The objective of the CUPIDO-3-trial is to determine which test is best in predicting postoperative (in)continence. Furthermore we want to study the reproducibility of a standardized barrier test.
ID
Source
Brief title
Condition
- Uterine, pelvic and broad ligament disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
absence of urinary (stress) incontinence and subsequent treatment for urinary
(stress) incontinence at 6 and 12 months
Secondary outcome
Urinary distress at 6 and 12 months measured with validated Dutch UDI
questionnaire
Background summary
Continent women have a 11-20% risk to develop stress urinary incontinence after
prolapse repair. This risk is thought to be highest in women with pre-operative
masked or occult stress incontinence. Unfortunately, there is no general
accepted definition of this entity and there are many methods to show occult
stress incontinence. Most methods are so-called barrier tests. This is a cough
test with reduction of the prolapse. A positive test suggests that stress
incontinence is masked by an urethral obstruction caused by the genital
prolapse. Another definition of occult stress incontinence is a reduced
urethral transmission ratio during urodynamics. The prevalence of occult stress
incontinence varies widely from 36-80%. Probably, because of the great variety
in tests. It is unknown which test to demonstrate occult stress incontinence
performs best in predicting postoperative stress incontinence. Also, the
predictive value of these tests is unclear. Based on the present literature
about occult stress incontinence, we believe that barrier tests have a low
positive predictive value, but that some tests might have a high negative
predictive value.
Study objective
The objective of the CUPIDO-3-trial is to determine which test is best in
predicting postoperative (in)continence. Furthermore we want to study the
reproducibility of a standardized barrier test.
Study design
Multi-centre diagnostic trial.
Study burden and risks
Before first visit: UDI questionnaire
First visit: normal barriertest, insertion of pessary and coughtest with pessary
Before second visit: short questionnaire
Second visit (extra): coughtest with pessary, removal of pessary, normal
barriertest
Operation
Standard postop visit at 6 weeks with coughtest
UDI questionnaire at 6 and 12 months
Extra burden: one extra visit with barriertest, at least 7 days pessary,
questionnaires
Risk assesment: low
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Women of 18 year and older planned for vaginal repair of genital prolaps
Exclusion criteria
Mental handicap or unable to to provide informed consent or to complete testing or data collection.
Pregnancy by self-report or positive pregnancy test, or self-reported intention to become pregnant.
12 months or less postpartum (defined as delivery or other termination after 20 wk).
Prior surgery for urinary incontinence (eg TVT or Burch).
Recent (<6 months) pelvic surgery (eg. vaginal hysterectomy).
Prior surgery to bladder or urethra (eg. augmentation cystoplasty or artificial sphincter) or known diverticulum of bladder or urethra.
Systemic disease known to affect bladder function (ie. Parkinson*s disease, multiple sclerosis, spina bifida, spinal cord injury or trauma).
Current cancer chemotherapy or radiotherapy.
Participation in another treatment intervention trial that might influence trial results.
Urinary incontinence as defined in the protocol.
Chronic bladder retention as defined in the protocol.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL17622.018.07 |