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

被引：9

作者：

Hagen, Suzanne ^{[1
]}

Kearney, Rohna ^{[2
,3
]}

Goodman, Kirsteen ^{[1
]}

Melone, Lynn ^{[1
]}

Elders, Andrew ^{[1
]}

Manoukian, Sarkis ^{[4
]}

Agur, Wael ^{[5
,6
]}

Best, Catherine ^{[7
]}

Breeman, Suzanne ^{[8
]}

Dembinsky, Melanie ^{[9
]}

Dwyer, Lucy ^{[2
,3
]}

Forrest, Mark ^{[8
]}

Graham, Margaret ^{[10
]}

Guerrero, Karen ^{[11
]}

Hemming, Christine ^{[12
,13
]}

Khunda, Aethele ^{[14
]}

Mason, Helen ^{[4
]}

McClurg, Doreen ^{[1
]}

Norrie, John ^{[15
]}

Karachalia-Sandri, Anastasia ^{[1
]}

Thakar, Ranee ^{[16
]}

Bugge, Carol ^{[9
]}

机构：

[1] Glasgow Caledonian Univ, Res Unit, Glasgow, Lanark, Scotland

[2] Manchester Univ Hosp NHS Fdn Trust, Manchester Acad Hlth Sci Ctr, Warrell Unit, St Marys Hosp, Manchester, Lancs, England

[3] Univ Manchester, Univ Inst Human Dev, Fac Med Human Sci, Manchester, Lancs, England

[4] Glasgow Caledonian Univ, Yunus Ctr Social Business & Hlth, Glasgow, Lanark, Scotland

[5] Crosshouse Hosp, NHS Ayrshire & Arran, Kilmarnock, Scotland

[6] Univ Glasgow, Sch Med Dent & Nursing, Glasgow, Lanark, Scotland

[7] Univ Stirling Innovat Pk, NMAHP Res Unit, Unit 13 Scion House, Stirling, Scotland

[8] Univ Aberdeen, Hlth Serv Res Unit HSRU, Aberdeen, Scotland

[9] Univ Stirling, Hlth Sci & Sport, Stirling, Scotland

[10] Patient & Publ Involvement PPI Representat, Dunlop, England

[11] NHS Greater Glasgow & Clyde, Dept Urogynaecol, Glasgow, Lanark, Scotland

[12] Grampian Univ Hosp NHS Trust, Aberdeen Matern Hosp, Aberdeen, Scotland

[13] Grampian Univ Hosp NHS Trust, Aberdeen Royal Infirm, Aberdeen, Scotland

[14] South Tees Hosp NHS Fdn Trust, James Cook Univ Hosp, Middlesbrough, Cleveland, England

[15] Univ Edinburgh, Coll Med & Vet Med, Usher Inst Populat Hlth Sci & Informat, Edinburgh, Midlothian, Scotland

[16] Croydon Hlth Serv NHS Trust, Croydon Univ Hosp, Croydon, England

来源：

TRIALS | 2020年 / 21卷 / 01期

关键词：

Prolapse; Pessary; Self-management; Quality of life; Economic evaluation; Randomised controlled trial (RCT); GLOBAL IMPRESSION; WOMEN; QUESTIONNAIRES; VALIDATION; HISTORY; OLDER;

D O I：

10.1186/s13063-020-04738-9

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

BackgroundPelvic 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.MethodsThis 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 18months' post-randomisation. Several secondary outcomes will also be assessed using participant-completed questionnaires. Questionnaires will be administered at baseline, 6, 12 and 18months' 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.DiscussionThe 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 registrationISRCTN Registry ISRCTN62510577. Registered on June 10, 2017.

引用

页数：13

共 34 条

[31] Effect of pelvic floor muscle training compared with watchful waiting in older women with symptomatic mild pelvic organ prolapse: randomised controlled trial in primary care [J].