L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract to Prevent Postoperative Urinary Tract Infection.

IRCCS San Raffaele150 enrolled

Overview

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 Sabdariffa and Boswellia Leaf Extract in tablet or placebo twice a day during the seven days before and after surgery (total of 14 days). In this randomized, double-blind study, the investigators will assess treatment of clinically suspected or culture-proven urinary tract infections within 3 weeks of surgery (primary outcome), and risk factors for treatment for postoperative urinary tract infections (secondary outcomes) between the two study groups.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

150

Conditions

Urinary Tract Infection Pelvic Organ Prolapse Urinary Incontinence

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Treatment for urinary tract infection after surgery.

To assess any treatment received for clinically suspected or culture-proven urinary tract infection within 3 weeks of surgery.

Time frame: 3 weeks after surgery.