Status:
COMPLETED
L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract to Prevent Postoperative Urinary Tract Infection.
Lead Sponsor:
IRCCS San Raffaele
Conditions:
Urinary Tract Infection
Pelvic Organ Prolapse
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This study will include women who will undergo pelvic reconstructive surgery and/or anti-incontinence sling procedures. Patients will be randomized to the combination of L-methionine, Hibiscus Sabdari...
Eligibility Criteria
Inclusion
- postoperative transurethral catheterization after surgery for pelvic organ prolapse and/or urinary incontinence
- patients aged ≥ 18 years
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT02216253
Start Date
October 1 2014
Last Update
August 26 2015
Active Locations (1)
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1
IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University
Milan, Lombardy, Italy, 20100