|- candidate number||25013|
|- NTR Number||NTR5995|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-aug-2016|
|- Secondary IDs||CCMO register NL57693.101.16|
|- Public Title||Cranberries after pelvic floor surgery for urinary tract infection prophylaxis|
|- Scientific Title||Cranberries after pelvic floor surgery for urinary tract infection prophylaxis|
|- ACRONYM||CUTIP trial|
|- hypothesis||Cranberry capsules given peri-operatively reduce the risk of clinical overt urinary tract infection after elective pelvic floor surgery with indwelling catheter postoperatively compared with placebo|
|- Healt Condition(s) or Problem(s) studied||Urinary tract infections, Cranberry, Pelvic floor muscles|
|- Inclusion criteria||Women planned for pelvic floor surgery, older than 18 years old, not pregnant and able to understand the Dutch language. |
|- Exclusion criteria||Women with a history of nephrolithiasis, congenital urogenital anomaly or neurogenic bladder will be excluded. Women operated for removal of Mesh implants will also be excluded.
Women using antibiotics at the moment of surgery for other medical reasons or women with chronic indwelling urinary catheter will also be excluded.|
Furthermore, an allergy for cranberries is an exclusion criterion.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2016|
|- planned closingdate||31-dec-2017|
|- Target number of participants||200|
|- Interventions||Cranberry capsules given for 6 weeks peri-operatively compared with placebo capsules.|
|- Primary outcome||Incidence of clinical diagnosis of urinary tract infection within 6 weeks after surgery. There is clinical diagnosis of urinary tract infection when the medical doctor (blinded for investigation arm) diagnoses and treats a urinary tract infection.|
|- Secondary outcome||Confirmation of the clinical diagnosis of urinary tract infection by urine culture. The type of microorganisms growing in culture of urine samples will be noted. |
|- Timepoints||Diagnosis of urinary tract infection within six weeks after surgery.
Primary outcome is diagnosis and treatment by the medical docter based on symptoms and urine sediment.
Secondary outcome is confirmation of the diagnosis by urine culture.|
|- Trial web site||not available|
|- CONTACT FOR PUBLIC QUERIES||MSc E.S. Mooren|
|- CONTACT for SCIENTIFIC QUERIES||MSc E.S. Mooren|
|- Sponsor/Initiator ||Ikazia Hospital|
(Source(s) of Monetary or Material Support)
|- Brief summary||Rationale: 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 UTIís by 50%, but microbial resistance against antibiotics may be a large disadvantage. Therefor 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 UTIís peri-operatively.
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.
Study population: All women planned for elective pelvic floor surgery.
Intervention: Cranberry capsules given for 6 weeks peri-operatively compared with placebo capsules.
Main study endpoints: 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.
Analysis and sample size: The analysis will be performed by intention to treat. The sample size calculated is 100 women in each arm, as we expect the rate of UTI to drop from 40% to 20% with Cranberry prophylaxis, based on current incidence and results from other trials. In this sample size calculation we expect a 10% drop-out rate during the trial.
|- Main changes (audit trail)|
|- RECORD||11-aug-2016 - 29-sep-2016|