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

August 24, 2015 updated by: Umberto Leone Roberti Maggiore, IRCCS San Raffaele

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lombardy
      • Milan, Lombardy, Italy, 20100
        • IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
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
Placebo Comparator: Placebo
Placebo tablet twice a day 7 days before and after surgery
Other: Placebo
Placebo tablet twice a day 7 days before and after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment for urinary tract infection after surgery.
Time Frame: 3 weeks 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Investigators

  • Principal Investigator: Umberto Leone Roberti Maggiore, MD, IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University
  • Study Director: Stefano Salvatore, MD, IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

August 9, 2014

First Submitted That Met QC Criteria

August 11, 2014

First Posted (Estimate)

August 13, 2014

Study Record Updates

Last Update Posted (Estimate)

August 26, 2015

Last Update Submitted That Met QC Criteria

August 24, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UTI 2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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