Trial Outcomes & Findings for Gentamicin Bladder Instillations to Prevent Urinary Tract Infections in Patients With Spinal Cord Injury (NCT NCT03503513)
NCT ID: NCT03503513
Last Updated: 2024-06-25
Results Overview
Number of reported urinary tract infections (UTI) by participants and documented in medical chart, per person across months pre and post treatment. The number of UTIs over time was determined by establishing a per person-month rate made up of the total number of UTIs pre and during treatment (numerator) for the sample divided by the total number of persons/ 6 months (11 participants over 6 months period = 66) as the denominator. The unit of measure is defined as pre and during treatment number of UTI events per person months. These appear below under outcome measure data table.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
23 participants
Primary outcome timeframe
6 months prior to treatment and 6 months during treatment
Results posted on
2024-06-25
Participant Flow
Of 23 eligible persons who consented, only 19 started on treatment due to several reasons including changes in necessary study procedures associated with the COVID outbreak, changes in medical status due to complications and personal decisions to proceed with treatment.
Participant milestones
| Measure |
Gentamicin Sulfate
Participants initiate Gentamicin instillations every night for a period of 6 months. Instillations are stopped if they developed a UTI. After receiving treatment for the UTI and a one week washout period, they can resume their Gentamicin instillations. After screening, being consented and completing baseline interview, participants are instructed on how to do the instillations through a catheter, once they receive the drug and aid equipment (i.e. syringes) to do installations. Remaining drug in the syringe is to be disposed after each use. Participants use their own catheters. In-dwelling catheters are not allowed.
Gentamicin Sulfate: Gentamicin is compounded by the Michigan Medicine Research Pharmacy in a concentration of 480 milligrams of the active product to 1000 milliliters of normal saline. Participants will do daily instillations of 30 milliliters of solution
|
|---|---|
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Overall Study
STARTED
|
23
|
|
Overall Study
Began Treatment
|
19
|
|
Overall Study
Completed More Than 4 Months of Treatment
|
12
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Gentamicin Sulfate
Participants initiate Gentamicin instillations every night for a period of 6 months. Instillations are stopped if they developed a UTI. After receiving treatment for the UTI and a one week washout period, they can resume their Gentamicin instillations. After screening, being consented and completing baseline interview, participants are instructed on how to do the instillations through a catheter, once they receive the drug and aid equipment (i.e. syringes) to do installations. Remaining drug in the syringe is to be disposed after each use. Participants use their own catheters. In-dwelling catheters are not allowed.
Gentamicin Sulfate: Gentamicin is compounded by the Michigan Medicine Research Pharmacy in a concentration of 480 milligrams of the active product to 1000 milliliters of normal saline. Participants will do daily instillations of 30 milliliters of solution
|
|---|---|
|
Overall Study
First cohort faced a clinical hold which caused disruption in treatment;
|
4
|
|
Overall Study
Second cohort faced changes due to pandemic, resulting in declining participant count
|
2
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Gentamicin Bladder Instillations to Prevent Urinary Tract Infections in Patients With Spinal Cord Injury
Baseline characteristics by cohort
| Measure |
Gentamicin Sulfate
n=19 Participants
Participants initiate Gentamicin instillations every night for a period of 6 months. Instillations are stopped if they developed a UTI. After receiving treatment they can continue with the Gentamicin instillations. After baseline and consented they are instructed on how to do the instillations through a catheter, once they receive the drug and aid equipment (i.e. syringes) to do installations. Remaining drug is to be disposed after each use. Participants use their own catheters. In-dwelling catheters are not allowed.
Gentamicin Sulfate: Gentamicin will be compounded by the Michigan Medicine Research Pharmacy in a concentration of 480 milligrams of the active product to 1000 milliliters of normal saline. Participants will do daily instillations of 30 milliliters of solution
|
|---|---|
|
Age, Continuous
|
46 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=93 Participants
|
|
Type of spinal lesions
Spinal Cord Injury (SCI)
|
14 Participants
n=93 Participants
|
|
Type of spinal lesions
Spinal Cord Disease (SCD)
|
5 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 6 months prior to treatment and 6 months during treatmentPopulation: Eleven participants with spinal cord injury or disease and neurogenic bladder with recurrent urinary track infections (2 or more) during the 6 months prior to treatment.
