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

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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

prolapse
pessary
self-management
quality of life
economic evaluation
randomised controlled trial (RCT)

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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
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Final published version, 958 KBLicence: CC BY

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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, [837]. https://doi.org/10.1186/s13063-020-04738-9

Hagen, Suzanne ; Kearney, Rohna ; Goodman, Kirsteen ; Melone, Lynn ; Elders, Andrew ; Manoukian, Sarkis ; Agur, Wael ; Best, Catherine ; Breeman, Suzanne ; Dembinsky, Melanie ; Dwyer, Lucy ; Forrest, Mark ; Graham, Margaret ; Guerrero, Karen ; Hemming, Christine ; Khunda, Aethele ; Mason, Helen ; McClurg, Doreen ; Norrie, John ; Karachalia Sandri, Anastasia ; Thakar, Ranee ; Bugge, Carol. / 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. In: Trials. 2020 ; Vol. 21.

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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 = "prolapse, pessary, self-management, quality of life, economic evaluation, randomised controlled trial (RCT)",

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",

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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

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

In: Trials, Vol. 21, 837, 08.10.2020.

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

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 - prolapse

KW - pessary

KW - self-management

KW - quality of life

KW - economic evaluation

KW - randomised controlled trial (RCT)

U2 - 10.1186/s13063-020-04738-9

DO - 10.1186/s13063-020-04738-9

M3 - Article

C2 - 33032644

VL - 21

JO - Trials

JF - Trials

SN - 1745-6215

M1 - 837

ER -