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.
Full Title of Study: “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
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: May 2010
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.
- 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: Placebo
- 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets.
Arms, Groups and Cohorts
- Experimental: Treatment
- Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively
- 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)
Clinical Trial 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
- 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
- The incidence of UTI in the placebo group was 32%.
- Incidence of Post-operative UTI in Treatment Group
- Time Frame: 6 weeks
- The incidence of UTI in the nitrofurantoin group was 17.6%.
Participating in This Clinical Trial
- 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 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).
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- University of Missouri-Columbia
- Texas A&M University
- Provider of Information About this Clinical Study
- Overall Official(s)
- Daniel L Jackson, M.D., Principal Investigator, University of Missouri-Columbia
- Raymond T Foster, MD, MS, MHSc, Study Director, University of Missouri-Columbia
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