Trial Outcomes & Findings for Gentamicin Intravesical Efficacy for Infection of Urinary Tract (NCT NCT04246996)
NCT ID: NCT04246996
Last Updated: 2022-11-08
Results Overview
Number of participants in each arm treated with antibiotics for urinary tract infection symptoms
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
370 participants
Primary outcome timeframe
Within 6 weeks after surgery
Results posted on
2022-11-08
Participant Flow
Participant milestones
| Measure |
Gentamicin Arm
At completion of surgery but prior to awakening from anesthesia, after ensuring the bladder is fully drained, 80mg of gentamicin in 50 mL of normal saline will be infused by the surgeon into the participants's bladder through the standard-care transurethral catheter. The surgeon will then clamp the catheter and label the catheter with the clamping time. The catheter will be clamped to prevent the gentamicin from immediately flowing out of the bladder and thus allow the gentamicin time to have an effect. The participant will then proceed as usual to the postoperative anesthesia care unit. The recovery room nurse will unclamp the catheter after 1 hour. The subject will otherwise have usual pre-operative and post-operative care.
gentamicin sulfate: Subjects in the gentamicin arm will receive an bladder instillation of 80mg of gentamicin sulfate in 50 mL of normal saline through a standard-of-care Foley catheter.
|
Control Arm
At the end of the surgery but prior to awakening from anesthesia, after ensuring the bladder is fully drained, the surgeon will clamp the catheter and label the catheter with the clamping time. The purpose of clamping the catheter for participants receiving usual care will be to ensure participants are masked to study arm assignment if they wake up and notice their catheter. The participant will then proceed as usual to the postoperative anesthesia care unit. The recovery room nurse will unclamp the catheter after 1 hour. The participant will otherwise have usual pre-operative and post-operative care.
Catheter clamping only: Participants in the control arm will have their standard-of-care transurethral catheter clamped for 1 hour post-placement to maintain participant masking to study arm.
|
|---|---|---|
|
Overall Study
STARTED
|
185
|
185
|
|
Overall Study
COMPLETED
|
183
|
180
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
Gentamicin Arm
At completion of surgery but prior to awakening from anesthesia, after ensuring the bladder is fully drained, 80mg of gentamicin in 50 mL of normal saline will be infused by the surgeon into the participants's bladder through the standard-care transurethral catheter. The surgeon will then clamp the catheter and label the catheter with the clamping time. The catheter will be clamped to prevent the gentamicin from immediately flowing out of the bladder and thus allow the gentamicin time to have an effect. The participant will then proceed as usual to the postoperative anesthesia care unit. The recovery room nurse will unclamp the catheter after 1 hour. The subject will otherwise have usual pre-operative and post-operative care.
gentamicin sulfate: Subjects in the gentamicin arm will receive an bladder instillation of 80mg of gentamicin sulfate in 50 mL of normal saline through a standard-of-care Foley catheter.
|
Control Arm
At the end of the surgery but prior to awakening from anesthesia, after ensuring the bladder is fully drained, the surgeon will clamp the catheter and label the catheter with the clamping time. The purpose of clamping the catheter for participants receiving usual care will be to ensure participants are masked to study arm assignment if they wake up and notice their catheter. The participant will then proceed as usual to the postoperative anesthesia care unit. The recovery room nurse will unclamp the catheter after 1 hour. The participant will otherwise have usual pre-operative and post-operative care.
Catheter clamping only: Participants in the control arm will have their standard-of-care transurethral catheter clamped for 1 hour post-placement to maintain participant masking to study arm.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Did not meet eligibility criteria
|
1
|
4
|
Baseline Characteristics
Gentamicin Intravesical Efficacy for Infection of Urinary Tract
Baseline characteristics by cohort
| Measure |
Gentamicin Arm
n=183 Participants
At the completion of the subjects surgery but prior to awakening from anesthesia, 80mg of gentamicin in 50 mL of normal saline will be infused into the subject's bladder through the standard-of-care transurethral catheter by the surgeon. The surgeon will then clamp the catheter and label the catheter with the clamping time. The catheter will be clamped to prevent the gentamicin from immediately flowing out of the bladder and thus allow the gentamicin time to have an effect. The subject will then proceed as usual to the postoperative anesthesia care unit. A member of the subject's care team will unclamp the catheter after 1 hour. The subject will otherwise have usual pre-operative and post-operative care.
gentamicin sulfate: Subjects in the gentamicin arm will receive an bladder instillation of 80mg of gentamicin sulfate in 50 mL of normal saline through a standard-of-care Foley catheter.
|
Control Arm
n=180 Participants
If the patient is randomized to no instillation, at the end of the surgery but prior to awakening from anesthesia, the surgeon will clamp the catheter and label the catheter with the clamping time. The purpose of clamping the catheter for subjects receiving usual care will be to ensure patients are masked to study arm assignment if they wake up and notice their catheter. The subject will then proceed as usual to the postoperative anesthesia care unit. A member of the subject's care team will unclamp the catheter after 1 hour. The subject will otherwise have usual pre-operative and post-operative care.
