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

Not Applicable

Completed

• Conditions: Urinary Tract Infection; Pelvic Organ Prolapse; Urinary Incontinence
• Interventions: Other: Placebo; Drug: L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract

• Registration Number: NCT02216253
• Lead Sponsor: IRCCS San Raffaele

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-09
• Study First Submitted QC: 2014-08-11
• Study First Posted: 2014-08-13
• Study Start: 2014-10
• Status Verified: 2015-08
• Primary Completion: 2015-08
• Last Update Submitted: 2015-08-24
• Last Update Posted: 2015-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo tablet twice a day 7 days before and after surgery
L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract	L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract	The combination of L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract will be administered in tablet twice a day 7 days before and after surgery

Primary Outcome Measures

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

Trial Locations

Locations (1)

IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University; 🇮🇹 Milan, Lombardy, Italy