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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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 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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS San Raffaele

Criteria

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