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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Stress Incontinence

Intervention / Treatment
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* Drug: Nitrofurantoin
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively | Drug: Nitrofurantoin<br>* Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence<br>* Other names: Macrobid;|
| Placebo Comparator: Placebo<br>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<br>* 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Post-operative UTI Following the Placement of Sub-urethral Sling for the Treatment of Stress Urinary Incontinence | 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) | 6 weeks | 
| Incidence of Post-operative UTI in Placebo Group | The incidence of UTI in the placebo group was 32%. | 6 weeks | 
| Incidence of Post-operative UTI in Treatment Group | The incidence of UTI in the nitrofurantoin group was 17.6%. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prophylaxis, Urinary tract infection (UTI), suburethral sling, Prevention, Nitrofurantoin