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

Primary Purpose

Urinary Tract Infection, Pelvic Organ Prolapse, Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract
Placebo
Sponsored by
IRCCS San Raffaele
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Tract Infection focused on measuring Urinary tract infection, Pelvic organ prolapse, Urinary incontinence, Stress urinary incontinence, Mixed Urinary incontinence, L-methionine, Placebo

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract

Placebo

Arm Description

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

Placebo tablet twice a day 7 days before and after surgery

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 9, 2014
Last Updated
August 24, 2015
Sponsor
IRCCS San Raffaele
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1. Study Identification

Unique Protocol Identification Number
NCT02216253
Brief Title
L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract to Prevent Postoperative Urinary Tract Infection.
Official Title
L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract to Prevent Postoperative Urinary Tract Infection: a Double-blind Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Raffaele

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection, Pelvic Organ Prolapse, Urinary Incontinence
Keywords
Urinary tract infection, Pelvic organ prolapse, Urinary incontinence, Stress urinary incontinence, Mixed Urinary incontinence, L-methionine, Placebo

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet twice a day 7 days before and after surgery
Intervention Type
Drug
Intervention Name(s)
L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract
Intervention Description
L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract tablet twice a day 7 days before and after surgery
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet twice a day 7 days before and after surgery
Primary Outcome Measure Information:
Title
Treatment for urinary tract infection after surgery.
Description
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Umberto Leone Roberti Maggiore, MD
Organizational Affiliation
IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stefano Salvatore, MD
Organizational Affiliation
IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University
Official's Role
Study Director
Facility Information:
Facility Name
IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University
City
Milan
State/Province
Lombardy
ZIP/Postal Code
20100
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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