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

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^*, Rohna Kearney, Kirsteen Goodman, Lynn Melone, Andrew Elders, Sarkis Manoukian, Wael Agur, Catherine Best, Suzanne Breeman, Melanie Dembinsky, Lucy Dwyer, Mark Forrest, Margaret Graham, Karen Guerrero, Christine Hemming, Aethele Khunda, Helen Mason, Doreen McClurg, John Norrie, Anastasia Karachalia SandriRanee Thakar, Carol Bugge

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

10 Citations (Scopus)

127 Downloads (Pure)

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.

Original language	English
Article number	837
Number of pages	13
Journal	Trials
Volume	21
DOIs	https://doi.org/10.1186/s13063-020-04738-9
Publication status	Published - 8 Oct 2020

Keywords

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

ASJC Scopus subject areas

Pharmacology (medical)
Medicine (miscellaneous)

Documents and Links

10.1186/s13063-020-04738-9

Hagen, S et al (2020) Clinical and cost-effectiveness of vaginal pessary self-management compared to clinicbased care for pelvic organ prolapse: protocol for the TOPSY randomised controlled trial
Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made.
Final published version, 958 KBLicence: CC BY

10 Citations
1 Article

Does self-management of vaginal pessaries improve care for women with pelvic organ prolapse?
Bugge, C., Dembinsky, M., Kearney, R. & Hagen, S., 19 Feb 2021, In: BMJ. 372, 4 p., n310.
Research output: Contribution to journal › Article › peer-review

Open Access
File
13 Citations (Scopus)

309 Downloads (Pure)

Cite this

Hagen, S., Kearney, R., Goodman, K., Melone, L., Elders, A., Manoukian, S., Agur, W., Best, C., Breeman, S., Dembinsky, M., Dwyer, L., Forrest, M., Graham, M., Guerrero, K., Hemming, C., Khunda, A., Mason, H., McClurg, D., Norrie, J., ... Bugge, C. (2020). 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. Trials, 21, Article 837. https://doi.org/10.1186/s13063-020-04738-9

@article{a689c754c6d24bd4accbba44362c6719,

title = "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",

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",

author = "Suzanne Hagen and Rohna Kearney and Kirsteen Goodman and Lynn Melone and Andrew Elders and Sarkis Manoukian and Wael Agur and Catherine Best and Suzanne Breeman and Melanie Dembinsky and Lucy Dwyer and Mark Forrest and Margaret Graham and Karen Guerrero and Christine Hemming and Aethele Khunda and Helen Mason and Doreen McClurg and John Norrie and {Karachalia Sandri}, Anastasia and Ranee Thakar and Carol Bugge",

note = "Acceptance from webpage. AAM req'd 28/4/20 DC - unsure of version, but OA journal; can therefore leave AAM and upload VoR upon publication. 07/05/20 DC Gold exception applied, immediate OA in OA journal. ET 26/10/20 ",

year = "2020",

month = oct,

day = "8",

doi = "10.1186/s13063-020-04738-9",

language = "English",

volume = "21",

journal = "Trials",

issn = "1745-6215",

publisher = "BMC (part of Springer Nature)",

}

Hagen, S, Kearney, R, Goodman, K, Melone, L, Elders, A, Manoukian, S, Agur, W, Best, C, Breeman, S, Dembinsky, M, Dwyer, L, Forrest, M, Graham, M, Guerrero, K, Hemming, C, Khunda, A, Mason, H, McClurg, D, Norrie, J, Karachalia Sandri, A, Thakar, R & Bugge, C 2020, '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', Trials, vol. 21, 837. https://doi.org/10.1186/s13063-020-04738-9

TY - JOUR

T1 - 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

AU - Hagen, Suzanne

AU - Kearney, Rohna

AU - Goodman, Kirsteen

AU - Melone, Lynn

AU - Elders, Andrew

AU - Manoukian, Sarkis

AU - Agur, Wael

AU - Best, Catherine

AU - Breeman, Suzanne

AU - Dembinsky, Melanie

AU - Dwyer, Lucy

AU - Forrest, Mark

AU - Graham, Margaret

AU - Guerrero, Karen

AU - Hemming, Christine

AU - Khunda, Aethele

AU - Mason, Helen

AU - McClurg, Doreen

AU - Norrie, John

AU - Karachalia Sandri, Anastasia

AU - Thakar, Ranee

AU - Bugge, Carol

N1 - Acceptance from webpage. AAM req'd 28/4/20 DC - unsure of version, but OA journal; can therefore leave AAM and upload VoR upon publication. 07/05/20 DC Gold exception applied, immediate OA in OA journal. ET 26/10/20

PY - 2020/10/8

Y1 - 2020/10/8

N2 - 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.

AB - 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.

KW - Economic evaluation

KW - Pessary

KW - Prolapse

KW - Quality of life

KW - Randomised controlled trial (RCT)

KW - Self-management

U2 - 10.1186/s13063-020-04738-9

DO - 10.1186/s13063-020-04738-9

M3 - Article

C2 - 33032644

AN - SCOPUS:85092564638

SN - 1745-6215

VL - 21

JO - Trials

JF - Trials

M1 - 837

ER -

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

Abstract

Keywords

ASJC Scopus subject areas

Documents and Links

Fingerprint

Research output

Does self-management of vaginal pessaries improve care for women with pelvic organ prolapse?

Cite this