Trial Outcomes & Findings for Does Treatment With Macrobid Reduce Urinary Tract Infections in Patients Receiving a Sub-Urethral Sling for Incontinence (NCT NCT00734968)
NCT ID: NCT00734968
Last Updated: 2016-10-11
Results Overview
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)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
161 participants
Primary outcome timeframe
6 weeks
Results posted on
2016-10-11
Participant Flow
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.
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
77
|
76
|
|
Overall Study
COMPLETED
|
76
|
75
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Does Treatment With Macrobid Reduce Urinary Tract Infections in Patients Receiving a Sub-Urethral Sling for Incontinence
Baseline characteristics by cohort
| Measure |
Treatment
n=75 Participants
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
n=76 Participants
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
n=151 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
>18 years
|
75 participants
n=5 Participants
|
76 participants
n=7 Participants
|
151 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
70 participants
n=5 Participants
|
70 participants
n=7 Participants
|
140 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
75 participants
n=5 Participants
|
76 participants
n=7 Participants
|
151 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksThe 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)
Outcome measures
| Measure |
Treatment
n=75 Participants
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
n=76 Participants
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.
|
|---|---|---|
|
Incidence of Post-operative UTI Following the Placement of Sub-urethral Sling for the Treatment of Stress Urinary Incontinence
|
13 participants
|
24 participants
|
PRIMARY outcome
Timeframe: 6 weeksThe incidence of UTI in the placebo group was 32%.
Outcome measures
| Measure |
Treatment
n=75 Participants
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
n=76 Participants
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.
|
|---|---|---|
|
Incidence of Post-operative UTI in Placebo Group
|
13 participants
|
24 participants
|
PRIMARY outcome
Timeframe: 6 weeksThe incidence of UTI in the nitrofurantoin group was 17.6%.
Outcome measures
| Measure |
Treatment
n=75 Participants
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
n=76 Participants
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.
|
|---|---|---|
|
Incidence of Post-operative UTI in Treatment Group
|
13 participants
|
24 participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place