Related Experiment Video
Updated: Dec 6, 2025
03:30
Author Spotlight: Advancing Pelvic Prolapse Treatment with a Non-Mesh Approach using Laparoscopic Pectopexy
Published on: October 25, 2024
2.1K
The TOPSY pessary self-management intervention for pelvic organ prolapse: a study protocol for the process evaluation
Carol Bugge1, Rohna Kearney2,3, Melanie Dembinsky4
1Faculty of Health Sciences and Sport, University of Stirling, Stirling, UK. carol.bugge@stir.ac.uk.
Trials
|October 9, 2020
Summary
This study evaluates pessary self-management versus clinic care for women with pelvic organ prolapse. Process evaluation examines recruitment, fidelity, and experiences to inform implementation strategies for better women's health outcomes.
Area of Science:
- Urogynecology and women's health research.
- Health services research and complex intervention evaluation.
Background:
- Process evaluations are crucial for understanding complex health intervention implementation in real-world settings.
- The TOPSY study includes a randomized controlled trial and a nested process evaluation on pessary self-management versus clinic care.
- The process evaluation focuses on optimizing trial recruitment, assessing intervention fidelity, and exploring participant and healthcare professional experiences.
Purpose of the Study:
- To compare the effectiveness of pessary self-management with clinic-based care for women's quality of life.
- To examine and maximize recruitment into the TOPSY trial.
- To describe intervention fidelity and explore patient and healthcare professional experiences with pessary care.
Main Methods:
- A mixed-methods approach involving semi-structured interviews with randomized women, non-randomized women, and healthcare professionals.
- Recording of recruitment discussions, self-management teaching appointments, and follow-up calls.
- Quantitative and qualitative process data collected via participant questionnaires, with thematic analysis for interviews and analytic grids for recordings.
Main Results:
- The study acknowledges the diverse pessary care contexts across the UK, influencing intervention implementation.
- Including non-randomized women offers novel insights into trial non-participation and generalizability.
- Analysis of recruitment processes provides methodological insights for future trial recruitment strategies.
Conclusions:
- Understanding the localized contexts of pessary care is vital for implementing self-management strategies effectively.
- The inclusion of non-randomized participants enhances the contextualization and generalizability of findings.
- Insights into recruitment processes can inform future study designs and recruitment strategies for similar interventions.