Catheter clamping only: Subjects in the control arm will have their standard-of-care transurethral catheter clamped for 1 hour post-placement to maintain subject masking to study arm.
|
Total
n=363 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.5 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
58.7 years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
58.6 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
183 Participants
n=5 Participants
|
180 Participants
n=7 Participants
|
363 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
Asian
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
70 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
97 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
196 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not specified
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
183 participants
n=5 Participants
|
180 participants
n=7 Participants
|
363 participants
n=5 Participants
|
|
Study site
University of California San Diego
|
122 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
245 Participants
n=5 Participants
|
|
Study site
Kaiser Permanente San Diego
|
61 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Body mass index
|
28.5 kg/m^2
STANDARD_DEVIATION 5.6 • n=5 Participants
|
28.2 kg/m^2
STANDARD_DEVIATION 5.1 • n=7 Participants
|
28.2 kg/m^2
STANDARD_DEVIATION 5.1 • n=5 Participants
|
|
Parity
|
2 births
n=5 Participants
|
2 births
n=7 Participants
|
2 births
n=5 Participants
|
|
American Society of Anesthesiologists (ASA) Physical Status Classification
|
2 units on a scale
n=5 Participants
|
2 units on a scale
n=7 Participants
|
2 units on a scale
n=5 Participants
|
|
Diabetes mellitus
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Current smoker
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Postmenopausal
Yes
|
122 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
238 Participants
n=5 Participants
|
|
Postmenopausal
No
|
47 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Postmenopausal
Unknown
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Current vaginal estrogen use
|
79 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Current menopausal hormone therapy use
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Number of culture positive UTIs in 12 months prior to surgery
0 UTIs
|
155 participants
n=5 Participants
|
156 participants
n=7 Participants
|
311 participants
n=5 Participants
|
|
Number of culture positive UTIs in 12 months prior to surgery
1 UTI
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Number of culture positive UTIs in 12 months prior to surgery
2 UTIs
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Number of culture positive UTIs in 12 months prior to surgery
3 UTIs
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Positive urine culture within 4 weeks before surgery
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 6 weeks after surgeryNumber of participants in each arm treated with antibiotics for urinary tract infection symptoms
Outcome measures
| Measure |
Gentamicin Arm
n=183 Participants
At the completion of the subjects surgery but prior to awakening from anesthesia, 80mg of gentamicin in 50 mL of normal saline will be infused into the subject's bladder through the standard-of-care transurethral catheter by the surgeon. The surgeon will then clamp the catheter and label the catheter with the clamping time. The catheter will be clamped to prevent the gentamicin from immediately flowing out of the bladder and thus allow the gentamicin time to have an effect. The subject will then proceed as usual to the postoperative anesthesia care unit. A member of the subject's care team will unclamp the catheter after 1 hour. The subject will otherwise have usual pre-operative and post-operative care.
gentamicin sulfate: Subjects in the gentamicin arm will receive an bladder instillation of 80mg of gentamicin sulfate in 50 mL of normal saline through a standard-of-care Foley catheter.
|
Control Arm
n=180 Participants
If the patient is randomized to no instillation, at the end of the surgery but prior to awakening from anesthesia, the surgeon will clamp the catheter and label the catheter with the clamping time. The purpose of clamping the catheter for subjects receiving usual care will be to ensure patients are masked to study arm assignment if they wake up and notice their catheter. The subject will then proceed as usual to the postoperative anesthesia care unit. A member of the subject's care team will unclamp the catheter after 1 hour. The subject will otherwise have usual pre-operative and post-operative care.