Number of reported urinary tract infections (UTI) by participants and documented in medical chart, per person across months pre and post treatment. The number of UTIs over time was determined by establishing a per person-month rate made up of the total number of UTIs pre and during treatment (numerator) for the sample divided by the total number of persons/ 6 months (11 participants over 6 months period = 66) as the denominator. The unit of measure is defined as pre and during treatment number of UTI events per person months. These appear below under outcome measure data table.
Outcome measures
| Measure |
Gentamicin Sulfate
n=11 Participants
Participants initiate Gentamicin instillations every night for a period of 6 months. Instillations are stopped if they developed a UTI. After receiving treatment they can continue with the Gentamicin instillations. After baseline and consented they are instructed on how to do the instillations through a catheter, once they receive the drug and aid equipment (i.e. syringes) to do installations. Remaining drug is to be disposed after each use. Participants use their own catheters. In-dwelling catheters are not allowed.
Gentamicin Sulfate: Gentamicin will be compounded by the Michigan Medicine Research Pharmacy in a concentration of 480 milligrams of the active product to 1000 milliliters of normal saline. Participants will do daily instillations of 30 milliliters of solution
|
|---|---|
|
Number of Urinary Tract Infections (UTI) Over Time
6 months prior to treatment
|
0.53 UTI events per person months.
Interval 0.37 to 0.74
|
|
Number of Urinary Tract Infections (UTI) Over Time
6 months during treatment
|
0.09 UTI events per person months.
Interval 0.03 to 0.2
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SECONDARY outcome
Timeframe: Baseline to 6 monthsSelf-reported bladder symptoms on a scale from 0 (no symptoms) to 74 (maximum symptoms). The NBSS is a patient reported 22 item scale designed to assess symptoms and bladder related consequences among persons with neurogenic bladder dysfunction. NBSS scores are calculated across three domains with higher scores being worse and reflecting more symptoms or complications. Incontinence (scored 0-29), storage and voiding (scored 0-22), and consequences (scored 0-23). An additional question of happiness (points) was not used for this outcome.
Outcome measures
| Measure |
Gentamicin Sulfate
n=11 Participants
Participants initiate Gentamicin instillations every night for a period of 6 months. Instillations are stopped if they developed a UTI. After receiving treatment they can continue with the Gentamicin instillations. After baseline and consented they are instructed on how to do the instillations through a catheter, once they receive the drug and aid equipment (i.e. syringes) to do installations. Remaining drug is to be disposed after each use. Participants use their own catheters. In-dwelling catheters are not allowed.
Gentamicin Sulfate: Gentamicin will be compounded by the Michigan Medicine Research Pharmacy in a concentration of 480 milligrams of the active product to 1000 milliliters of normal saline. Participants will do daily instillations of 30 milliliters of solution
|
|---|---|
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Change in Score of Neurogenic Bladder Symptom Severity (NBSS) Scale
NBSS Incontinence (0-29)
|
-3.8 score on a scale
Interval -7.9 to 0.3
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|
Change in Score of Neurogenic Bladder Symptom Severity (NBSS) Scale
NBSS Storage/Void (0-22)
|
-1.1 score on a scale
Interval -3.8 to 1.7
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|
Change in Score of Neurogenic Bladder Symptom Severity (NBSS) Scale
NBSS Consequences (0-23)
|
-1.9 score on a scale
Interval -4.6 to 0.8
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SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: 11 participants with spinal cord injury or disease (SCI/D) with neurogenic bladder and recurrent UTIs during 6 months prior to treatment. They completed the NBD survey.
Self-reported bowel symptoms on a scale from 0 (very minor) to 14+ (severe). The NBD is a 10 item validated measure that assesses frequency of defecation and methods of bowel management and complications. Thus negative numbers in "score change" represent decrease in symptom severity.
