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

Phase 4

Completed

• Conditions: Stress Incontinence
• Interventions: Other: Placebo; Drug: Nitrofurantoin

• Registration Number: NCT00734968
• Lead Sponsor: University of Missouri-Columbia

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-08-12
• Study First Submitted QC: 2008-08-13
• Study First Posted: 2008-08-14
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Results First Submitted: 2016-05-20
• Status Verified: 2016-08
• Results First Submitted QC: 2016-08-17
• Last Update Submitted: 2016-08-17
• Results First Posted: 2016-10-11
• Last Update Posted: 2016-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 161

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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)
Treatment	Nitrofurantoin	Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively

Primary Outcome Measures

Name	Time	Method
Incidence of Post-operative UTI Following the Placement of Sub-urethral Sling for the Treatment of Stress Urinary Incontinence	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	6 weeks	The incidence of UTI in the placebo group was 32%.
Incidence of Post-operative UTI in Treatment Group	6 weeks	The incidence of UTI in the nitrofurantoin group was 17.6%.

Trial Locations

Locations (1)

Scott and White Hosptial, Texas A&M University; 🇺🇸 Temple, Texas, United States