Does Post-Operative Prophylaxis With Macrobid Reduce the Incidence of Post-Operative Urinary Tract Infection in Patients Undergoing Placement of a Sub-Urethral Sling for the Treatment of Stress Urinary Incontinence

This study has been completed.
Sponsor:
Collaborator:
Texas A&M University
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00734968
First received: August 12, 2008
Last updated: July 21, 2011
Last verified: February 2009
  Purpose

This project will be a randomized, double blinded, placebo controlled clinical trial. The aim of the trial is to determine whether or not post-operative prophylaxis with macrobid will decrease the incidence of postoperative urinary tract infection in women receiving sub-urethral slings for the treatment of urinary incontinence.


Condition Intervention Phase
Post-Operative Urinary Tract Infection in Patients Undergoing Placement of a Sub-Urethral Sling for the Treatment of Stress Urinary Incontinence
Drug: Nitrofurantoin
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Post-Operative Prophylaxis With Macrobid Reduce the Incidence of Post-Operative Urinary Tract Infection in Patients Undergoing Placement of a Sub-Urethral Sling for the Treatment of Stress Urinary Incontinence: A Randomized, Double Blinded Placebo Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • Incidence of post-operative UTI following the placement of sub-urethral sling for the treatment of stress urinary incontinence [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: May 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively
Drug: Nitrofurantoin
Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence
Placebo Comparator: 2
Arm randomly assigned to receive placebo 1 tablet PO BID x 3 days post-operatively.The incidence of UTI in this group will be compared with group one (1)
Other: Placebo
6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women over the age of 18 who will undergo the placement of a sub-urethral sling for the treatment of stress urinary incontinence

Exclusion Criteria:

  • Exclusion criteria are those with a known allergy to macrobid, those with glucose-6-phosphate deficiency, renal impairment, women breast feeding or with a known pregnancy, patients taking medications for gout, and those with known risk factors for complicated UTI (polycystic renal disease, nephrolithiasis, neurogenic bladder, diabetes, immuno-suppression, etc).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00734968

Locations
United States, Texas
Scott and White Hosptial, Texas A&M University
Temple, Texas, United States, 76508
Sponsors and Collaborators
University of Missouri-Columbia
Texas A&M University
Investigators
Principal Investigator: Daniel L Jackson, M.D. University of Missouri-Columbia
Study Director: Raymond T Foster, M.D., M.S., M.H.Sc. University of Missouri-Columbia
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daniel Jackson, M.D., University of Missouri-Columbia School of Medicine. Department of OB/GYN and Women's Health
ClinicalTrials.gov Identifier: NCT00734968     History of Changes
Other Study ID Numbers: 1108717
Study First Received: August 12, 2008
Last Updated: July 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Missouri-Columbia:
UTI
Urinary tract infection
suburethral sling
Prevention
Nitrofurantoin
Prophylaxis

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urinary Tract Infections
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Infection
Nitrofurantoin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Renal Agents

ClinicalTrials.gov processed this record on April 17, 2014