Clinical trial NCT00734968: Does Treatment With Macrobid Reduce Urinary Tract Infections in Patients Receiving a Sub-Urethral Sling for Incontinence
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stress Incontinence
Keywords: Urinary tract infection (UTI)
suburethral sling
Prevention
Nitrofurantoin
Prophylaxis
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: Texas A&M University
First posted: 2008-08-14
Enrollment: 161
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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).

Primary outcomes:
measure: Incidence of Post-operative UTI Following the Placement of Sub-urethral Sling for the Treatment of Stress Urinary Incontinence
timeFrame: 6 weeks
measure: Incidence of Post-operative UTI in Placebo Group
timeFrame: 6 weeks
measure: Incidence of Post-operative UTI in Treatment Group
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Temple
country: United States
facility: Scott and White Hosptial, Texas A&M University
state: Texas
Study officials:
affiliation: University of Missouri-Columbia
name: Daniel L Jackson, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Missouri-Columbia
name: Raymond T Foster, MD, MS, MHSc
role: STUDY_DIRECTOR
References:
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