To assess whether cranberry capsules given peri-operatively reduce the risk of clinical overt UTI after elective pelvic floor surgery with indwelling catheter postoperatively, compared with placebo.
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
Incidence of clinical diagnosis of UTI within 6 weeks after surgery. There is
clinical diagnosis of UTI when the medical doctor (blinded for investigation
arm) diagnoses and treats a UTI.
Secondary outcome
Type of bacteria growing in the urine culture. An urine culture will be
performed in case of clinical diagnosis or suspicion of UTI.
Background summary
One of the most common complications after pelvic floor surgery is an urinary
tract infection (UTI), with an estimated risk of 10-64%. Many trials have been
performed to reduce this rate. Antibiotics as prophylaxis may reduce the
prevalence of UTI*s by 50%, but microbial resistance against antibiotics may be
a large disadvantage. Therefore it is desirable to look for other prophylactic
options. Recent research found a 50% reduction in rate for UTI with the use of
cranberry capsules after elective gynaecology surgery. This suggests that
cranberry capsules may serve as a good prophylaxis for UTI's peri-operatively.
Study objective
To assess whether cranberry capsules given peri-operatively reduce the risk of
clinical overt UTI after elective pelvic floor surgery with indwelling catheter
postoperatively, compared with placebo.
Study design
A single centre randomised controlled, double blind, placebo controlled trial.
Intervention
Cranberry capsules given for 6 weeks post-operatively compared with placebo
capsules.
Study burden and risks
Cranberries are safely used worldwide as a possible prophylaxis for UTI*s and
are available in many forms. Intake of the capsules is an easy intervention
with low impact on daily life and might have significant beneficial effects on
the recovery after pelvic floor surgery. No additional interventions will be
performed in this trial.
Risks for the participants are almost negligible. Based on international
literature there is only a minimal chance for a serious adverse event caused by
intake of cranberry capsules.
Montessoriweg 1
Rotterdam 3083AN
NL
Montessoriweg 1
Rotterdam 3083AN
NL
Listed location countries
Age
Inclusion criteria
Women undergoing pelvic floor surgery
Exclusion criteria
Allergy for cranberries is an exclusion criterium. Women with a history of nephrolithiasis, congenital urogenital anomaly or neurogenic bladder will be excluded.
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 | NL57693.101.16 |