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

Primary Purpose

Stress Incontinence

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Nitrofurantoin
Placebo
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Incontinence focused on measuring Urinary tract infection (UTI), suburethral sling, Prevention, Nitrofurantoin, Prophylaxis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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).

Sites / Locations

  • Scott and White Hosptial, Texas A&M University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment

Placebo

Arm Description

Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively

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)

Outcomes

Primary Outcome Measures

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)
Incidence of Post-operative UTI in Placebo Group
The incidence of UTI in the placebo group was 32%.
Incidence of Post-operative UTI in Treatment Group
The incidence of UTI in the nitrofurantoin group was 17.6%.

Secondary Outcome Measures

Full Information

First Posted
August 12, 2008
Last Updated
August 17, 2016
Sponsor
University of Missouri-Columbia
Collaborators
Texas A&M University
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1. Study Identification

Unique Protocol Identification Number
NCT00734968
Brief Title
Does Treatment With Macrobid Reduce Urinary Tract Infections in Patients Receiving a Sub-Urethral Sling for Incontinence
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 Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Missouri-Columbia
Collaborators
Texas A&M University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Incontinence
Keywords
Urinary tract infection (UTI), suburethral sling, Prevention, Nitrofurantoin, Prophylaxis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
161 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Nitrofurantoin
Other Intervention Name(s)
Macrobid
Intervention Description
Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets.
Primary Outcome Measure Information:
Title
Incidence of Post-operative UTI Following the Placement of Sub-urethral Sling for the Treatment of Stress Urinary Incontinence
Description
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)
Time Frame
6 weeks
Title
Incidence of Post-operative UTI in Placebo Group
Description
The incidence of UTI in the placebo group was 32%.
Time Frame
6 weeks
Title
Incidence of Post-operative UTI in Treatment Group
Description
The incidence of UTI in the nitrofurantoin group was 17.6%.
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel L Jackson, M.D.
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raymond T Foster, MD, MS, MHSc
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Study Director
Facility Information:
Facility Name
Scott and White Hosptial, Texas A&M University
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Does Treatment With Macrobid Reduce Urinary Tract Infections in Patients Receiving a Sub-Urethral Sling for Incontinence

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