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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR2856 |
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Date of registration:
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17/04/2011 |
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Primary sponsor: |
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Public title:
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Primary treatment of vaginal prolapse: Pessary use versus prolapse surgery.
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Scientific title:
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Primary treatment of vaginal prolapse: Pessary use versus prolapse surgery. - ROK |
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Date of first enrolment:
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1/1/2010 |
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Target sample size:
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80 |
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Recruitment status: |
recruiting |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2856 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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A.L.W.M.
Coolen |
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Address:
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Polikliniek gynaecologie, tav A.Coolen
Postbus 7777
5500 MB
Veldhoven
The Netherlands |
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Telephone:
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Email:
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a.coolen@mmc.nl |
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Affiliation:
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Name:
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A.L.W.M.
Coolen |
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Address:
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Polikliniek gynaecologie, tav A.Coolen
Postbus 7777
5500 MB
Veldhoven
The Netherlands |
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Telephone:
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Email:
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a.coolen@mmc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. POP-Q stage grade 2-4 (POP-Q according to ICS);
2. Eligible for pessary treatment and prolapse surgery.
Exclusion criteria: 1. Isolated rectocele;
2. Previous prolapse treatment;
3. Previous treatment against urine incontinence.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Pessary, Prolapse, Prolapse surgery
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Intervention(s)
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Pessary:
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.
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Primary Outcome(s)
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The primary outcome will be disease specific quality of life, which will be evaluated by using the urogenital distress inventory (UDI).
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Secondary Outcome(s)
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1. 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.
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Source(s) of Monetary Support
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Maxima Medical Center
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