Does Treatment With Macrobid Reduce Urinary Tract Infections in Patients Receiving a Sub-Urethral Sling for Incontinence
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|ClinicalTrials.gov Identifier: NCT00734968|
Recruitment Status : Completed
First Posted : August 14, 2008
Results First Posted : October 11, 2016
Last Update Posted : October 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Stress Incontinence||Drug: Nitrofurantoin Other: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||161 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Start Date :||May 2008|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2010|
Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively
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 Name: Macrobid
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)
6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets.
- 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%.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00734968
|United States, Texas|
|Scott and White Hosptial, Texas A&M University|
|Temple, Texas, United States, 76508|
|Principal Investigator:||Daniel L Jackson, M.D.||University of Missouri-Columbia|
|Study Director:||Raymond T Foster, MD, MS, MHSc||University of Missouri-Columbia|