TOPSY: Pessary Self-Management versus Clinic-Based Care for Pelvic Organ Prolapse
TOPSY was a multicenter, open-label superiority randomized trial in 340 women at 21 UK National Health Service pessary clinics who had retained a pessary for at least 2 weeks, comparing taught self-management with routine clinic-based care; the clinical primary endpoint was the Pelvic Floor Impact Questionnaire-7 (PFIQ-7) at 18 months and the economic primary endpoint was incremental net benefit. PFIQ-7 did not differ (32.3 versus 32.5; adjusted difference −0.03, 95% CI −9.32 to 9.25), and self-management had a lower mean cost (£578.30 versus £728.84 per participant), with an incremental net benefit of £564.32.[1]
- Design and population
- Multicenter, open-label, parallel-group superiority randomized trial. 340 women aged 18 or older at 21 UK National Health Service pessary clinics who had retained a pessary (not shelf, Gellhorn or cube) for at least 2 weeks.
- Arms
- Pessary self-management versus clinic-based pessary care
- Report and follow-up
- 2023 · 18 months after randomization (follow-up completed 17 September 2021)
| Endpoint | Results | Effect | Finding |
|---|---|---|---|
| Pelvic Floor Impact Questionnaire-7 total score at 18 months (range 0 to 300, higher is worse), intention to treat; adjusted mean difference, self-management minus clinic-based care | 32.3 (SD 50.9; n=139) vs 32.5 (SD 47.8; n=152) | difference -0.03; 95% CI -9.32–9.25 | Not met |
| Incremental net benefit of self-management over 18 months at a willingness to pay of £20,000 per QALY (health-sector perspective, 2019 prices) | Total cost £578.30; 1.241 QALYs vs Total cost £728.84; 1.221 QALYs | difference 564.32; 95% CI -576–1704 | Met |
Harms: Serious adverse events: 17/169 vs 14/171; Difficulty emptying bladder: 25/141 (17.7%) vs 41/147 (27.9%); Difficulty emptying bowels: 34/140 (24.3%) vs 55/151 (36.4%)
ISRCTN62510577 · Report DOI
Design
Eligible women were 18 or older and used a pessary of any material or type except shelf, Gellhorn or cube, retained for at least 2 weeks; new users (3 months or less of use) and existing users were both included. Women with limited manual dexterity, a cognitive deficit that precluded consent or self-management, pregnancy, or insufficient English (the teaching was available only in English) were excluded. Allocation was 1:1 by a web-based system, minimized on age (under 65 or 65 and older), user type and centre. Participants, intervention deliverers, researchers and the statistician were not masked.[1]
Of 2514 women screened between 16 May 2018 and 7 February 2020, 340 were randomized. Randomized women were younger (64 versus 67 years) and less often existing users (68% versus 80%) than eligible women who did not take part, and 39% of those who declined randomization had a treatment preference (33% for clinic-based care, 6% for self-management). Baseline groups were similar: mean age 63.7 years, 106 of 340 (31.2%) new users, and a ring pessary in about 88% of each arm.[1]
The sample size of 330 gave 90% power to detect a 20-point PFIQ-7 difference at 18 months (standard deviation 50, two-sided alpha 0.05, 20% loss to follow-up). The 20 points came from consensus among patient representatives and clinical collaborators, since no minimal clinically important difference had been published for this population. PFIQ-7 ranges from 0 to 300, with higher scores indicating worse pelvic floor-specific quality of life. The economic primary endpoint was incremental net benefit at £20,000 per quality-adjusted life-year (QALY) from a health-sector perspective, where a positive value implies self-management is cost-effective. Analysis was by intention to treat with a longitudinal analysis of covariance adjusted for age group, user type and baseline PFIQ-7.[1]
Results
At 18 months, valid PFIQ-7 data were available for 139 of 169 self-management women (82.2%) and 152 of 171 clinic-care women (88.9%). Mean scores were 32.3 and 32.5; the adjusted difference of −0.03 (95% CI −9.32 to 9.25) did not show superiority, and the interval excludes the 20-point difference the trial was powered to detect. Differences at 6 months (−5.90, 95% CI −15.00 to 3.20) and 12 months (−3.45, 95% CI −12.71 to 5.82) were also nonsignificant. Sensitivity analyses for missing data, crossover and previous hysterectomy, and subgroups defined by age, user type, hysterectomy and local oestrogen use, gave no significant difference.[1]
