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

Urinary Incontinence Clinical Trial

Official title:

L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract to Prevent Postoperative Urinary Tract Infection: a Double-blind Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02216253
• Other study ID #: UTI 2014
• Status: Completed
• Phase: N/A
• First received: August 9, 2014
• Last updated: August 24, 2015
• Start date: October 2014

Study information

• Verified date: August 2015
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Pelvic Organ Prolapse
• Prolapse
• Urinary Incontinence
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Drug:
• L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract
L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract tablet twice a day 7 days before and after surgery

Other:
• Placebo
Placebo tablet twice a day 7 days before and after surgery

Locations

Country	Name	City	State
Italy	IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University	Milan	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 weeks after surgery.	No