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Does Treatment With Macrobid Reduce Urinary Tract Infections in Patients Receiving a Sub-Urethral Sling for Incontinence

This study has been completed.
Sponsor:
Collaborator:
Texas A&M University
Information provided by (Responsible Party):
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00734968
First received: August 12, 2008
Last updated: August 17, 2016
Last verified: August 2016
  Purpose
This project will determine whether 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
Stress 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 Prophylaxis With Macrobid Reduce the Incidence of Urinary Tract Infection in Patients Who Receive a Sub-Urethral Sling for the Treatment of Stress Urinary Incontinence: 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 ]
    The overall rate of UTI following the placement of sub-urethral sling for the treatment of stress urinary incontinence in our study was 24.8% (n = 37)

  • Incidence of Post-operative UTI in Placebo Group [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The incidence of UTI in the placebo group was 32%.

  • Incidence of Post-operative UTI in Treatment Group [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The incidence of UTI in the nitrofurantoin group was 17.6%.


Enrollment: 161
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: Treatment
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
Other Name: Macrobid
Placebo Comparator: Placebo
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.

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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, MD, MS, MHSc University of Missouri-Columbia
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00734968     History of Changes
Other Study ID Numbers: 1108717 
Study First Received: August 12, 2008
Results First Received: May 20, 2016
Last Updated: August 17, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

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

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

ClinicalTrials.gov processed this record on December 08, 2016