Over 18 months, mean total cost was £578.30 with self-management and £728.84 with clinic-based care, and QALYs were 1.241 and 1.221. The incremental net benefit of £564.32 (standard error £581.50; 95% CI −£576 to £1704) was positive, which met the trial's criterion for cost-effectiveness, although the interval includes zero. Mean pessary-related clinic-visit cost was £16.81 versus £77.45 per participant, and the teaching appointment cost a mean £31.77. Among 125 self-management and 139 clinic-care women with EQ-5D-5L data, mean index scores at 18 months were 0.823 and 0.819.[1]
Self-managing women reported a lower mean percentage of applicable complication types (16.7% versus 22.0%; adjusted difference −3.83, 95% CI −6.86 to −0.81), more often rated their pessary care as better (42 of 126, 33.3%, versus 35 of 143, 24.5%), and were more confident inserting (81.28 versus 48.36) and removing (85.28 versus 52.63) the pessary; the adjusted odds ratio from ordinal regression across PGI-I response categories was 3.23 (95% CI 1.47 to 7.13). General self-efficacy (31.3 versus 32.0) and PFDI-20 (98.07 versus 102.04) did not differ.[1]
The 4-year report followed participants who opted in: 186 of 340 (55%) responded, 86 of 169 self-management (51%) and 100 of 171 clinic-care women (58%). Mean PFIQ-7 was 32.9 versus 31.4 (adjusted difference 4.86, 95% CI −6.41 to 16.12; p = 0.398). An equivalence test added after the null 18-month result rejected a 20-point difference (p = 0.0108). The incremental net benefit was £2240.15 (bootstrapped standard error £1530.25), with a probability of cost-effectiveness of 92.97% at £20,000 per QALY, based on 78 self-management and 91 clinic-care women with complete data. At 4 years, the mean percentage of applicable complication types reported per participant was 17.91% versus 21.97% (reported adjusted difference 3.01, 95% CI −0.58 to 6.61; p = 0.101). Confidence to insert (82.3 versus 55.9) and remove (85.5 versus 59.6) the pessary remained higher with self-management.[2]
Surgery and treatment delivery
Self-management consisted of a 30-minute appointment in which the woman removed, cleaned and reinserted her own pessary under supervision, an information leaflet, a telephone call at 2 weeks and a clinic number for support. Each centre's specialist nurse, physiotherapist or doctor was trained at a site visit and given a manual. Clinic-based care followed local practice, usually every 6 months; excluding COVID-19 lockdown periods, the median change interval was 186 days (interquartile range 165 to 201).[1]
Pessary type at baseline was a ring in 148 of 168 self-management women (88.1%) and 151 of 171 clinic-care women (88.3%); silicone devices were used in 54 of 167 (32.3%) and 52 of 167 (31.1%), and PVC in 90 of 167 (53.9%) and 98 of 167 (58.7%). Mean pessary size was 71.0 and 70.7 mm. Local oestrogen was used by 98 of 340 women (28.8%), 38 (11.2%) had a previous hysterectomy and 39 (11.5%) previous pelvic floor surgery.[1]
By 18 months, 141 of 169 self-management women (83.4%) were classed as on treatment, against 103 of 171 clinic-care women (60.2%) classed as on treatment in that arm. Thirty-four self-management women (20.1%) had changed to clinic-based care, including 11 who could not remove the pessary. No clinic-care woman formally crossed over, but of 55 who said they had removed their pessary, 27 (49%) reported receiving self-management training. Pessary use had stopped in 16 of 169 and 26 of 171 women. Intention to continue was 130 of 138 (94.2%) with self-management and 131 of 148 (88.5%) with clinic-based care, and 101 of 134 (75.4%) versus 92 of 143 (64.3%) found pessary changes convenient.[1]
