Administrative information
Title {1} | 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 |
Trial registration {2a and 2b}. | ISRCTN Registry; ISRCTN62510577, registered on 06/10/2017 |
Protocol version {3} | Protocol Version 5. 25th July 2019 |
Funding {4} | This study is funded by the National Institute for Health Research Evaluation, Trials and Studies Coordinating Centre, Health Technology Assessment (NETSCC HTA) Programme (ref 16/82/01). |
Author details {5a} | Suzanne Hagena, Rohna Kearneyb, Kirsteen Goodmana, Lynn Melonea, Andrew Eldersa, Sarkis Manoukianc, Wael Agurd, Catherine Beste, Suzanne Breemanf, Melanie Dembinskyl, Lucy Dwyerb, Mark Forrestf, Margaret Graham, Karen Guerrerog, Christine Hemmingh, Aethele Khundai, Helen Masonc, Doreen McClurga, John Norriej, Anastasia Karachalia-Sandria, Ranee Thakark, and Carol Buggel a NMAHP Research Unit, Glasgow Caledonian University b The Warrell Unit, St. Mary’s Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre; University Institute of Human Development, Faculty of Medical Human Sciences, University of Manchester c Yunus Centre for Social Business and Health, Glasgow Caledonian University d NHS Ayrshire & Arran, Crosshouse Hospital; School of Medicine, Dentistry & Nursing, University of Glasgow eNMAHP Research Unit, unit 13 Scion House, University of Stirling Innovation Park, Stirling f Health Services Research Unit (HSRU), University of Aberdeen g Department of Urogynaecology, NHS Greater Glasgow & Clyde h Grampian University Hospitals NHS Trust, Aberdeen Maternity Hospital & Aberdeen Royal Infirmary i South Tees Hospitals NHS Foundation Trust, James Cook University Hospital j Usher Institute of Population Health Sciences and Informatics, College of Medicine and Veterinary Medicine, The University of Edinburgh k Croydon Health Services NHS Trust, Croydon University Hospital, Croydon l Health Sciences & Sport, University of Stirling |
Name and contact information for the trial sponsor {5b} | University of Stirling Stirling FK9 4LA |
Role of sponsor {5c} | The Sponsor played no part in study design; collection, management, analysis and interpretation of data; writing of the protocol and the decision to submit the report for publication. |
Background and rationale {6a}
Objectives {7}
Methods
Trial design {8}
Study setting {9}
Eligibility criteria {10}
Recruitment {15}
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Assignment of interventions
Sequence generation {16a}
Concealment mechanism {16b}
Implementation {16c}
Who will be blinded? {17a}
Procedure for unblinding if needed {17b}
Intervention description {11a}
Pessary self-management
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At a service level to facilitate a supportive culture for a self-management treatment pathway.
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At a professional level to ensure that staff have the self-management teaching and support skills.
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At an individual woman level to ensure women can achieve the necessary tasks to self-manage.
Supporting delivery of self-management at service and professional levels
Intervention components delivered to individual women
Strategies to improve adherence to interventions {11c}
Provisions for post-trial care {30}
Criteria for discontinuing or modifying allocated interventions {11b}
Relevant concomitant care permitted or prohibited during the trial {11d}
Explanation for the choice of comparators {6b}—clinic-based pessary care
Recruitment and retention of study centres
Outcomes {12}
Plans for assessment and collection of outcomes {18a}
Primary outcome
Secondary outcome measures
Pessary complications
Pessary use
Pessary confidence (to measure pessary-specific self-efficacy)
Uptake of additional treatment for prolapse
Uptake of telephone support related to pessary use
Adherence to randomised protocol
Health of vaginal tissues
Biological specimens {33}
Data collection for economic evaluation
Plans to promote participant retention and complete follow-up {18b}
Data management {19}
Sample size {14}
Stopping guidelines {21b}
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If the overall recruitment rate across pilot centres is 75% or more of the total expected recruitment (i.e. at least 47 out of 63), the trial will continue.
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If the recruitment rate is 50–75% (31–46 women), the trial will continue with a clear plan to overcome barriers to recruitment that is based on review of screening logs at centres, the trial protocol and the qualitative recruitment data (process evaluation).
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If the recruitment rate is 25–50% (16–30 women), screening logs, the protocol and the qualitative recruitment data (process evaluation) will be reviewed and the trial will only continue after discussion with and approval by NIHR HTA and with a clear plan to recruit within more centres and address the recruitment shortfall.
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Should recruitment be < 25% (15 women or less), we will enter into discussions with the funder but it is not expected the trial will progress. The decision to stop the trial will be made by the TSC and the funder.
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40% of eligible new and 20% of eligible existing pessary users invited agree to randomisation;
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60% of the pilot self-management women (n = 19 of 31 women randomised to self-management) still self-managing at 2-week telephone follow-up (i.e. have removed and re-inserted their pessary at least once).
Statistical methods for primary and secondary outcomes {20a}
Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}
Methods for additional analyses {20b}
Economic analysis
Cost-effectiveness analysis
Longer-term decision modelling
Interim analyses {21b}
Composition of the coordinating centre and trial steering committee {5d} and composition of the data monitoring committee, its role and reporting structure {21a}
Frequency and plans for auditing trial conduct {23}
Adverse event reporting and harms {22}
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Granulation of vaginal tissue
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Involuntary expulsion of pessary
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Vaginal smell
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Vaginal discharge
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Bleeding during pessary change.