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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Lower Urinary Tract Symptoms
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 August 01, 2014