No registrations found.
ID
Source
Brief title
Health condition
-Symptomatic pelvic organ prolapse.
-Verzakking van bekkenorganen met klachten.
-Pessary, prlapse surgery.
-Pessarium, ring. Verzakkingsoperatie, prolapsoperatie.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Global 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
Background summary
Moderate 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.
Study objective
The strategy of pessary as initial therapy is as effective as direct surgery for moderate to severe POP, but it is associated with lower costs.
Study design
Baseline, 3, 6, 12 and 24 months
Intervention
Pessary or POP surgery
M.K. Waarsenburg, van de
University Medical Centre Utrecht, room F05.1.26
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31887550927
M.K.vandeWaarsenburg@umcutrecht.nl
M.K. Waarsenburg, van de
University Medical Centre Utrecht, room F05.1.26
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31887550927
M.K.vandeWaarsenburg@umcutrecht.nl
Inclusion criteria
1. 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 criteria
1. 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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4756 |
| NTR-old | NTR4883 |
| CCMO | NL05717.041.14 |