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

IF 4.3 1区医学 Q1 OBSTETRICS & GYNECOLOGY

Bjog-An International Journal of Obstetrics and Gynaecology Pub Date : 2025-08-20 DOI:10.1111/1471-0528.18333

Carol Bugge, Rohna Kearney, Catherine Best, Kirsteen Goodman, Sarkis Manoukian, Lynn Melone, Melanie Dembinsky, Helen Mason, Andrew Elders, Margaret Graham, Wael Agur, Suzanne Breeman, Jane Culverhouse, Lucy Dwyer, Mark Forrest, Karen Guerrero, Christine Hemming, Aethele Khunda, Angela Kucher, Doreen McClurg, John Norrie, Ranee Thakar, Suzanne Hagen

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引用次数: 0

Abstract

Objective

To compare long-term clinical and cost-effectiveness of pessary self-management (SM) with clinic-based care (CBC) for pelvic floor-specific quality of life (QoL).

Design

Four-year questionnaire follow-up of trial participants.

Setting

UK pessary clinics.

Sample

Responders at 4 years aged ≥ 18 years at recruitment, using a pessary (except Shelf, Gellhorn or Cube) which had been retained ≥ 2 weeks. Exclusions: limited manual dexterity; cognitive deficit; pregnancy; requiring non-English SM teaching.

Methods

SM group received a 30-min teaching session; information leaflet; 2-week follow-up call; and telephone support. CBC group received routine appointments. Allocation was by remote web-based application, minimised on age, user type (new/existing) and centre with no blinding. Participants were invited to opt into a 4-year follow-up. The primary analysis was intention to treat.

Outcome Measures

The primary outcomes were pelvic floor-specific QoL (PFIQ-7) and incremental net monetary benefit (INB) 4 years post-randomisation. Secondary outcomes included complications and prolapse symptoms.

Results

Of 340 women randomised, 186 (55%) responded at 4 years (86/169 [51%] SM, 100/171 [58%] CBC). There was no statistically significant group difference in PFIQ-7 at 4 years (mean SM 32.9 vs. CBC 31.4, adjusted mean difference [AMD] SM-CBC 4.86, 95% CI −6.41 to 16.12). There was a statistically non-significant lower percentage of pessary complications for SM (SM 17.7% vs. CBC 22.0%, AMD 3.01 CI −0.58 to 6.61). At 4-years, SM was cost-effective (INB £2240). There was one potentially related serious adverse event (SM group).

Conclusions

Pessary self-management is an effective and cost-effective long-term option for women with prolapse.

Trial Registration

ISRCTN number: 62510577 (https://doi.org/10.1186/ISRCTN62510577)

Abstract Image

查看原文本刊更多论文

阴道阴道自我管理与盆腔器官脱垂（TOPSY）临床护理的四年临床和成本效益：一项随机对照优势试验的长期随访。

目的：比较盆底自我管理（SM）与临床护理（CBC）对盆底特异性生活质量（QoL）的长期临床和成本效益。设计：对试验参与者进行为期四年的问卷随访。环境：英国必要的诊所。样本：招募时年龄≥18岁的4岁应答者，使用保留≥2周的托具（Shelf、Gellhorn或Cube除外）。排除：有限的手工灵巧性；认知赤字;怀孕;要求非英语SM教学。方法：SM组给予30 min的教学时间；信息传单;2周随访电话；还有电话支持。CBC组接受常规预约。分配是通过远程基于网络的应用程序，最小化年龄，用户类型（新/现有）和中心，没有盲法。参与者被邀请参加为期4年的随访。主要分析是治疗意向。结果测量：主要结果是随机分组后4年盆底特异性生活质量（PFIQ-7）和增量净货币效益（INB）。次要结局包括并发症和脱垂症状。结果：在340名随机分组的女性中，186名（55%）在4年时有反应（86/169 [51%]SM, 100/171 [58%] CBC）。4年PFIQ-7组间差异无统计学意义（SM均值32.9 vs CBC均值31.4，调整后平均差异[AMD] SM-CBC均值4.86,95% CI -6.41 ~ 16.12）。SM的必要并发症发生率较SM低（SM 17.7% vs CBC 22.0%, AMD 3.01 CI -0.58 ~ 6.61），统计学上无显著性差异。在4年的时间里，SM是划算的（2240英镑）。有一个潜在的相关严重不良事件（SM组）。结论：子宫内膜自我管理对脱垂妇女是一种有效且经济的长期选择。试验注册：ISRCTN号：62510577 （https://doi.org/10.1186/ISRCTN62510577）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Bjog-An International Journal of Obstetrics and Gynaecology 医学-妇产科学

CiteScore

10.90

自引率

5.20%

发文量

345

审稿时长

3-6 weeks

期刊介绍： BJOG is an editorially independent publication owned by the Royal College of Obstetricians and Gynaecologists (RCOG). The Journal publishes original, peer-reviewed work in all areas of obstetrics and gynaecology, including contraception, urogynaecology, fertility, oncology and clinical practice. Its aim is to publish the highest quality medical research in women''s health, worldwide.