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Pessary or prolapse surgery for symptomatic pelvic organ prolapse


- candidate number20991
- NTR NumberNTR4883
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-nov-2014
- Secondary IDsNL05717.041.14 METC 14/533
- Public TitlePessary or prolapse surgery for symptomatic pelvic organ prolapse
- Scientific TitlePessary or prolapse surgery for symptomatic pelvic organ prolapse
- ACRONYMPEOPLE
- hypothesisThe strategy of pessary as initial therapy is as effective as direct surgery for moderate to severe POP, but it is associated with lower costs.
- Healt Condition(s) or Problem(s) studiedProlapse, Prolapse surgery, Pessary, Pelvic organ prolaps
- Inclusion criteria1. Women with a prolapse stage 2 or more.
2. Women with moderate to severe POP symptoms. Moderate to severe POP symptoms is defined as a prolapse domain score > 33 on the validated Dutch version of the Pelvic Floor Distress Inventory (PFDI-20).
3. Women who have had a successful pessary fitting procedure: for the RCT.
4. Written informed consent.
- Exclusion criteria1. Prior urogynaecological (prolapse or incontinence) surgery
2. Probability of future childbearing
3. Insufficient knowledge of the Dutch language
4. Co-morbidity causing increased surgical risks at the discretion of the surgeon
5. Major psychiatric illness
6. Prior pessary use
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blinding[default]
- control[default]
- group[default]
- Type[default]
- Studytypeintervention
- planned startdate 23-mrt-2015
- planned closingdate1-dec-2018
- Target number of participants436
- InterventionsPessary therapy or vaginal POP surgery.
- Primary outcomeGlobal impression of improvement of POP symptoms at 24 months measured with PGI-I.
- Secondary outcome• Changes in symptom bother and disease-specific quality of life at 12 and 24 months follow-up
• Changes of sexual function at 12 and 24 months follow-up
• Changes in general quality of life at 3, 6, 12 and 24 months of follow up
• Adverse events/complications related to both treatment strategies during the study period
• Development of prediction model to identify factors for failing of pessary and surgery.
• Costs-effectiveness analyses
- Timepoints3, 6, 12 and 24 months
- Trial web sitehttp://www.studies-obsgyn.nl/PEOPLE/
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD M.K. Waarsenburg, van de
- CONTACT for SCIENTIFIC QUERIESDr. C.H. Vaart, van der
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryModerate to severe pelvic organ prolapse symptoms can be treated with pessary or surgery. Both treatments appear to be effective, but have not been compared directly.
- Main changes (audit trail)20-apr-2015:
Intervention:
Old: “Pessary therapy or vaginal POP surgery”
New: “Pessary or POP surgery”

Timeline:
Old:“3, 6, 12 and 24 months”
New: “Baseline, 3, 6, 12 and 24 months”
- RECORD18-nov-2014 - 20-apr-2015


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