Trial Outcomes & Findings for Nitrofurantoin Administration for the Prevention of Short-Term Catheter Associated Urinary Tract Infection After Pelvic Surgery (NCT NCT03287089)
NCT ID: NCT03287089
Last Updated: 2022-08-09
Results Overview
Number of participants with a urinary tract infection in the first 30 days following pelvic reconstructive surgery
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
164 participants
Primary outcome timeframe
within 30 days of surgery
Results posted on
2022-08-09
Participant Flow
Consecutive women were prescreened for eligibility and introduced to the study prior to surgery. Women with postoperative urinary retention following pelvic organ prolapse and/or incontinence surgery were approached for study inclusion at the time of their postoperative in-office voiding trial between September 2017 and April 2019.
Women were deemed as "enrolled" once they consented and randomized. No enrolled participants were excluded with this definition.
Participant milestones
| Measure |
Nitrofurantoin
Receives twice daily 100mg nitrofurantoin for 5 days following catheter removal
Nitrofurantoin 100 MG: Patients will receive nitrofurantoin 100mg twice daily by mouth for 5 days
|
Placebo
Receives twice daily matching placebo for 5 days following catheter removal
Placebo Oral Tablet: Matching placebo
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
82
|
|
Overall Study
COMPLETED
|
82
|
76
|
|
Overall Study
NOT COMPLETED
|
0
|
6
|
Reasons for withdrawal
| Measure |
Nitrofurantoin
Receives twice daily 100mg nitrofurantoin for 5 days following catheter removal
Nitrofurantoin 100 MG: Patients will receive nitrofurantoin 100mg twice daily by mouth for 5 days
|
Placebo
Receives twice daily matching placebo for 5 days following catheter removal
Placebo Oral Tablet: Matching placebo
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Nitrofurantoin Administration for the Prevention of Short-Term Catheter Associated Urinary Tract Infection After Pelvic Surgery
Baseline characteristics by cohort
| Measure |
Nitrofurantoin
n=82 Participants
Receives twice daily 100mg nitrofurantoin for 5 days following catheter removal
Nitrofurantoin 100 MG: Patients will receive nitrofurantoin 100mg twice daily by mouth for 5 days
|
Placebo
n=82 Participants
Receives twice daily matching placebo for 5 days following catheter removal
Placebo Oral Tablet: Matching placebo
|
Total
n=164 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.6 years
STANDARD_DEVIATION 11.7 • n=39 Participants
|
61.1 years
STANDARD_DEVIATION 12.4 • n=41 Participants
|
61.4 years
STANDARD_DEVIATION 12.0 • n=35 Participants
|
|
Sex/Gender, Customized
Female
|
82 Participants
n=39 Participants
|
82 Participants
n=41 Participants
|
164 Participants
n=35 Participants
|
|
Sex/Gender, Customized
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
79 Participants
n=39 Participants
|
72 Participants
n=41 Participants
|
151 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Body Mass Index (BMI), kg/m^2
|
27.1 kg/m^2
STANDARD_DEVIATION 4.7 • n=39 Participants
|
28.6 kg/m^2
STANDARD_DEVIATION 5 • n=41 Participants
|
27.8 kg/m^2
STANDARD_DEVIATION 4.9 • n=35 Participants
|
|
Parity
|
2 Parity
n=39 Participants
|
2 Parity
n=41 Participants
|
2 Parity
n=35 Participants
|
|
POP-Q Stage
|
2 units on a scale
n=39 Participants
|
2 units on a scale
n=41 Participants
|
2 units on a scale
n=35 Participants
|
|
Menopausal Status
Premenopausal
|
18 Participants
n=39 Participants
|
17 Participants
n=41 Participants
|
35 Participants
n=35 Participants
|
|
Menopausal Status
Postmenopausal
|
64 Participants
n=39 Participants
|
64 Participants
n=41 Participants
|
128 Participants
n=35 Participants
|
|
Menopausal Status
Missing data
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Postmenopausal Hormone Use
No Hormone Therapy
|
58 Participants
n=39 Participants
|
58 Participants
n=41 Participants
|
116 Participants
n=35 Participants
|
|
Postmenopausal Hormone Use
Vaginal Estrogen Therapy
|
20 Participants
n=39 Participants
|
19 Participants
n=41 Participants
|
39 Participants
n=35 Participants
|
|
Postmenopausal Hormone Use
Systemic Hormonal Therapy
|
4 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Current Smoking
|
6 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
|
History of Recurrent UTI
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Diabetes Mellitus
|
9 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
19 Participants
n=35 Participants
|
|
Preoperative PVR Volume (mL)
|
57.9 mL
STANDARD_DEVIATION 92.6 • n=39 Participants
|
45.3 mL
STANDARD_DEVIATION 55.7 • n=41 Participants
|
51.4 mL
STANDARD_DEVIATION 75.5 • n=35 Participants
|
|
Creatinine Clearance
|
84.1 mL/min
STANDARD_DEVIATION 30.1 • n=39 Participants
|
94.2 mL/min
STANDARD_DEVIATION 34.9 • n=41 Participants
|
89.1 mL/min
STANDARD_DEVIATION 32.9 • n=35 Participants
|
|
Type of Procedure
Mid urethral sling surgery
|
50 Participants
n=39 Participants
|
47 Participants
n=41 Participants
|
97 Participants
n=35 Participants
|
|
Type of Procedure
Burch colposuspension
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Type of Procedure
Anterior repair
|
15 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
35 Participants
n=35 Participants
|
|
Type of Procedure
Posterior repair
|
53 Participants
n=39 Participants
|
59 Participants
n=41 Participants
|
112 Participants
n=35 Participants
|
|
Type of Procedure
Hysterectomy
|
32 Participants
n=39 Participants
|
35 Participants
n=41 Participants
|
