ArticleTrials2020
Clinical and cost-effectiveness of vaginal pessary self-management compared to clinic-based care for pelvic organ prolapse: protocol for the TOPSY randomised controlled trial.
Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.
- Do vaginal pessaries used to treat pelvic organ prolapse impact on sexual function? A systematic review and meta-analysis.International urogynecology journal · 2022Pooled it
- Self-management of vaginal pessaries for pelvic organ prolapse: multi-method process evaluation, linked to the TOPSY randomised controlled trial.BMC medicine · 2025Trial
- 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 : an international journal of obstetrics and gynaecology · 2025Trial
- Clinical and cost-effectiveness of pessary self-management versus clinic-based care for pelvic organ prolapse in women: the TOPSY RCT with process evaluation.Health technology assessment (Winchester, England) · 2024Trial
- Trial
- Understanding Factors That Affect Willingness to Self-Manage a Pessary for Pelvic Organ Prolapse: A Questionnaire-Based Cross-Sectional Study of Pessary-Using Women in the UK.International urogynecology journal · 2024Article
- Adherence to support pessary in the treatment of pelvic organ prolapse: a retrospective study conducted among 1,371 women.International urogynecology journal · 2024Article
- Clinical effectiveness of vaginal pessary self-management vs clinic-based care for pelvic organ prolapse (TOPSY): a randomised controlled superiority trial.EClinicalMedicine · 2023Article
- What is known from the existing literature about self-management of pessaries for pelvic organ prolapse? A scoping review.BMJ open · 2022Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
22 authors at 10 institutions in 1 country.
Funding
Abstract
backgroundPelvic organ prolapse (or prolapse) is a common condition in women where the pelvic organs (bladder, bowel or womb) descend into the vagina and cause distressing symptoms that adversely affect quality of life. Many women will use a vaginal pessary to treat their prolapse symptoms. Clinic-based care usually consists of having a pessary fitted in a primary or secondary care setting, and returning approximately every 6 months for healthcare professional review and pessary change. However, it is possible that women could remove, clean and re-insert their pessary themselves; this is called self-management. This trial aims to assess if self-management of a vaginal pessary is associated with better quality of life for women with prolapse when compared to clinic-based care.
methodsThis is a multicentre randomised controlled trial in at least 17 UK centres. The intervention group will receive pessary self-management teaching, a self-management information leaflet, a follow-up phone call and access to a local telephone number for clinical support. The control group will receive the clinic-based pessary care which is standard at their centre. Demographic and medical history data will be collected from both groups at baseline. The primary outcome is condition-specific quality of life at 18 months' post-randomisation. Several secondary outcomes will also be assessed using participant-completed questionnaires. Questionnaires will be administered at baseline, 6, 12 and 18 months' post-randomisation. An economic evaluation will be carried out alongside the trial to evaluate cost-effectiveness. A process evaluation will run parallel to the trial, the protocol for which is reported in a companion paper. DISCUSSION: The results of the trial will provide robust evidence of the effectiveness of pessary self-management compared to clinic-based care in terms of improving women's quality of life, and of its cost-effectiveness.
trial registrationISRCTN Registry ISRCTN62510577 . Registered on June 10, 2017.
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What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.