Primary objective: Does removal of an IUC late at night on the day of vaginal prolapse surgery lead to a decrease in clinical UTIs in the first six weeks after surgery compared to removal on the morning of the first day after surgery?Secondary…
ID
Source
Brief title
Condition
- Urinary tract signs and symptoms
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Amount of clinically suspected UTIs within 6 weeks after surgery.
Secondary outcome
- Occurrence of a PVR >150cc after removal of the IUC in two consecutive
measurements after two different attempts for micturition.
- Occurrence of asymptomatic bacteriuria developing into a clinically suspected
UTI within 6 weeks after surgery.
- Patient satisfaction at discharge from the hospital.
- Total duration of admittance to the hospital
- Total duration of catheterisation
Background summary
After vaginal prolapse surgery an indwelling urinary catheter (IUC) is placed.
Often it is removed on the first postoperative day. After removal of the IUC
10-40% of patients is unable to fully empty the bladder during micturition.
Among contributing factors are fear and preoccupation with micturition. In
these cases temporary subsequent catheterisation is needed. Research shows that
with longer duration of initial catheterisation chances of developing an
urinary tract infection (UTI) increase, while chances of incomplete bladder
emptying decrease. To reduce the influence of fear and preoccupation with
micturition it can be considered removing the IUC late at night instead of
early in the morning.
Study objective
Primary objective: Does removal of an IUC late at night on the day of vaginal
prolapse surgery lead to a decrease in clinical UTIs in the first six weeks
after surgery compared to removal on the morning of the first day after surgery?
Secondary objective: Is the chance on early dysfunctional voiding comparable
when an IUC is removed late at night on the day of vaginal prolapse surgery
compared to removal on the morning of the first day after surgery?
Study design
Multicentre randomised controlled trial with nested cohort study.
Intervention
In the study group IUC is removed at night on the day of the surgery. In the
control group the IUC is removed on the morning of the day after surgery.
Study burden and risks
N/A
Van Swietenplein 1
Groningen 9728 NT
NL
Van Swietenplein 1
Groningen 9728 NT
NL
Listed location countries
Age
Inclusion criteria
Patients aged 18 years or older undergoing surgery for vaginal prolapse.
Exclusion criteria
1. Existing neurological disorder which is likely to influence bladder function (e.g. dementia, MS, spinal disc herniation)
2. Existing anxiety disorder
3. Insufficient comprehension of the Dutch language
4. Concurrent surgery for incontinence (e.g. midurethral sling, burch colposuspension)
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 | NL64233.099.18 |