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.
ID
Bron
Verkorte titel
Aandoening
-Symptomatic pelvic organ prolapse.
-Verzakking van bekkenorganen met klachten.
-Pessary, prlapse surgery.
-Pessarium, ring. Verzakkingsoperatie, prolapsoperatie.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Global impression of improvement of POP symptoms at 24 months measured with PGI-I.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
Baseline, 3, 6, 12 and 24 months
Onderzoeksproduct en/of interventie
Pessary or POP surgery
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4756 |
| NTR-old | NTR4883 |
| CCMO | NL05717.041.14 |