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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02216253

Enrollment

150

Registered

2014-08-13

Start date

2014-10-31

Completion date

Unknown

Last updated

2015-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse, Urinary Incontinence, Urinary Tract Infection

Keywords

Urinary tract infection, Pelvic organ prolapse, Urinary incontinence, Stress urinary incontinence, Mixed Urinary incontinence, L-methionine, Placebo

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.

Interventions

DRUGL-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

OTHERPlacebo

Placebo tablet twice a day 7 days before and after surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Treatment for urinary tract infection after surgery.	3 weeks after surgery.	To assess any treatment received for clinically suspected or culture-proven urinary tract infection within 3 weeks of surgery.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026