search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Cranberries after pelvic floor surgery for urinary tract infection prophylaxis


- candidate number25013
- NTR NumberNTR5995
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-aug-2016
- Secondary IDsCCMO register NL57693.101.16
- Public TitleCranberries after pelvic floor surgery for urinary tract infection prophylaxis
- Scientific TitleCranberries after pelvic floor surgery for urinary tract infection prophylaxis
- ACRONYMCUTIP trial
- hypothesisCranberry 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) studiedUrinary tract infections, Cranberry, Pelvic floor muscles
- Inclusion criteriaWomen planned for pelvic floor surgery, older than 18 years old, not pregnant and able to understand the Dutch language.
- Exclusion criteriaWomen 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2016
- planned closingdate31-dec-2017
- Target number of participants200
- InterventionsCranberry capsules given for 6 weeks peri-operatively compared with placebo capsules.
- Primary outcomeIncidence 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 outcomeConfirmation of the clinical diagnosis of urinary tract infection by urine culture. The type of microorganisms growing in culture of urine samples will be noted.
- TimepointsDiagnosis 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 sitenot available
- statusplanned
- CONTACT FOR PUBLIC QUERIESMSc E.S. Mooren
- CONTACT for SCIENTIFIC QUERIESMSc E.S. Mooren
- Sponsor/Initiator Ikazia Hospital
- Funding
(Source(s) of Monetary or Material Support)
Ikazia Hospital
- Publications
- Brief summaryRationale: 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)
- RECORD11-aug-2016 - 29-sep-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl