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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 September 2015 |
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Main ID: |
NCT02216253 |
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Date of registration:
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09/08/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract to Prevent Postoperative Urinary Tract Infection.
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Scientific title:
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L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract to Prevent Postoperative Urinary Tract Infection: a Double-blind Randomized Controlled Trial. |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02216253 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Italy
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Contacts
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Name:
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Stefano Salvatore, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University |
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Name:
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Umberto Leone Roberti Maggiore, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- postoperative transurethral catheterization after surgery for pelvic organ prolapse
and/or urinary incontinence
- patients aged = 18 years
Exclusion Criteria:
- acute urinary tract infection at the moment of inclusion in the study
- antibiotic treatment prescribed for any other cause than urinary tract infection
- pregnancy
- known allergy to one of the elements of the active compound
- surgery for mesh excision
- surgery for urethral diverticulum
- surgery for fistula repair
- surgery for sacral neuromodulation
- any condition precluding the acquisition of written consent
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Urinary Incontinence
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Urinary Tract Infection
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Pelvic Organ Prolapse
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Intervention(s)
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Drug: L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract
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Other: Placebo
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Primary Outcome(s)
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Treatment for urinary tract infection after surgery.
[Time Frame: 3 weeks after surgery.]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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