Outcome measures
| Measure |
Gentamicin Sulfate
n=11 Participants
Participants initiate Gentamicin instillations every night for a period of 6 months. Instillations are stopped if they developed a UTI. After receiving treatment they can continue with the Gentamicin instillations. After baseline and consented they are instructed on how to do the instillations through a catheter, once they receive the drug and aid equipment (i.e. syringes) to do installations. Remaining drug is to be disposed after each use. Participants use their own catheters. In-dwelling catheters are not allowed.
Gentamicin Sulfate: Gentamicin will be compounded by the Michigan Medicine Research Pharmacy in a concentration of 480 milligrams of the active product to 1000 milliliters of normal saline. Participants will do daily instillations of 30 milliliters of solution
|
|---|---|
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Change in Score of Neurogenic Bowel Dysfunction (NBD)
|
-2.1 score on a scale
Interval -6.8 to 2.6
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Adverse Events
Gentamicin Sulfate
Serious events: 4 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gentamicin Sulfate
n=19 participants at risk
Participants initiate Gentamicin instillations every night for a period of 6 months. Instillations are stopped if they developed a UTI. After receiving treatment they can continue with the Gentamicin instillations. After baseline and consented they are instructed on how to do the instillations through a catheter, once they receive the drug and aid equipment (i.e. syringes) to do installations. Remaining drug is to be disposed after each use. Participants use their own catheters. In-dwelling catheters are not allowed.
Gentamicin Sulfate: Gentamicin will be compounded by the Michigan Medicine Research Pharmacy in a concentration of 480 milligrams of the active product to 1000 milliliters of normal saline. Participants will do daily instillations of 30 milliliters of solution
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|---|---|
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Renal and urinary disorders
Renal stone removal
|
5.3%
1/19 • Number of events 1 • AE data was gathered for 30 days after 6 months of treatment, a total of approximately 7 months.
|
|
Renal and urinary disorders
Gross hematuria
|
5.3%
1/19 • Number of events 1 • AE data was gathered for 30 days after 6 months of treatment, a total of approximately 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Post-COVID 19 pneumonia
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5.3%
1/19 • Number of events 1 • AE data was gathered for 30 days after 6 months of treatment, a total of approximately 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
5.3%
1/19 • Number of events 1 • AE data was gathered for 30 days after 6 months of treatment, a total of approximately 7 months.
|
|
Gastrointestinal disorders
bowel obstruction
|
5.3%
1/19 • Number of events 1 • AE data was gathered for 30 days after 6 months of treatment, a total of approximately 7 months.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
5.3%
1/19 • Number of events 2 • AE data was gathered for 30 days after 6 months of treatment, a total of approximately 7 months.
|
|
Skin and subcutaneous tissue disorders
Serratia tissue infection
|
5.3%
1/19 • Number of events 1 • AE data was gathered for 30 days after 6 months of treatment, a total of approximately 7 months.
|
Other adverse events
| Measure |
Gentamicin Sulfate
n=19 participants at risk
Participants initiate Gentamicin instillations every night for a period of 6 months. Instillations are stopped if they developed a UTI. After receiving treatment they can continue with the Gentamicin instillations. After baseline and consented they are instructed on how to do the instillations through a catheter, once they receive the drug and aid equipment (i.e. syringes) to do installations. Remaining drug is to be disposed after each use. Participants use their own catheters. In-dwelling catheters are not allowed.
Gentamicin Sulfate: Gentamicin will be compounded by the Michigan Medicine Research Pharmacy in a concentration of 480 milligrams of the active product to 1000 milliliters of normal saline. Participants will do daily instillations of 30 milliliters of solution
|
|---|---|
|
General disorders
Clinically significant labs
|
10.5%
2/19 • Number of events 2 • AE data was gathered for 30 days after 6 months of treatment, a total of approximately 7 months.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
63.2%
12/19 • Number of events 24 • AE data was gathered for 30 days after 6 months of treatment, a total of approximately 7 months.
|
|
Renal and urinary disorders
bladder spasms
|
15.8%
3/19 • Number of events 6 • AE data was gathered for 30 days after 6 months of treatment, a total of approximately 7 months.