67 Participants
n=35 Participants
|
|
Type of Procedure
Vaginectomy/colpocleisis
|
7 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Type of Procedure
Uterosacral ligament suspension
|
18 Participants
n=39 Participants
|
24 Participants
n=41 Participants
|
42 Participants
n=35 Participants
|
|
Type of Procedure
Sacrospinous ligament fixation
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Type of Procedure
Iliococcygeus vault suspension
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Type of Procedure
Sacral colpopexy
|
4 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Type of Procedure
Vaginal mesh excision
|
4 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Operative Time (mins)
|
134 minutes
STANDARD_DEVIATION 80.8 • n=39 Participants
|
142.9 minutes
STANDARD_DEVIATION 86.9 • n=41 Participants
|
138.4 minutes
STANDARD_DEVIATION 83.8 • n=35 Participants
|
|
Estimated Blood Loss (mL)
|
45.5 mL
STANDARD_DEVIATION 35.5 • n=39 Participants
|
60.9 mL
STANDARD_DEVIATION 61.6 • n=41 Participants
|
53.2 mL
STANDARD_DEVIATION 50.7 • n=35 Participants
|
|
Length of Hospital Stay (days)
|
1 days
n=39 Participants
|
1 days
n=41 Participants
|
1 days
n=35 Participants
|
|
Duration of Catheterization (days)
|
3 days
n=39 Participants
|
3 days
n=41 Participants
|
3 days
n=35 Participants
|
PRIMARY outcome
Timeframe: within 30 days of surgeryNumber of participants with a urinary tract infection in the first 30 days following pelvic reconstructive surgery
Outcome measures
| Measure |
Nitrofurantoin
n=82 Participants
Receives twice daily 100mg nitrofurantoin for 5 days following catheter removal
Nitrofurantoin 100 MG: Patients will receive nitrofurantoin 100mg twice daily by mouth for 5 days
|
Placebo
n=82 Participants
Receives twice daily matching placebo for 5 days following catheter removal
Placebo Oral Tablet: Matching placebo
|
|---|---|---|
|
UTI
|
15 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: within 30 days of surgeryPopulation: This is the total number of participants with an allergy or intolerance to the study medication.These adverse symptoms included: hives, pruritus, rash, anaphylaxis, nausea, vomiting, diarrhea, and other.
Number of participants with an adverse event only related to study drug administration
Outcome measures
| Measure |
Nitrofurantoin
n=5 Participants
Receives twice daily 100mg nitrofurantoin for 5 days following catheter removal
Nitrofurantoin 100 MG: Patients will receive nitrofurantoin 100mg twice daily by mouth for 5 days
|
Placebo
n=4 Participants
Receives twice daily matching placebo for 5 days following catheter removal
Placebo Oral Tablet: Matching placebo
|
|---|---|---|
|
Adverse Events
Allergy
|
0 Participants
|
0 Participants
|
|
Adverse Events
Nausea
|
5 Participants
|
2 Participants
|
|
Adverse Events
Vomiting
|
0 Participants
|
0 Participants
|
|
Adverse Events
Diarrhea
|
0 Participants
|
0 Participants
|
|
Adverse Events
Other
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: within 30 days of surgeryPopulation: Compliance was defined as the number pills taken divided by total number of pills dispensed (10). The closer this ratio is to "1" the better the compliance. The closer the ratio is to "0" the worse the compliance
Compliance assessed by use of a medication diary during treatment period
Outcome measures
| Measure |
Nitrofurantoin
n=82 Participants
Receives twice daily 100mg nitrofurantoin for 5 days following catheter removal
Nitrofurantoin 100 MG: Patients will receive nitrofurantoin 100mg twice daily by mouth for 5 days
|
Placebo
n=82 Participants
Receives twice daily matching placebo for 5 days following catheter removal
Placebo Oral Tablet: Matching placebo
|
|---|---|---|
|
Medication Compliance
|
0.95 ratio
Standard Deviation 0.18
|
0.96 ratio
Standard Deviation 0.15
|
Adverse Events
Nitrofurantoin
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nitrofurantoin
n=82 participants at risk
Receives twice daily 100mg nitrofurantoin for 5 days following catheter removal
Nitrofurantoin 100 MG: Patients will receive nitrofurantoin 100mg twice daily by mouth for 5 days
|
Placebo
n=82 participants at risk
Receives twice daily matching placebo for 5 days following catheter removal
Placebo Oral Tablet: Matching placebo
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Medication Intolerance
|
0.00%
0/82 • 30 days (from surgery until 30 days postop)
Adverse events data related to study medication was collected (i.e. allergies and/or intolerances)
|
1.2%
1/82 • Number of events 1 • 30 days (from surgery until 30 days postop)
Adverse events data related to study medication was collected (i.e. allergies and/or intolerances)
|
|
Gastrointestinal disorders
Medication Intolerance
|
6.1%
5/82 • Number of events 5 • 30 days (from surgery until 30 days postop)
Adverse events data related to study medication was collected (i.e. allergies and/or intolerances)
|
2.4%
2/82 • Number of events 2 • 30 days (from surgery until 30 days postop)
Adverse events data related to study medication was collected (i.e. allergies and/or intolerances)
|
|
General disorders
Medication Intolerance
|
0.00%
0/82 • 30 days (from surgery until 30 days postop)
Adverse events data related to study medication was collected (i.e. allergies and/or intolerances)
|
1.2%
1/82 • Number of events 1 • 30 days (from surgery until 30 days postop)
Adverse events data related to study medication was collected (i.e. allergies and/or intolerances)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place