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

This study has been completed.
Sponsor:
Collaborator:
Texas A&M University
Information provided by (Responsible Party):
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00734968
First received: August 12, 2008
Last updated: August 17, 2016
Last verified: August 2016
Results First Received: May 20, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Stress Incontinence
Interventions: Drug: Nitrofurantoin
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
161 subjects were consecutively enrolled. 8 subjects were lost to protocol errors. 76 subjects were randomized to treatment and 77 to placebo. 1 subject from each arm was lost to follow up. 75 subjects in the treatment arm and 76 in the placebo arm were in the final analysis.

Reporting Groups
  Description
Placebo

Arm randomly assigned to receive placebo 1 tablet PO twice a day (BID) x 3 days post-operatively. The incidence of urinary tract infection (UTI) in this group will be compared with group one (1).

Placebo: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100 mg tablets.

Treatment

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

Nitrofurantoin: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence


Participant Flow:   Overall Study
    Placebo   Treatment
STARTED   77   76 
COMPLETED   76   75 
NOT COMPLETED   1   1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment

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

Nitrofurantoin: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence

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)

Placebo: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets.

Total Total of all reporting groups

Baseline Measures
   Treatment   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 75   76   151 
Age, Customized 
[Units: Participants]
     
>18 years   75   76   151 
Gender 
[Units: Participants]
     
Female   75   76   151 
Male   0   0   0 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   70   70   140 
Black   1   1   2 
Hispanic   4   5   9 
Region of Enrollment 
[Units: Participants]
     
United States   75   76   151 


  Outcome Measures
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1.  Primary:   Incidence of Post-operative UTI Following the Placement of Sub-urethral Sling for the Treatment of Stress Urinary Incontinence   [ Time Frame: 6 weeks ]

2.  Primary:   Incidence of Post-operative UTI in Placebo Group   [ Time Frame: 6 weeks ]

3.  Primary:   Incidence of Post-operative UTI in Treatment Group   [ Time Frame: 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Daniel Jackson MD
Organization: University of Missouri
phone: 573 499 6041
e-mail: jacksondl@health.missouri.edu


Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00734968     History of Changes
Other Study ID Numbers: 1108717
Study First Received: August 12, 2008
Results First Received: May 20, 2016
Last Updated: August 17, 2016
Health Authority: United States: Institutional Review Board