Catheter clamping only: Subjects in the control arm will have their standard-of-care transurethral catheter clamped for 1 hour post-placement to maintain subject masking to study arm.
|
|---|---|---|
|
Post-operative Urinary Tract Infection
|
19 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Within 6 weeks after surgeryHospital readmissions
Outcome measures
| Measure |
Gentamicin Arm
n=183 Participants
At the completion of the subjects surgery but prior to awakening from anesthesia, 80mg of gentamicin in 50 mL of normal saline will be infused into the subject's bladder through the standard-of-care transurethral catheter by the surgeon. The surgeon will then clamp the catheter and label the catheter with the clamping time. The catheter will be clamped to prevent the gentamicin from immediately flowing out of the bladder and thus allow the gentamicin time to have an effect. The subject will then proceed as usual to the postoperative anesthesia care unit. A member of the subject's care team will unclamp the catheter after 1 hour. The subject will otherwise have usual pre-operative and post-operative care.
gentamicin sulfate: Subjects in the gentamicin arm will receive an bladder instillation of 80mg of gentamicin sulfate in 50 mL of normal saline through a standard-of-care Foley catheter.
|
Control Arm
n=180 Participants
If the patient is randomized to no instillation, at the end of the surgery but prior to awakening from anesthesia, the surgeon will clamp the catheter and label the catheter with the clamping time. The purpose of clamping the catheter for subjects receiving usual care will be to ensure patients are masked to study arm assignment if they wake up and notice their catheter. The subject will then proceed as usual to the postoperative anesthesia care unit. A member of the subject's care team will unclamp the catheter after 1 hour. The subject will otherwise have usual pre-operative and post-operative care.
Catheter clamping only: Subjects in the control arm will have their standard-of-care transurethral catheter clamped for 1 hour post-placement to maintain subject masking to study arm.
|
|---|---|---|
|
Adverse Events
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Within 6 weeks after surgeryOutcome measures
| Measure |
Gentamicin Arm
n=183 Participants
At the completion of the subjects surgery but prior to awakening from anesthesia, 80mg of gentamicin in 50 mL of normal saline will be infused into the subject's bladder through the standard-of-care transurethral catheter by the surgeon. The surgeon will then clamp the catheter and label the catheter with the clamping time. The catheter will be clamped to prevent the gentamicin from immediately flowing out of the bladder and thus allow the gentamicin time to have an effect. The subject will then proceed as usual to the postoperative anesthesia care unit. A member of the subject's care team will unclamp the catheter after 1 hour. The subject will otherwise have usual pre-operative and post-operative care.
gentamicin sulfate: Subjects in the gentamicin arm will receive an bladder instillation of 80mg of gentamicin sulfate in 50 mL of normal saline through a standard-of-care Foley catheter.
|
Control Arm
n=180 Participants
If the patient is randomized to no instillation, at the end of the surgery but prior to awakening from anesthesia, the surgeon will clamp the catheter and label the catheter with the clamping time. The purpose of clamping the catheter for subjects receiving usual care will be to ensure patients are masked to study arm assignment if they wake up and notice their catheter. The subject will then proceed as usual to the postoperative anesthesia care unit. A member of the subject's care team will unclamp the catheter after 1 hour. The subject will otherwise have usual pre-operative and post-operative care.
Catheter clamping only: Subjects in the control arm will have their standard-of-care transurethral catheter clamped for 1 hour post-placement to maintain subject masking to study arm.
|
|---|---|---|
|
Number of Participants With Isolated Uropathogen on Post-operative Urine Culture
|
12 Participants
|
15 Participants
|
Adverse Events
Gentamicin Arm
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Arm
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gentamicin Arm
n=183 participants at risk
At the completion of the subjects surgery but prior to awakening from anesthesia, 80mg of gentamicin in 50 mL of normal saline will be infused into the subject's bladder through the standard-of-care transurethral catheter by the surgeon. The surgeon will then clamp the catheter and label the catheter with the clamping time. The catheter will be clamped to prevent the gentamicin from immediately flowing out of the bladder and thus allow the gentamicin time to have an effect. The subject will then proceed as usual to the postoperative anesthesia care unit. A member of the subject's care team will unclamp the catheter after 1 hour. The subject will otherwise have usual pre-operative and post-operative care.
gentamicin sulfate: Subjects in the gentamicin arm will receive an bladder instillation of 80mg of gentamicin sulfate in 50 mL of normal saline through a standard-of-care Foley catheter.
|
Control Arm
n=180 participants at risk
If the patient is randomized to no instillation, at the end of the surgery but prior to awakening from anesthesia, the surgeon will clamp the catheter and label the catheter with the clamping time. The purpose of clamping the catheter for subjects receiving usual care will be to ensure patients are masked to study arm assignment if they wake up and notice their catheter. The subject will then proceed as usual to the postoperative anesthesia care unit. A member of the subject's care team will unclamp the catheter after 1 hour. The subject will otherwise have usual pre-operative and post-operative care.
