randomised controlled trial, which assessed the effectiveness of self-management compared to clinic-based care on prolapse-specific quality of life at 18 months for women who use a pessary for vaginal prolapse. The setting was NHS outpatient pessary clinics in the UK. The inclusion criteria were age ≥18 years, pessary use of any type/material (except Shelf, Gellhorn or Cube pessaries) and retention of a pessary for at least two weeks. Women were excluded if they had limited manual dexterity, were judged to have a cognitive deficit that prevented informed consent or self-management, were pregnant, or would have required the self-management teaching in a language other than English. 

The primary outcome was prolapse-specific quality of life at 18 months, measured using the Pelvic Floor Impact Questionnaire-7 (PFIQ−7) (1), which ranges from 0 to 300 with higher scores indicating worse adverse impact. Secondary outcomes included participant-reported complications (study-specific Pessary Complications Questionnaire), general self-efficacy (the General Self-Efficacy Questionnaire) (2), pessary-specific self-efficacy (study-specific Pessary Confidence Questionnaire), and adverse events. 

A sample size of 330 women (165 per group) was required to provide 90% power to detect a difference of 20 points in the PFIQ−7 score at 18 months after randomisation, assuming a standard deviation of 50, two-sided alpha of 0.05, and 20% loss to follow-up. Women were randomised to either self-management or clinic-based care on an even allocation basis. Group allocation was by remote web-based application, with minimisation by age, pessary user type (new or existing) and recruiting centre. No 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 centre. Women in the clinic-based care group returned to clinic as advised by the treating health care professional in line with that centre’s usual pessary practice. Women completed a baseline questionnaire and outcome data were collected via follow-up questionnaires at 6, 12 and 18 months post-randomisation. 

A single final analysis was undertaken, with the primary analysis conducted according to the intention-to-treat principle with all randomised participants included. The PFIQ-7 was summarised using descriptive statistics by group for each time-point and comparisons between randomised groups were made using repeated measures mixed models. The analysis adjusted for baseline PFIQ-7 scores and minimisation covariates (age and pessary user type as fixed effects and centre as a random effect). The analysis of secondary outcomes was similar to PFIQ-7, other than repeated measures were not included in the mixed model for general self-efficacy and only counts were reported for adverse events. Pessary complications were measured for each participant by calculating the number of complications reported as a proportion of all the applicable complications listed in the Pessary Complications Questionnaire.  

Sensitivity analyses of the primary outcome were carried out under a range of assumptions and analysis methods to investigate, for example, the effect of missing data and crossover. Subgroup analyses of the primary outcome were also conducted (subgroups were age <65 vs >=65, new vs existing pessary user and hysterectomy at baseline vs no hysterectomy at baseline).

A within-trial economic evaluation was conducted to compare the costs and benefits of self-management with clinic-based care over the 18 months after randomisation, measured in terms of quality adjusted life years (QALYs) which was the primary outcome for the cost-effectiveness analysis. Resource use data were collected using a study-specific Health Resource Use Questionnaire.
Results
Participants were recruited between May 2018 and February 2020 at 21 centres across the UK where pessary care was delivered. The recruitment target was met, with 340 women with prolapse and receiving pessary care being randomised; 169 to self-management and 171 to clinic-based care. The PFIQ-7 scores at each time point are summarised in Table 1 along with the results of the primary analysis. 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 cancelled due to COVID-19 also did not alter the findings.

At 18 months, there was a lower mean proportion of pessary complications (Table 2) in the self-management group (16.7% vs 22.0%, adjusted mean difference ‒3.8%, 95% CI –6.9% to ‒0.8%). There was no statistically significant difference between groups in general self-efficacy at 18 months, however self-managing women were more confident in pessary self-management and statistically significant differences were found for all three activities analysed (managing pessary problems, removing their pessary, and inserting their pessary).

There were no reported unexpected serious adverse reactions. There were 30 serious adverse events (17 self-management, 13 clinic-based care), all of which were unrelated to the intervention received. 

There was no significant difference in the mean number of QALYs gained between self-management and clinic-based care, but the mean cost was lower for self-management compared to clinic-based care (£578 vs £728). These costs refer predominantly 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. Decision analytic modelling suggested the intervention is likely to remain cost-effective for a minimum of 5 years after the completion of the trial.
Interpretation of results
There is no evidence that pessary self-management improves prolapse-specific quality of life, based on no difference being found between groups in the primary outcome measured by PFIQ-7 at 18 months. This primary finding is corroborated by sensitivity and subgroup analyses. However, there is evidence that self-management is effective in reducing complications and improving self-efficacy specific to pessary management activities. There is evidence that pessary self-management is cost-effective, and the absence of any related adverse events indicates that pessary self-management is safe.
Concluding message
Self-management as an option for women who use a vaginal pessary to manage pelvic organ prolapse is an acceptable intervention that will not make women’s quality of life better or worse than clinic-based care. Self-management will however reduce the pessary-related complications that women experience and will cost health services less to deliver than standard clinic-based care models.
Figure 1
Figure 2
References
  1. Barber M, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). American journal of obstetrics and gynecology. 2005 Jul 1;193(1):103-13.
  2. Schwarzer R, Jerusalem M. Generalized self-efficacy scale. In: Weinman J, Wright S, Johnston M, editors. Measures in health psychology: a user’s portfolio. Causal and control beliefs. Windsor: NFER-NELSON; 1995. p. 35–7.
Disclosures
Funding This project is funded by the National Institute for Health Research (NIHR) Health Technology Assessment Programme (16/82/01). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. Clinical Trial Yes Registration Number ISRCTN62510577 RCT Yes Subjects Human Ethics Committee West of Scotland Research Ethics Service (Committee 3) Helsinki Yes Informed Consent Yes
Citation

Continence 2S2 (2022) 100404
DOI: 10.1016/j.cont.2022.100404

15/02/2024 16:35:12