|
|
Infections and infestations
COVID-19
|
21.1%
4/19 • Number of events 4 • AE data was gathered for 30 days after 6 months of treatment, a total of approximately 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
nasal discharge
|
5.3%
1/19 • Number of events 1 • AE data was gathered for 30 days after 6 months of treatment, a total of approximately 7 months.
|
|
Renal and urinary disorders
urinary discharge
|
5.3%
1/19 • Number of events 1 • AE data was gathered for 30 days after 6 months of treatment, a total of approximately 7 months.
|
|
Infections and infestations
abdominal stoma issue
|
10.5%
2/19 • Number of events 2 • AE data was gathered for 30 days after 6 months of treatment, a total of approximately 7 months.
|
|
Renal and urinary disorders
bladder irritation
|
5.3%
1/19 • Number of events 1 • AE data was gathered for 30 days after 6 months of treatment, a total of approximately 7 months.
|
|
General disorders
sweating
|
5.3%
1/19 • Number of events 1 • AE data was gathered for 30 days after 6 months of treatment, a total of approximately 7 months.
|
|
Skin and subcutaneous tissue disorders
heel wound
|
10.5%
2/19 • Number of events 2 • AE data was gathered for 30 days after 6 months of treatment, a total of approximately 7 months.
|
|
Renal and urinary disorders
air in bladder
|
5.3%
1/19 • Number of events 1 • AE data was gathered for 30 days after 6 months of treatment, a total of approximately 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
5.3%
1/19 • Number of events 1 • AE data was gathered for 30 days after 6 months of treatment, a total of approximately 7 months.
|
|
Renal and urinary disorders
bleeding from catheter site
|
5.3%
1/19 • Number of events 1 • AE data was gathered for 30 days after 6 months of treatment, a total of approximately 7 months.
|
|
Injury, poisoning and procedural complications
muscle strain
|
5.3%
1/19 • Number of events 1 • AE data was gathered for 30 days after 6 months of treatment, a total of approximately 7 months.
|
|
Infections and infestations
pneumonia
|
5.3%
1/19 • Number of events 1 • AE data was gathered for 30 days after 6 months of treatment, a total of approximately 7 months.
|
|
Infections and infestations
flu-like symptoms
|
15.8%
3/19 • Number of events 3 • AE data was gathered for 30 days after 6 months of treatment, a total of approximately 7 months.
|
|
Infections and infestations
bone infection
|
5.3%
1/19 • Number of events 1 • AE data was gathered for 30 days after 6 months of treatment, a total of approximately 7 months.
|
|
Renal and urinary disorders
hematuria
|
5.3%
1/19 • Number of events 1 • AE data was gathered for 30 days after 6 months of treatment, a total of approximately 7 months.
|
|
Renal and urinary disorders
bladder stone
|
5.3%
1/19 • Number of events 1 • AE data was gathered for 30 days after 6 months of treatment, a total of approximately 7 months.
|
|
Renal and urinary disorders
cystolitholapaxy
|
5.3%
1/19 • Number of events 1 • AE data was gathered for 30 days after 6 months of treatment, a total of approximately 7 months.
|
|
Gastrointestinal disorders
GI upset
|
10.5%
2/19 • Number of events 3 • AE data was gathered for 30 days after 6 months of treatment, a total of approximately 7 months.
|
|
Gastrointestinal disorders
loose stool
|
5.3%
1/19 • Number of events 1 • AE data was gathered for 30 days after 6 months of treatment, a total of approximately 7 months.
|
|
Infections and infestations
conjunctivitis
|
5.3%
1/19 • Number of events 1 • AE data was gathered for 30 days after 6 months of treatment, a total of approximately 7 months.
|
|
Infections and infestations
parotitis
|
5.3%
1/19 • Number of events 1 • AE data was gathered for 30 days after 6 months of treatment, a total of approximately 7 months.
|
|
Infections and infestations
vaginitis
|
5.3%
1/19 • Number of events 1 • AE data was gathered for 30 days after 6 months of treatment, a total of approximately 7 months.
|
|
Injury, poisoning and procedural complications
inguinal pain
|
5.3%
1/19 • Number of events 1 • AE data was gathered for 30 days after 6 months of treatment, a total of approximately 7 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place