To test the value of preoperatively performed urodynamics with regard to outcome of surgery for stress urinary incontinence (SUI) and to examine whether not performing urodynamics preoperatively is more cost effective than performing urodynamics…
ID
Source
Brief title
Condition
- Urinary tract signs and symptoms
- Uterine, pelvic and broad ligament disorders
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome: Non inferiority of the improvement of the UDI one year after
treatment in the non urodynamics group.
Secondary outcome
Secondary outcomes: Cure of incontinence as measured with pad test and voiding
diary. Complications of surgery for stress incontinence in particular
re-operation and overactive bladder symptoms of quality of life as measured by
validated questionnaires.
Background summary
The urodynamic investigations that differentiate between several types of
stress urinary incontinence and thus tailor the specific type of operation,
lack validation and predictive value in individual cases. It is therefore
questionable whether it can predict the therapeutic effect as well as the risk
of complications like de novo urgency and urinary retention. Moreover, since
the introduction of easy to administer midurethral polypropylene slings, every
type of SUI is treated in the same way and therefore probably no urodynamic
investigation for that purpose needs to be done.
Study objective
To test the value of preoperatively performed urodynamics with regard to
outcome of surgery for stress urinary incontinence (SUI) and to examine whether
not performing urodynamics preoperatively is more cost effective than
performing urodynamics preoperatively using the non-inferiority assumption.
Study design
Study design:
Multicentre, randomised controlled multidisciplinary trial.
Intervention
Intervention: stress urinary incontinence therapy based on history, clinical
examination, pad test and 48h voiding diary versus therapy based on the same
parameters AND urodynamic findings
Study burden and risks
Burden: Five outpatient visits (of which one contains the ususal prostoperative
visit), with 48h-Bladder(voiding and incontinence) diary, pad test, urinalysis,
ultrasound to measure residual urine and completion of questionnaire.
Risk: possibly increased risk of complications like de novo urgency and urinary
retention in non-urodynamics group.
Postbus 9101
6500 HB Nijmegen
NL
Postbus 9101
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
All women, not previously operated for stress incontinence, seeking help for urinary stress incontinence where conservative therapy in particular physiotherapy has failed and are opting and candidates for surgical therapy can participate in the study. Incontinence must have been demonstrated on physical examination and/or micturition diary. Patients can be included by gynaecologists or urologists who are cooperating in the study.
Exclusion criteria
Women with a history of urge incontinence.
Women with previous urinary incontinence surgery.
Women incapable to read and speak Dutch.
Women not giving informed consent.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL14625.091.06 |
| OMON | NL-OMON24532 |