Skip to main content
MedPathMedPath Home
Clinical Trials/ISRCTN62510577
ISRCTN62510577
Completed
N/A

A multi-centre randomised controlled trial , with process evaluation, to test the clinical and cost-effectiveness of self-management of vaginal pessaries to treat pelvic organ prolapse, compared to standard care to improve women's quality of life

Glasgow Caledonian University0 sites340 target enrollmentOctober 6, 2017
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
Glasgow Caledonian University
Enrollment
340
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33032651/ process evaluation protocol (added 14/10/2020) 2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33032644/ protocol (added 14/10/2020) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/36064727/ Theoretical and practical development of the TOPSY self-management intervention for women who use a vaginal pessary for pelvic organ prolapse (added 06/09/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/38078194/ (added 19/12/2023) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38767959/ Clinical and cost-effectiveness (added 22/05/2024)

Registry
who.int
Start Date
October 6, 2017
End Date
January 31, 2024
Last Updated
last year
Study Type
Interventional
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Women with pelvic organ prolapse of any type or stage
  • •2\. Aged \=18 years
  • •3\. Women treated with a vaginal pessary
  • •4\. Pessary retained for 2 weeks or more

Exclusion Criteria

  • •1\. Women with a shelf or Gellhorn pessary as these are difficult for women to remove and replace themselves
  • •2\. Women lacking in manual dexterity, e.g. those with arthritis, as women would not be able to remove and replace her own pessary
  • •3\. Women judged by the treating clinician to have a cognitive deficit such that she would be unable to give informed consent or understand self\-management instruction
  • •4\. Pregnant women

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, Not Recruiting
N/A
Scaphoid Waist Internal Fixation for Fractures Trial: A trial evaluating cast versus surgical fixation for fractures of the scaphoid waist in adultsMusculoskeletal trauma of the hand and wristMusculoskeletal Diseases
ISRCTN67901257niversity Hospitals of Leicester NHS Trust (UK)439
Completed
N/A
Health professional Administered Brief Insomnia Therapy (HABIT) trialInsomniaMental and Behavioural DisordersDisorders of initiating and maintaining sleep [insomnias]
ISRCTN42499563niversity of Oxford642
Completed
N/A
Systemic Autism-related Family Enabling (SAFE) studySpecialty: Mental health, Primary sub-specialty: Developmental disorders - AutismUKCRC code/ Disease: Mental Health/ Disorders of psychological developmentMental and Behavioural DisordersAutism
ISRCTN83964946Plymouth Hospitals NHS Trust36
Completed
Phase 3
Vaccine Response On/off Methotrexate (VROOM): does temporarily suspending methotrexate treatment for two weeks enhance COVID-19 vaccine response?
ISRCTN11442263CTU0373383
Active, Not Recruiting
N/A
Autologous stem cell transplantation versus alemtuzumab, ocrelizumab, ofatumumab or cladribine in relapsing-remitting multiple sclerosisRelapsing-remitting multiple sclerosisNervous System DiseasesMultiple sclerosis
ISRCTN88667898Sheffield Teaching Hospitals NHS Foundation Trust198