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Primary treatment of vaginal prolapse: Pessary use versus prolapse surgery.


- candidate number9340
- NTR NumberNTR2856
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-apr-2011
- Secondary IDs0826 MEC Maxima Medical Care
- Public TitlePrimary treatment of vaginal prolapse: Pessary use versus prolapse surgery.
- Scientific TitlePrimary treatment of vaginal prolapse: Pessary use versus prolapse surgery.
- ACRONYMROK
- hypothesisWhether the use of pessary therapy is successful against vaginal prolapse or not might be predictable. A higher age of the patient at baseline, and succeeding pessary therapy for the period of one month is plausible associated with prolonged pessary use. On the other hand, discomfort of pessary use during the first month could be associated with failure of pessary therapy. Furthermore a certain sexual activity level and a preference for prolapse surgery might predict the failure rate.
- Healt Condition(s) or Problem(s) studiedPessary, Prolapse, Prolapse surgery
- Inclusion criteria1. POP-Q stage grade 2-4 (POP-Q according to ICS);
2. Eligible for pessary treatment and prolapse surgery.
- Exclusion criteria1. Isolated rectocele;
2. Previous prolapse treatment;
3. Previous treatment against urine incontinence.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2010
- planned closingdate1-jan-2013
- Target number of participants80
- InterventionsPessary:
1. Portex;
2. Falk.

Prolapse surgery:
1. Vaginal hysterectomy;
2. Anterior colporrhaphy;
3. Posterriorcolporrhaphy;
4. A combination of above-mentioned surgical treatments;
5. A combination of above-mentioned surgical treatments including MESH material.
- Primary outcomeThe primary outcome will be disease specific quality of life, which will be evaluated by using the urogenital distress inventory (UDI).
- Secondary outcome1. General quality of life and patients satisfaction rate. Both will be evaluated by using a validated questionnaire (werkgroepbekkenbodem, eurqol, SF-36);
2. Successful continuous pessary treatment;
3. Anatomical result. Evaluated through pelvic examination according to the recommendations of the ICS.
- Timepoints1. Pre-treatment: POP-Q and questionnaire;
2. 6 weeks post treatment: Questionnaire;
3. 6 months post treatment: Questionnaire;
4. 1 years post treatment: POP-Q and questionnaire.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES A.L.W.M. Coolen
- CONTACT for SCIENTIFIC QUERIES A.L.W.M. Coolen
- Sponsor/Initiator Máxima Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Maxima Medical Center
- PublicationsN/A
- Brief summaryROK is a randomized controlled trial of pessary use versus prolapse surgery in patients with POP-Q stage 2-4 pelvic organ prolapse who are eligible for both treatments. The primary outcome is disease specific quality of life. Secondary outcomes are general quality of life, satisfaction, anatomical results and successful continuous pessary use.
- Main changes (audit trail)
- RECORD17-apr-2011 - 29-apr-2017


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