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

Suzanne Hagen¹, Rohna Kearney^{2

3}, Kirsteen Goodman⁴, Lynn Melone⁴, Andrew Elders⁴, Sarkis Manoukian⁵, Wael Agur^{6

7}, Catherine Best⁸, Suzanne Breeman⁹, Melanie Dembinsky¹⁰, Lucy Dwyer^{2

3}, Mark Forrest⁹, Margaret Graham¹¹, Karen Guerrero¹², Christine Hemming¹³, Aethele Khunda¹⁴, Helen Mason⁵, Doreen McClurg⁴, John Norrie¹⁵, Anastasia Karachalia-Sandri⁴, Ranee Thakar¹⁶, Carol Bugge¹⁰

Affiliations

¹ Research Unit, Glasgow Caledonian University, Glasgow, UK. S.hagen@gcu.ac.uk.
² The Warrell Unit, St. Mary's Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.
³ University Institute of Human Development, Faculty of Medical Human Sciences, University of Manchester, Manchester, UK.
⁴ Research Unit, Glasgow Caledonian University, Glasgow, UK.
⁵ Yunus Centre for Social Business and Health, Glasgow Caledonian University, Glasgow, UK.
⁶ NHS Ayrshire & Arran, Crosshouse Hospital, Kilmarnock, UK.
⁷ School of Medicine, Dentistry & Nursing, University of Glasgow, Glasgow, UK.
⁸ NMAHP Research Unit, unit 13 Scion House, University of Stirling Innovation Park, Stirling, UK.
⁹ Health Services Research Unit (HSRU), University of Aberdeen, Aberdeen, UK.
¹⁰ Health Sciences & Sport, University of Stirling, Stirling, UK.
¹¹ Patient and Public Involvement (PPI) representative, Dunlop, UK.
¹² Department of Urogynaecology, NHS Greater Glasgow & Clyde, Glasgow, UK.
¹³ Aberdeen Maternity Hospital & Aberdeen Royal Infirmary, Grampian University Hospitals NHS Trust, Aberdeen, UK.
¹⁴ South Tees Hospitals NHS Foundation Trust, James Cook University Hospital, Middlesbrough, UK.
¹⁵ Usher Institute of Population Health Sciences and Informatics, College of Medicine and Veterinary Medicine, The University of Edinburgh, Edinburgh, UK.
¹⁶ Croydon Health Services NHS Trust, Croydon University Hospital, Croydon, UK.

PMID: 33032644
PMCID: PMC7542756
DOI: 10.1186/s13063-020-04738-9

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

Suzanne Hagen et al. Trials. 2020.

. 2020 Oct 8;21(1):837.

doi: 10.1186/s13063-020-04738-9.

Authors

Affiliations

¹ Research Unit, Glasgow Caledonian University, Glasgow, UK. S.hagen@gcu.ac.uk.
² The Warrell Unit, St. Mary's Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.
³ University Institute of Human Development, Faculty of Medical Human Sciences, University of Manchester, Manchester, UK.
⁴ Research Unit, Glasgow Caledonian University, Glasgow, UK.
⁵ Yunus Centre for Social Business and Health, Glasgow Caledonian University, Glasgow, UK.
⁶ NHS Ayrshire & Arran, Crosshouse Hospital, Kilmarnock, UK.
⁷ School of Medicine, Dentistry & Nursing, University of Glasgow, Glasgow, UK.
⁸ NMAHP Research Unit, unit 13 Scion House, University of Stirling Innovation Park, Stirling, UK.
⁹ Health Services Research Unit (HSRU), University of Aberdeen, Aberdeen, UK.
¹⁰ Health Sciences & Sport, University of Stirling, Stirling, UK.
¹¹ Patient and Public Involvement (PPI) representative, Dunlop, UK.
¹² Department of Urogynaecology, NHS Greater Glasgow & Clyde, Glasgow, UK.
¹³ Aberdeen Maternity Hospital & Aberdeen Royal Infirmary, Grampian University Hospitals NHS Trust, Aberdeen, UK.
¹⁴ South Tees Hospitals NHS Foundation Trust, James Cook University Hospital, Middlesbrough, UK.
¹⁵ Usher Institute of Population Health Sciences and Informatics, College of Medicine and Veterinary Medicine, The University of Edinburgh, Edinburgh, UK.
¹⁶ Croydon Health Services NHS Trust, Croydon University Hospital, Croydon, UK.

PMID: 33032644
PMCID: PMC7542756
DOI: 10.1186/s13063-020-04738-9

Abstract

Background: Pelvic 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.

Methods: This 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 registration: ISRCTN Registry ISRCTN62510577 . Registered on June 10, 2017.

Keywords: Economic evaluation; Pessary; Prolapse; Quality of life; Randomised controlled trial (RCT); Self-management.

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References

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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

Affiliations

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

Authors

Affiliations

Abstract

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Miscellaneous