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

Study Overview
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Brief Summary
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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.

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

Conditions
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Urinary Tract Infection, Pelvic Organ Prolapse, Urinary Incontinence

Intervention / Treatment
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* Drug: L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract<br>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<br>* L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract tablet twice a day 7 days before and after surgery<br>|
| Placebo Comparator: Placebo<br>Placebo tablet twice a day 7 days before and after surgery | Other: Placebo<br>* Placebo tablet twice a day 7 days before and after surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary tract infection, Pelvic organ prolapse, Urinary incontinence, Stress urinary incontinence, Mixed Urinary incontinence, L-methionine, Placebo