Trials (Oct 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

  • 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
https://doi.org/10.1186/s13063-020-04738-9
Journal volume & issue
Vol. 21, no. 1
pp. 1 – 13

Abstract

Read online

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