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

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.

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Key information

Conditions

Urinary Tract Infection Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urinary Tract Infections Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University

Milan, Lombardy, 20100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract

Drug

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

Placebo

Other

Placebo tablet twice a day 7 days before and after surgery

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2015
First posted: Aug 13, 2014
Registry last updated: Aug 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed