For this study our hypothesis was that there is no difference between outcome of surgery and individually tailored therapy in women with a discrepancy between urodynamic findings and findings from other investigations, such as history and clinical…
ID
Bron
Verkorte titel
Aandoening
urodynamics
stress incontinence
urodynamisch onderzoek
stressincontinentie
Ondersteuning
Projectnumber 945-07-203.
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome of this study is clinical improvement of incontinence as measured with the validated Dutch version of the UDI.
Achtergrond van het onderzoek
Background:
Stress urinary incontinence (SUI) is a common problem. In the Netherlands, yearly 64.000 new patients, of whom 96% are women, consult their general practitioner because of urinary incontinence. Approximately 7500 urodynamic evaluations and approximately 5000 operations for SUI are performed every year. In all major national and international guidelines from both gynaecological and urological scientific societies, it is advised to perform urodynamics prior to invasive treatment for SUI, but neither its effectiveness nor its cost-effectiveness has been assessed in a randomized setting.
The Value of Urodynamics prior to Stress Incontinence Surgery (VUSIS) study evaluates the positive and negative effects with regard to outcome, as well as the costs of urodynamics, in women with symptoms of SUI in whom surgical treatment is considered.
Study design:
A multicentre diagnostic cohort study will be performed with an embedded randomized controlled trial among women presenting with symptoms of (predominant) SUI.
Urinary incontinence has to be demonstrated on clinical examination and/or voiding diary. Physiotherapy must have failed and surgical treatment needs to be under consideration.
Patients will be excluded in case of previous incontinence surgery, in case of pelvic organ prolapse more than 1 centimeter beyond the hymen and/or in case of residual bladder volume of more than 150 milliliter on ultrasound or catheterisation.
Patients with discordant findings between the diagnosis based on urodynamic investigation and the diagnosis based on their history, clinical examination and/or micturition diary will be randomized to operative therapy or individually tailored therapy based on all available information.
Patients will be followed for two years after treatment by their attending urologist or gynaecologist, in combination with the completion of questionnaires.
Six hundred female patients will be recruited for registration from approximately twenty-seven hospitals in the Netherlands. We aspect that one hundred and two women with discordant findings will be randomized.
The primary outcome of this study is clinical improvement of incontinence as measured with the validated Dutch version of the Urinary Distress Inventory (UDI). Secondary outcomes of this study include costs, cure of incontinence as measured by voiding diary parameters, complications related to the intervention, re-interventions, and generic quality of life changes.
Doel van het onderzoek
For this study our hypothesis was that there is no difference between outcome of surgery and individually tailored therapy in women with a discrepancy between urodynamic findings and findings from other investigations, such as history and clinical examination. In case of confirmation of this hypothesis, urodynamic investigation in women with predominant SUI could be safely omitted.
Onderzoeksopzet
T=0, follow-up at 6 weeks, 6, 12 en 24 months.
Onderzoeksproduct en/of interventie
Midurethral sling procedure versus individual treatment.
Publiek
791, Dept of Obstetrics and Gynecology
PO Box 9101
Sanne Leijsen van
Radboud University Nijmegen Medical Centre
791, Dept of Obstetrics and Gynecology
Nijmegen 6500 HB
The Netherlands
+31 641520114
sannevanleijsen@hotmail.com
Wetenschappelijk
791, Dept of Obstetrics and Gynecology
PO Box 9101
Sanne Leijsen van
Radboud University Nijmegen Medical Centre
791, Dept of Obstetrics and Gynecology
Nijmegen 6500 HB
The Netherlands
+31 641520114
sannevanleijsen@hotmail.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Symptoms of stress urinary incontinence and/or mixed urinary incontinence, predominantly stress incontinence;
2. Signs of stress urinary incontinence on physical examination or voiding diary;
3. Patient is a candidate for surgical treatment (as based on history and physical examination);
4. Patient has attended at least 3 months of pelvic floor exercises;
5. Patient is capable to fill out bladder diaries, pad tests and questionnaires and understands the Dutch written and spoken language.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Previous incontinence surgery;
2. Mixed urinary incontinence, urge component is predominant;
3. Pelvic organ prolapse > 1cm beyond the hymen on Valsalva in supine position;
4. Post void urinary residual > 150ml on ultrasound or catheterisation;
5. Additional pelvic surgery (prolapse and/or hysterectomy);
6. Patient is or wants to become pregnant;
7. Prior pelvic radiotherapy.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL1761 |
NTR-old | NTR1871 |
CCMO | NL14625.091.06 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |
OMON | NL-OMON30485 |