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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2015

Interventions

  • 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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • IRCCS San Raffaele
  • Provider of Information About this Clinical Study
    • Principal Investigator: Umberto Leone Roberti Maggiore, MD – IRCCS San Raffaele
  • Overall Official(s)
    • Umberto Leone Roberti Maggiore, MD, Principal Investigator, IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University
    • Stefano Salvatore, MD, Study Director, IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University

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