Pessary self-management improves QoL and compliance among patients with pelvic organ prolapse
Although no randomized trials have evaluated pessary self-management, non-randomized studies have shown that self-management is associated with higher levels of convenience, access to help and support, lower adverse event rates, and a greater likelihood of continuing pessary use. However, the effectiveness of self-management has yet to be evaluated.
A study published in eClinicalMedicine found that self-managed women and clinic-based pessary care had a comparable quality of life, with fewer complications and less healthcare resource use and cost. These findings support offering self-management to women who can, which could decrease healthcare resource use and reduce pessary complications.
Prolapse affects 30-40% of women. Those using a pessary for prolapse usually receive outpatient care. This trial compared the effectiveness and cost-effectiveness of pessary self-management versus clinic-based care (SM vs CBC) about condition-specific quality of life (QoL).
Parallel-group, superiority RCT recruiting from 16 May 2018 to 7 February 2020, with follow-up to 17 September 2021. Eligible women: ≥18 years old, using pessary (except Shelf, Gellhorn, or Cube) retained ≥2 weeks. Exclusions included limited manual dexterity, cognitive deficit, pregnancy, and non-English teaching. SM group received 30-minute teaching, an info leaflet, a 2-week follow-up call, and telephone support. CBC group received routine appointments. The primary outcome was Pelvic floor-specific QoL (PFIQ-7) and incremental net monetary benefit for cost-effectiveness 18 months post-randomization. The allocation was done by a remote web-based app based on age, user type, and centre.
Study findings include:
· The requisite 340 women were randomized: 169 in SM and 171 in CBC across 21 centres.
· At 18 months, there was no statistically significant difference between groups in PFIQ-7 (mean SM 32.3 vs CBC 32.5). The adjusted mean difference SM-CBC is −0.03.
· Compared to CBC, SM was less costly.
· The incremental net benefit of SM was £564.
· The SM group had a lower percentage of pessary complications. The mean SM vs CBC was 16.7% vs 22.0%. The adjusted mean difference was −3.83.
· There was no meaningful difference in general self-efficacy.
· Self-managing women were more confident in self-management activities.
· There were no reported suspected unexpected serious adverse reactions and 31 unrelated serious adverse events (17 SM, 14 CBC).
This study compared pessary self-management with clinic-based care for prolapse management, providing the first randomized evidence on effectiveness and cost-effectiveness to guide practice and service provision. The trial showed comparable quality of life for both groups, with fewer complications and lower healthcare resource use and cost. These findings support offering self-management to women who can do so.
Reference:
Hagen, S. et al. Clinical effectiveness of vaginal pessary self-management vs clinic-based care for pelvic organ prolapse (TOPSY): a randomized controlled superiority trial. EClinicalMedicine, 66, 102326. https://doi.org/10.1016/j.eclinm.2023.102326