At 4 years, 79 of 86 self-management and 94 of 100 clinic-care responders had used a pessary in the previous 6 months. Among those currently using a pessary, 60 of 75 original self-management women (80%) still self-managed, while 35 of 90 original clinic-care women (39%) had changed to self-management. Eight responders (4%) had any surgery: 4 prolapse operations (1 self-management, 3 clinic-care), 1 incontinence operation and 3 hysterectomies.[2]
Adverse events
Serious adverse events occurred in 17 of 169 self-management and 14 of 171 clinic-care women, all judged unrelated to trial participation, and there were no suspected unexpected serious adverse reactions. Between 18 months and 4 years, 11 self-management and 8 clinic-care women reported serious adverse events; one event in the self-management group, urinary and chest infections requiring hospitalization, was possibly related.[1][2]
Participant-reported complications at 18 months, self-management versus clinic-based care, were difficulty emptying the bladder 25 of 141 (17.7%) versus 41 of 147 (27.9%), difficulty emptying the bowels 34 of 140 (24.3%) versus 55 of 151 (36.4%), pessary falling out 6 of 138 (4.3%) versus 19 of 145 (13.1%) and difficulty having sex 5 of 134 (3.7%) versus 16 of 148 (10.8%). Vaginal discharge (29.1% versus 32.5%), smell (18.4% versus 22.0%), non-menstrual bleeding (10.9% versus 14.7%) and urine infection (12.1% versus 10.6%) were similar. On examination, ulceration, granulation or another vaginal tissue concern was found in 27 of 152 (17.8%) and 43 of 160 (26.9%).[1]
At 18 months, 15 of 140 self-management women (10.7%) versus 11 of 150 clinic-care women (7.3%) reported being unable to remove the pessary, and 27 of 139 (19.4%) versus 12 of 149 (8.1%) reported difficulty removing it.[1] Of the 15 who could not remove it, 11 had reverted to clinic-based care. At 4 years the same items were 5 of 86 (5.8%) versus 4 of 100 (4.0%) and 14 of 85 (16.5%) versus 9 of 98 (9.2%), while difficulty emptying the bladder (12 of 85, 14.1%, versus 27 of 98, 27.6%) and difficulty having sex (1 of 84, 1.2%, versus 9 of 97, 9.3%) again favored self-management.[1][2]
Limitations
Participants and clinicians were unmasked, and the primary outcome, the complication outcome and the confidence outcomes were participant-reported. Complications came from a 15-item study-specific questionnaire, and the authors call for a validated pessary complications instrument. Response at 18 months was lower with self-management (82.2% versus 88.9%), and 20.1% of self-management women changed to clinic-based care while some clinic-care women self-managed, which the authors note could dilute the intention-to-treat contrast; the on-treatment analysis agreed with it.[1] Both arms used a pessary, so the trial compares two ways of delivering the same device, and about 91% of participants were White.[1] Women who agreed to randomization were younger and less often existing users than those who declined. The 4-year report rests on 55% of the cohort who opted in, and the authors suggest the loss of power may explain the nonsignificant complications difference.[1][2]
In conversation
Same setting PESSRI (2007)
Report history
| Published | Report | Cutoff | Headline results | Citation |
|---|---|---|---|---|
| 2023-11-23 | 18-month report · primary | — | Pelvic Floor Impact Questionnaire-7 total score at 18 months (range 0 to 300, higher is worse), intention to treat; adjusted mean difference, self-management minus clinic-based care: 32.3 (SD 50.9; n=139) vs 32.5 (SD 47.8; n=152); difference -0.03; 95% CI -9.32–9.25 Not met Incremental net benefit of self-management over 18 months at a willingness to pay of £20,000 per QALY (health-sector perspective, 2019 prices): Total cost £578.30; 1.241 QALYs vs Total cost £728.84; 1.221 QALYs; difference 564.32; 95% CI -576–1704 Met PFIQ-7 at 6 months, adjusted mean difference, self-management minus clinic-based care: 22.7 (SD 36.7; n=149) vs 29.4 (SD 47.7; n=157); difference -5.9; 95% CI -15–3.2 PFIQ-7 at 12 months, adjusted mean difference, self-management minus clinic-based care: 30.3 (SD 52.0; n=144) vs 33.1 (SD 53.3; n=148); difference -3.45; 95% CI -12.71–5.82 Mean percentage of applicable complication types reported per participant at 18 months (13 of 15 study-specific items), adjusted mean difference, self-management