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

San Donato Group (GSD)

Status: Completed

Conditions: Urinary Tract Infection; Pelvic Organ Prolapse; Urinary Incontinence

Treatments: Drug: L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02216253

UTI 2014

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract

Active Comparator group

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

Treatment:

Drug: L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract

Placebo

Placebo Comparator group

Description:

Placebo tablet twice a day 7 days before and after surgery

Treatment:

Other: Placebo