Whether 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…
ID
Bron
Verkorte titel
Aandoening
English:
Pelvic Organ Prolapse
Pessary
Prolapse surgery
Dutch:
Prolaps
Verzakking
Pessarium
Ring
Prolapschirurgie
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome will be disease specific quality of life, which will be evaluated by using the urogenital distress inventory (UDI).
Achtergrond van het onderzoek
ROK 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.
Doel van het onderzoek
Whether 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.
Onderzoeksopzet
1. 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.
Onderzoeksproduct en/of interventie
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.
Publiek
Postbus 7777
A.L.W.M. Coolen
Veldhoven 5500 MB
The Netherlands
a.coolen@mmc.nl
Wetenschappelijk
Postbus 7777
A.L.W.M. Coolen
Veldhoven 5500 MB
The Netherlands
a.coolen@mmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. POP-Q stage grade 2-4 (POP-Q according to ICS);
2. Eligible for pessary treatment and prolapse surgery.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Isolated rectocele;
2. Previous prolapse treatment;
3. Previous treatment against urine incontinence.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL2719 |
NTR-old | NTR2856 |
Ander register | MEC Maxima Medical Care : 0826 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |