Trial Outcomes & Findings for Study of a Urethral Catheter Coated With Eluting Silver Salts (SUCCESS) (NCT NCT00482547)
NCT ID: NCT00482547
Last Updated: 2017-02-28
Results Overview
Time to occurrence of bUTI in subjects of both study groups who were catheterized with a study catheter for \>= 48 hours and who had evidence of bUTI after study catheter insertion. Subjects who did not have a bUTI are not included in the median calculation, so the median only includes data from non-censored observations.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
1188 participants
Primary outcome timeframe
>=48 hours to 10 days
Results posted on
2017-02-28
Participant Flow
Twenty Investigators at 20 Investigative Sites enrolled a total of 1188 study subjects between June 28, 2007 and June 23, 2008.
Subjects judged by site personnel to require a urinary catheter for at least 48-72 hours were screened against the study inclusion/exclusion criteria. Those subjects meeting these criteria were offered participation in the study.
Participant milestones
| Measure |
Silver-coated Catheter
Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
|
Silicone-coated Catheter
silicone elastomer-coated latex catheter
|
|---|---|---|
|
Overall Study
STARTED
|
599
|
589
|
|
Overall Study
Successful Catheterization
|
565
|
568
|
|
Overall Study
48 Hour Evaluation
|
426
|
428
|
|
Overall Study
COMPLETED
|
426
|
428
|
|
Overall Study
NOT COMPLETED
|
173
|
161
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of a Urethral Catheter Coated With Eluting Silver Salts (SUCCESS)
Baseline characteristics by cohort
| Measure |
Silver-coated Catheter
n=599 Participants
Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
|
Silicone-coated Catheter
n=589 Participants
silicone elastomer-coated latex catheter
|
Total
n=1188 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
302 Participants
n=5 Participants
|
287 Participants
n=7 Participants
|
589 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
297 Participants
n=5 Participants
|
302 Participants
n=7 Participants
|
599 Participants
n=5 Participants
|
|
Age, Continuous
|
63.7 years
STANDARD_DEVIATION 15.9 • n=5 Participants
|
64.3 years
STANDARD_DEVIATION 14.5 • n=7 Participants
|
64.0 years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
|
Gender
Female
|
341 Participants
n=5 Participants
|
332 Participants
n=7 Participants
|
673 Participants
n=5 Participants
|
|
Gender
Male
|
258 Participants
n=5 Participants
|
257 Participants
n=7 Participants
|
515 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
599 participants
n=5 Participants
|
589 participants
n=7 Participants
|
1188.0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: >=48 hours to 10 daysPopulation: Efficacy Evaluable (48) population: Intent-to-treat (ITT) subjects who were catheterized with a study catheter for ≥ 48 hours and who developed a bUTI after catheter insertion.
Time to occurrence of bUTI in subjects of both study groups who were catheterized with a study catheter for \>= 48 hours and who had evidence of bUTI after study catheter insertion. Subjects who did not have a bUTI are not included in the median calculation, so the median only includes data from non-censored observations.
Outcome measures
| Measure |
Silver-coated Catheter
n=57 Participants
Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
|
Silicone-coated Catheter
n=76 Participants
silicone elastomer-coated latex catheter
|
|---|---|---|
|
Time to Occurrence of Bacteriuric Urinary Tract Infection (bUTI) in Subjects Catheterized for >= 48 Hours
|
2.10 Days
Standard Deviation 1.99
|
2.06 Days
Standard Deviation 2.32
|
SECONDARY outcome
Timeframe: >=48 hours to 10 daysPopulation: Efficacy Evaluable (48) population: ITT subjects who were catheterized with a study catheter for ≥ 48 hours and who did not have a bUTI in the baseline urine sample obtained at the time of catheter insertion.
The percentage of bUTI was calculated as the rate of new occurrence of bUTI in subjects of both study groups who had been catheterized with a study catheter for \>= 48 hours and who did not have evidence of bUTI at the time of study catheter insertion.
Outcome measures
| Measure |
Silver-coated Catheter
n=426 Participants
Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
|
Silicone-coated Catheter
n=428 Participants
silicone elastomer-coated latex catheter
|
|---|---|---|
|
Percentage of Participants With a bUTI After Catheterization for >= 48 Hours
|
13.4 Percentage of Participants with a bUTI
|
17.8 Percentage of Participants with a bUTI
|
SECONDARY outcome
Timeframe: >= 48 hours to 10 daysPopulation: Efficacy Evaluable (48) population: ITT subjects who were catheterized with a study catheter for ≥ 48 hours and who developed a sUTI after catheter insertion.