minus clinic-based care: 16.7% (SD 13.2; n=142) vs 22.0% (SD 17.3; n=152); difference -3.83; 95% CI -6.86–-0.81 Ulceration, granulation or other clinical concern on vaginal examination at 18 months: 27/152 (17.8%) vs 43/160 (26.9%); — Perception of pessary care as better (PGI-I) at 18 months; adjusted odds ratio from ordinal regression: 42/126 (33.3%) vs 35/143 (24.5%); OR 3.23; 95% CI 1.47–7.13 Confidence to insert the pessary at 18 months (study-specific 0 to 100 scale); adjusted mean difference: 81.28 (SD 33.31; n=142) vs 48.36 (SD 37.74; n=152); difference 32.78; 95% CI 25.1–40.45 Confidence to remove the pessary at 18 months (study-specific 0 to 100 scale); adjusted mean difference: 85.28 (SD 30.24; n=142) vs 52.63 (SD 38.63; n=152); difference 32.92; 95% CI 25.19–40.64 General Self-Efficacy Scale at 18 months (range 10 to 40); adjusted mean difference: 31.3 (SD 5.4; n=132) vs 32.0 (SD 4.0; n=143); difference -0.77; 95% CI -1.69–0.14 Pelvic Floor Distress Inventory-20 at 18 months (range 0 to 300); adjusted mean difference: 98.07 (SD 47.13; n=142) vs 102.04 (SD 52.05; n=152); difference 0.55; 95% CI -8.08–9.17 EQ-5D-5L index score at 18 months (analysis sample); Mann-Whitney test: 0.823 (SD 0.190; n=125) vs 0.819 (SD 0.188; n=139); P 0.856 | Hagen S, Kearney R, Goodman K, et al. Clinical effectiveness of vaginal pessary self-management vs clinic-based care for pelvic organ prolapse (TOPSY): a randomised controlled superiority trial. *EClinicalMedicine.* 2023;66:102326. DOI |
| 2025-08-20 | 4-year follow-up · updated | — | PFIQ-7 total score at 4 years, intention to treat; adjusted mean difference, self-management minus clinic-based care: 32.9 (SD 56.6; n=86) vs 31.4 (SD 52.5; n=100); difference 4.86; 95% CI -6.41–16.12; P 0.398 Not met Equivalence test at 4 years against the 20-point minimal clinically important difference (added because the 18-month result was null): The null hypothesis of a 20-point difference was rejected (t[184] = 2.317).; P 0.0108 Incremental net benefit of self-management at 4 years at a willingness to pay of £20,000 per QALY (health-sector perspective, 2019/2020 prices): Total cost £976.74; 3.268 QALYs (n=78) vs Total cost £1215.80; 3.168 QALYs (n=91); difference 2240.15 Met Mean percentage of applicable complication types reported per participant over the previous 6 months at 4 years; adjusted mean difference (positive when the self-management rate is lower): 17.91% (SD 15.66; n=86) vs 21.97% (SD 17.14; n=100); difference 3.01; 95% CI -0.58–6.61; P 0.101 PFDI-20 at 4 years; adjusted mean difference: 94.3 (SD 55.7; n=86) vs 102.8 (SD 53.5; n=100); difference -5.07; 95% CI -15.91–5.76 Perception of pessary care as better (PGI-I) at 4 years; odds ratio from ordinal regression: 29/85 (34.1%) vs 28/99 (28.3%); OR 1.01; 95% CI 0.59–1.7 Confidence to insert the pessary at 4 years; adjusted mean difference: 82.3 (SD 32.6; n=86) vs 55.9 (SD 40.7; n=99); difference 26.56; 95% CI 16–37.12 Confidence to remove the pessary at 4 years; adjusted mean difference: 85.5 (SD 29.5; n=86) vs 59.6 (SD 39.7; n=99); difference 26.21; 95% CI 16.13–36.29 Currently using a pessary at 4 years among responders: 75/86 (87.2%) vs 90/100 (90.0%); — Descriptive Prolapse surgery between randomization and 4 years among responders: 1 vs 3; — Descriptive | Bugge C, Kearney R, Best C, et al. Four year clinical and cost effectiveness of vaginal pessary self-management versus clinic-based care for pelvic organ prolapse (TOPSY): long term follow-up of a randomised controlled superiority trial. *BJOG.* 2025;132(12):1762-1771. DOI |
References
1. Hagen S, Kearney R, Goodman K, et al. "Clinical effectiveness of vaginal pessary self-management vs clinic-based care for pelvic organ prolapse (TOPSY): a randomised controlled superiority trial." EClinicalMedicine. 2023;66:102326. doi:10.1016/j.eclinm.2023.102326
2. Bugge C, Kearney R, Best C, et al. "Four year clinical and cost effectiveness of vaginal pessary self-management versus clinic-based care for pelvic organ prolapse (TOPSY): long term follow-up of a randomised controlled superiority trial." BJOG. 2025;132(12):1762-1771. doi:10.1111/1471-0528.18333