NCT02216253

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Last Updated

August 26, 2015

Status Verified

August 1, 2015

Enrollment Period

10 months

First QC Date

August 9, 2014

Last Update Submit

August 24, 2015

Conditions

Urinary Tract InfectionPelvic Organ ProlapseUrinary Incontinence

Keywords

Urinary tract infectionPelvic organ prolapseUrinary incontinenceStress urinary incontinenceMixed Urinary incontinenceL-methioninePlacebo

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

Placebo tablet twice a day 7 days before and after surgery

Other: Placebo

Interventions

L-methionine, Hibiscus Sabdariffa and Boswellia Leaf ExtractDRUG

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

L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract
PlaceboOTHER

Placebo tablet twice a day 7 days before and after surgery

Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • postoperative transurethral catheterization after surgery for pelvic organ prolapse and/or urinary incontinence
  • patients aged ≥ 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University

Milan, Lombardy, 20100, Italy

Location

MeSH Terms

Conditions

Urinary Tract InfectionsPelvic Organ ProlapseUrinary IncontinenceUrinary Incontinence, Stress

Interventions

Methionine

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUrination DisordersLower Urinary Tract SymptomsUrological ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino Acids, EssentialAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Neutral

Study Officials

  • Umberto Leone Roberti Maggiore, MD

    IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University

    PRINCIPAL INVESTIGATOR

  • Stefano Salvatore, MD

    IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 9, 2014

First Posted

August 13, 2014

Study Start

October 1, 2014

Primary Completion

August 1, 2015

Last Updated

August 26, 2015

Record last verified: 2015-08

Locations

IT(1)