Phase 4
N=153
Does Treatment With Macrobid Reduce Urinary Tract Infections in Patients Receiving a Sub-Urethral Sling for Incontinence
Stress Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT00734968 ↗Enrolled (actual)
153
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: Incidence of Post-operative UTI Following the Placement of Sub-urethral Sling for the Treatment of Stress Urinary Incontinence — 13; 24 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Nitrofurantoin (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Missouri-Columbia
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Post-operative UTI Following the Placement of Sub-urethral Sling for the Treatment of Stress Urinary Incontinence |
13; 24 | — |
| PRIMARY Incidence of Post-operative UTI in Placebo Group |
13; 24 | — |
| PRIMARY Incidence of Post-operative UTI in Treatment Group |
13; 24 | — |
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.
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).
Data sourced from ClinicalTrials.gov (NCT00734968). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.