Catheter clamping only: Subjects in the control arm will have their standard-of-care transurethral catheter clamped for 1 hour post-placement to maintain subject masking to study arm.
|
|---|---|---|
|
Gastrointestinal disorders
Small bowel obstruction
|
0.00%
0/183 • 6 weeks after surgery
Hospital readmission within 6 weeks after surgery as reported by patient or found in electronic medical record
|
0.56%
1/180 • 6 weeks after surgery
Hospital readmission within 6 weeks after surgery as reported by patient or found in electronic medical record
|
|
Surgical and medical procedures
Reoperation for hematoma
|
0.55%
1/183 • 6 weeks after surgery
Hospital readmission within 6 weeks after surgery as reported by patient or found in electronic medical record
|
0.00%
0/180 • 6 weeks after surgery
Hospital readmission within 6 weeks after surgery as reported by patient or found in electronic medical record
|
|
Infections and infestations
Pelvic abscess
|
0.55%
1/183 • 6 weeks after surgery
Hospital readmission within 6 weeks after surgery as reported by patient or found in electronic medical record
|
0.00%
0/180 • 6 weeks after surgery
Hospital readmission within 6 weeks after surgery as reported by patient or found in electronic medical record
|
|
Nervous system disorders
Ischemic stroke
|
0.00%
0/183 • 6 weeks after surgery
Hospital readmission within 6 weeks after surgery as reported by patient or found in electronic medical record
|
0.56%
1/180 • 6 weeks after surgery
Hospital readmission within 6 weeks after surgery as reported by patient or found in electronic medical record
|
|
Endocrine disorders
Diabetic Ketoacidosis
|
0.00%
0/183 • 6 weeks after surgery
Hospital readmission within 6 weeks after surgery as reported by patient or found in electronic medical record
|
0.56%
1/180 • 6 weeks after surgery
Hospital readmission within 6 weeks after surgery as reported by patient or found in electronic medical record
|
|
Injury, poisoning and procedural complications
Uncontrolled postoperative pain
|
0.55%
1/183 • 6 weeks after surgery
Hospital readmission within 6 weeks after surgery as reported by patient or found in electronic medical record
|
0.00%
0/180 • 6 weeks after surgery
Hospital readmission within 6 weeks after surgery as reported by patient or found in electronic medical record
|
|
Gastrointestinal disorders
Acute cholecystitis
|
0.55%
1/183 • 6 weeks after surgery
Hospital readmission within 6 weeks after surgery as reported by patient or found in electronic medical record
|
0.00%
0/180 • 6 weeks after surgery
Hospital readmission within 6 weeks after surgery as reported by patient or found in electronic medical record
|
|
Surgical and medical procedures
Admitted for planned breast surgery
|
0.55%
1/183 • 6 weeks after surgery
Hospital readmission within 6 weeks after surgery as reported by patient or found in electronic medical record
|
0.00%
0/180 • 6 weeks after surgery
Hospital readmission within 6 weeks after surgery as reported by patient or found in electronic medical record
|
|
Renal and urinary disorders
Reoperation for sling division
|
0.00%
0/183 • 6 weeks after surgery
Hospital readmission within 6 weeks after surgery as reported by patient or found in electronic medical record
|
0.56%
1/180 • 6 weeks after surgery
Hospital readmission within 6 weeks after surgery as reported by patient or found in electronic medical record
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration pneumonia
|
0.00%
0/183 • 6 weeks after surgery
Hospital readmission within 6 weeks after surgery as reported by patient or found in electronic medical record
|
0.56%
1/180 • 6 weeks after surgery
Hospital readmission within 6 weeks after surgery as reported by patient or found in electronic medical record
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/183 • 6 weeks after surgery
Hospital readmission within 6 weeks after surgery as reported by patient or found in electronic medical record
|
0.56%
1/180 • 6 weeks after surgery
Hospital readmission within 6 weeks after surgery as reported by patient or found in electronic medical record
|
Other adverse events
Adverse event data not reported
Additional Information
Mary Rieger, MD, MAS
Dell Medical School at The University of Texas at Austin
Phone: 512-324-7036
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place