MedTrace Logo

Gentamicin Intravesical Efficacy for Infection of Urinary Tract

NCT04246996 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2022-11-08

Study results available
· View outcomes & findings →

Summary

Urinary tract infection (UTI) is a common problem after surgery for pelvic organ prolapse and stress urinary incontinence. This prospective, randomized, single-masked (subject), two-parallel armed study aims to determine the effect of a single postoperative intravesical instillation of 80 mg of gentamicin sulfate in 50 mL of saline versus usual care on the proportion of women treated for UTI within 6 weeks following surgery for pelvic organ prolapse (POP) or stress urinary incontinence (SUI).

Conditions

  • Postoperative Urinary Tract Infection
  • Pelvic Organ Prolapse
  • Stress Urinary Incontinence

Interventions

DRUG

gentamicin sulfate

Subjects in the gentamicin arm will receive an bladder instillation of 80mg of gentamicin sulfate in 50 mL of normal saline through a standard-of-care Foley catheter.

OTHER

Catheter clamping only

Subjects in the control arm will have their standard-of-care transurethral catheter clamped for 1 hour post-placement to maintain subject masking to study arm.

Sponsors & Collaborators

Principal Investigators

  • Kimberly L Ferrante, M.D., M.A.S. · Kaiser Permanente

  • Marianna Alperin, M.D., M.S. · UC San Diego Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-29
Primary Completion
2021-12-05
Completion
2021-12-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04246996 on ClinicalTrials.gov