Polyvinyl chloride ring pessary versus silicon irregular hexagon pessary for pelvic organ prolapse: a randomised trial comparing treatment success
Not Applicable
Completed
- Conditions
- Pelvic organ prolapse (POP)Reproductive Health and Childbirth - Other reproductive health and childbirth disorders
- Registration Number
- ACTRN12618000416291
- Lead Sponsor
- The Royal Women's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 104
Inclusion Criteria
At least 18 years old with symptomatic POP
Able to speak and read English
Not previously used a vaginal pessary for POP
At least stage II POP from any single compartment or a multi-compartment POP
Willing to use ring pessary
Willing and able to complete quality of life (QoL) questionnaires and attend follow-up visits
Exclusion Criteria
Refusal to participate in the study
Unable to speak or read English
Women less than 18 years old
Previous vaginal pessary use
Prior prolapse surgery
Contraindicated to topical oestrogen therapy e.g. previous or current history of breast cancer
Unwilling to use a vaginal pessary
Unwilling and unable to complete QoL questionnaires and attend follow-up visits
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The measure of primary outcome will be treatment success for the two pessaries. Treatment success will be defined as retention of the pessary at 6 months and 12 months post randomisation[Outcome will be assessed at 6 and 12 months (primary timepoint) post randomisation]
- Secondary Outcome Measures
Name Time Method Proportion of subjects able to perform self-care during pessary use, This will be self reported by subjects whether or not they are able to perform self care.[at 6 months and 12 months post randomisation];Subjects’ satisfaction with pessary treatment based on quality of life questionnaires:<br>(i) Pelvic Floor Distress Inventory Questionnaires (PFDI-20) to assess the severity of pelvic organ prolapse symptoms and impact on bowel and bladder function; <br>(ii) Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaires (PISQ-12) to measure sexual function in women with pelvic floor disorders; and <br>(iii) Euro Qol Health Questionnaires (EQ-5D) to assess current health status [At 6 months and 12 months post randomisation];Adverse events such as vaginal discharge, bleeding, offensive odour and vaginal ulceration will be assessed using Pelvic Organ Pessary Symptoms Questionnaires (POP-SQ)[at 6 months and 12 months post randomisation]