At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 161 enrolled
Drug / intervention
Nitrofurantoin +1 moredrug
Likely dose
Nitrofurantoin 100mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Nitrofurantoin and Placebo for Stress Incontinence. Completed, enrolled 161 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStress Incontinence
CountriesUnited States
CollaboratorsTexas A&M University
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2008
First PostedAug 2008
Primary CompletionMay 2010
TodayJul 2026
First PostedAug 14, 2008
Enrollment StartMay 1, 2008
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 17.9 years ago
Interventions
Nitrofurantoindrug
Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence
Placeboother
6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets.