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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

August 12, 2008
August 17, 2016
May 2008
May 2010   (final data collection date for primary outcome measure)
  • 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%.
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 ]
Complete list of historical versions of study NCT00734968 on ClinicalTrials.gov Archive Site
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Does Treatment With Macrobid Reduce Urinary Tract Infections in Patients Receiving a Sub-Urethral Sling for Incontinence
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
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.
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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Stress Incontinence
  • 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
  • Other: Placebo
    6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets.
  • Experimental: Treatment
    Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively
    Intervention: Drug: Nitrofurantoin
  • 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)
    Intervention: Other: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
161
May 2010
May 2010   (final data collection date for primary outcome measure)

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).
Female
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00734968
1108717
Yes
Undecided
Not Provided
University of Missouri-Columbia
University of Missouri-Columbia
Texas A&M University
Principal Investigator: Daniel L Jackson, M.D. University of Missouri-Columbia
Study Director: Raymond T Foster, MD, MS, MHSc University of Missouri-Columbia
University of Missouri-Columbia
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP