To determine the long-term 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.

A 4-year follow-up study of participants from a parallel two-arm, superiority, multicentre randomised controlled trial, which assessed the effectiveness of self-management (SM) compared to clinic-based care (CBC) on prolapse-specific quality of life for women who use a pessary for pelvic organ prolapse. The setting was UK NHS outpatient pessary clinics. The inclusion criteria were age ≥18 years, pessary use of any type/material (except Shelf, Gellhorn or Cube) and retention of a pessary for at least two weeks at entry to the trial. Women were excluded if they had limited manual dexterity, were judged to have a cognitive deficit that prevented informed consent or SM, were pregnant, or would have required the SM teaching in a non-English language. The trial primary endpoint was 18 months post-randomisation(1). Results reported here relate to a questionnaire follow-up at 4 years.

The primary outcome was prolapse-specific quality of life at 4 years, measured using the Pelvic Floor Impact Questionnaire-7 (PFIQ−7)(2), which ranges from 0-300 with higher scores indicating greater impact. Secondary outcomes included participant-reported complications (study-specific Pessary Complications Questionnaire), pessary-specific self-efficacy (study-specific Pessary Confidence Questionnaire), the Pelvic Floor Distress Inventory-20 (PFDI-20)(2) and self-reported health events. 

Women were randomised to either SM or CBC on an even allocation basis. Group allocation was by remote web-based application, with minimisation by age, pessary user type (new /existing) and recruiting centre. Participants, researchers or those delivering the intervention were not blinded to group allocation. 

Women in the SM group received a 30-minute SM teaching appointment, an information leaflet, a two-week follow-up call and a support telephone number for their local centre. Women in the CBC group returned to clinic as advised by the treating health care professional in line with their centre’s usual pessary practice. At 18 months (end of trial) participants’ clinical care reverted to their centre who were responsible for decisions about them remaining on SM, CBC or an alternative.  Women completed a baseline questionnaire and outcome data were collected via follow-up questionnaires at 6, 12, 18- and 48-months post-randomisation. 

Analysis was conducted according to a pre-specified analysis plan. The primary analysis used the intention-to-treat principle. An “on treatment” analysis was also conducted. The PFIQ-7 was summarised using descriptive statistics by group for each time-point and comparisons between randomised groups were made using longitudinal analysis of covariance,  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 by mixed effects models with the same adjustments. 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 about the missing data mechanism. Subgroup analyses of the primary outcome were also conducted (subgroups were age <65 vs ≥65, new vs existing pessary user, hysterectomy vs no hysterectomy, hormone therapy versus no hormone therapy). 

A within-trial economic evaluation was conducted to compare the costs and benefits of SM with CBC over the 48 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.

Participants were recruited between May 2018 and February 2020 at 21 UK centres where pessary care was delivered. The 4-year follow-up took place between June 2022 and September 2023. Of the 340 women originally randomised, 191 opted into the 4-year follow up, with 186 (97%) responding at 4 years (86 SM, 100 CBC). Responders were older, more likely to work part-time, have higher education and report being White British. 

Eighty-seven percent of SM women and 90% of CBC women were still using a pessary at 4 years, with 85% SM vs 80% CBC agreeing or strongly agreeing that their pessary care was acceptable.  Seventy-five percent of SM group had removed and 89% inserted their pessary over the previous 6 months compared to 37% of CBC women removing and 66% inserting their pessary. By 4 years, 85% SM group vs 57% CBC group reported having received SM teaching. A small number had undergone prolapse surgery: 1% (n=1) SM vs 3% (n=3) CBC. 

The PFIQ-7 scores at each time-point are summarised in Table 1 along with the results of the primary analysis. There was no significant difference in PFIQ-7 between groups at 4 years (adjusted mean difference (AMD) 4.86, 95% CI -6.41 to 16.12).  A test of the null hypothesis that the PFIQ-7 scores differed between the groups by the minimal clinically important difference of 20 points concluded that the groups were equivalent. The difference in PFIQ-7 between participants on treatment and not on treatment at 4 years was not significant (AMD 12.49, 95% CI -1.68 to 26.67, p=0.084). The sensitivity analyses and subgroup analyses of the PFIQ-7 data all showed no significant difference between groups.

At 4 years, there was a lower mean proportion of pessary complications (Table 2) in the SM group (AMD ‒3.0%, 95% CI –6.6% to 0.6%) which did not reach statistical significance (p=0.101).   Women in the SM group significantly more often reported that they could manage pessary-related problems (81% vs 73%), and could remove (85% vs 60%) and insert (82% vs 56%) their own pessary. There was no significant difference between groups in the PFDI-20 score at 4 years (AMD -5.07, 95% CI -15.91 to 5.76, p=0.359). There were 24 self-reported hospitalisations, 12 in each group. One in each group was investigated for relatedness to the intervention. Three additional women had unrelated events that were not serious (2 SM, 1 CBC).

Data on health care resources use and EQ-5D-5L were available for 78 SM women and 91 CBC women.  There was no significant difference in the mean number of quality adjusted life years (QALYs) between the groups. Health care resource use was lower in the SM group.

At 4-year follow-up there was no evidence that pessary SM improved prolapse-specific quality of life more than CBC. This finding was corroborated by on-treatment, sensitivity and subgroup analyses. The difference in complications seen at 18 months in favour of the SM group is sustained at 4 years, although no longer statistically significant due to the smaller sample size. Women in the SM group were more self-efficacious about managing their pessary than those in CBC despite a large proportion of women in the CBC group receiving SM training by the 4-year time-point. Pessary SM is a cost-effective intervention in the long-term when compared to CBC.

Pessary self-management is an acceptable intervention in the long-term. It does not improve or worsen women’s quality of life when compared to clinic-based care. SM costs health services less to deliver in the long-term than CBC while decreasing the rate of pessary-related complications. Women who are taught SM maintain a greater level of confidence to manage their pessary than those who originally received CBC.

Hagen, S., Kearney, R., Goodman, K., Best, C., Elders, A., Melone, L., ... & Bugge, C. (2023). Clinical effectiveness of vaginal pessary self-management vs clinic-based care for pelvic organ prolapse (TOPSY): a randomised controlled superiority trial. EClinicalMedicine, 66.
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