Stress Incontinence
Conditions
Keywords
Urinary tract infection (UTI), suburethral sling, Prevention, Nitrofurantoin, Prophylaxis
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.
Interventions
DRUGNitrofurantoin
Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence
OTHERPlacebo
6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets.
Sponsors
Texas A&M University
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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%. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 75 |
| 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. | 76 |
| Total | 151 |
Baseline characteristics
| Characteristic | Placebo | Treatment | Total |
|---|---|---|---|
| Age, Customized >18 years | 76 participants | 75 participants | 151 participants |
| Race/Ethnicity, Customized Black | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Hispanic | 5 participants | 4 participants | 9 participants |
| Race/Ethnicity, Customized White | 70 participants | 70 participants | 140 participants |
| Region of Enrollment United States | 76 participants | 75 participants | 151 participants |
| Sex: Female, Male Female | 76 Participants | 75 Participants | 151 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 76 | 0 / 75 |
| serious Total, serious adverse events | 0 / 76 | 0 / 75 |
Outcome results
Primary
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)
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Incidence of Post-operative UTI Following the Placement of Sub-urethral Sling for the Treatment of Stress Urinary Incontinence | 13 participants |
| Placebo | Incidence of Post-operative UTI Following the Placement of Sub-urethral Sling for the Treatment of Stress Urinary Incontinence | 24 participants |
Primary
Incidence of Post-operative UTI in Placebo Group
The incidence of UTI in the placebo group was 32%.
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Incidence of Post-operative UTI in Placebo Group | 13 participants |
| Placebo | Incidence of Post-operative UTI in Placebo Group | 24 participants |
Primary
Incidence of Post-operative UTI in Treatment Group
The incidence of UTI in the nitrofurantoin group was 17.6%.
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Incidence of Post-operative UTI in Treatment Group | 13 participants |
| Placebo | Incidence of Post-operative UTI in Treatment Group | 24 participants |