The time to occurrence of sUTI was measured as the time between catheter insertion and when the criteria for sUTI was met, up to 10 days after catheterization plus 48 hours after catheter removal. Subjects who did not have a sUTI are not included in the median calculation, so the median only includes data from non-censored observations.
Outcome measures
| Measure |
Silver-coated Catheter
n=37 Participants
Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
|
Silicone-coated Catheter
n=38 Participants
silicone elastomer-coated latex catheter
|
|---|---|---|
|
Time to Occurence of Symptomatic Urinary Tract Infection (sUTI) in Subjects Catheterized for >= 48 Hours
|
1.23 Days
Standard Deviation 1.75
|
1.62 Days
Standard Deviation 1.48
|
SECONDARY outcome
Timeframe: >= 24 hours to 10 daysPopulation: Efficacy Evaluable (24) population: ITT subjects who were catheterized with a study catheter for ≥ 24 hours and who developed a bUTI after catheter insertion.
Time to occurrence of bUTI in subjects of both study groups who were catheterized with a study catheter for \>= 24 hours and developed a bUTI at after catheter insertion. Subjects who did not have a bUTI are not included in the median calculation, so the median only includes data from non-censored observations.
Outcome measures
| Measure |
Silver-coated Catheter
n=61 Participants
Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
|
Silicone-coated Catheter
n=78 Participants
silicone elastomer-coated latex catheter
|
|---|---|---|
|
Time to Occurence of bUTI in Subjects Catheterized for >= 24 Hours
|
2.03 Days
Standard Deviation 1.98
|
2.04 Days
Standard Deviation 2.31
|
SECONDARY outcome
Timeframe: >= 24 hours to 10 daysPopulation: Efficacy Evaluable (24) population: ITT subjects who were catheterized with a study catheter for ≥ 24 hours and who developed a bUTI after catheter insertion.
The time to occurrence of sUTI was measured as the time between catheter insertion and when the criteria for sUTI was met, up to 10 days after catheterization plus 48 hours after catheter removal. Subjects who did not have a sUTI are not included in the median calculation, so the median only includes data from non-censored observations.
Outcome measures
| Measure |
Silver-coated Catheter
n=39 Participants
Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
|
Silicone-coated Catheter
n=39 Participants
silicone elastomer-coated latex catheter
|
|---|---|---|
|
Time to Occurance of sUTI in Subjects Catheterized for >= 24 Hours
|
1.1039 Days
Standard Deviation 1.73
|
1.40 Days
Standard Deviation 1.47
|
SECONDARY outcome
Timeframe: 10 daysPopulation: Safety population: ITT subjects who were catheterized with a study catheter. This population was used to assess tolerability and safety endpoints.
The number of subjects with bacteriuria levels ≥ 10e3 \< 10e5 CFU/mL who subsequently developed a bUTI or a sUTI
Outcome measures
| Measure |
Silver-coated Catheter
n=565 Participants
Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
|
Silicone-coated Catheter
n=568 Participants
silicone elastomer-coated latex catheter
|
|---|---|---|
|
Number of Participants With Bacteriuria at a Concentration of ≥ 10e3 < 10e5 CFU/mL
|
38 Participants
|
35 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From time of catheterization until 10 days post catheterization or 48 hours after catheter removal.Population: Efficacy Evaluable (48) population: ITT subjects who were catheterized with a study catheter for ≥ 48 hours and who did not have a bUTI in the baseline urine sample obtained at the time of catheter insertion.
bUTI occurences were counted in subjects of both study groups who had been catheterized with a study catheter for \>= 48 hours and who did not have evidence of bUTI at the time of study catheter insertion.
Outcome measures
| Measure |
Silver-coated Catheter
n=426 Participants
Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
|
Silicone-coated Catheter
n=428 Participants
silicone elastomer-coated latex catheter
|
|---|---|---|
|
Number of Subjects With a bUTI Catheterized for >=48 Hours.
|
57 Participants
|
76 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From time of catheterization until 10 days or 48 hours after catheter was removedPopulation: Efficacy Evaluable (48) population: ITT subjects who were catheterized with a study catheter for ≥ 48 hours and who did not have a bUTI in the baseline urine sample obtained at the time of catheter insertion.
sUTI occurences were counted in subjects of both study groups who had been catheterized with a study catheter for \>= 48 hours and who did not have evidence of bUTI at the time of study catheter insertion.
Outcome measures
| Measure |
Silver-coated Catheter
n=426 Participants
Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
|
Silicone-coated Catheter
n=428 Participants
silicone elastomer-coated latex catheter
|
|---|---|---|
|
Number of Subjects With a sUTI Catheterized for >=48 Hours.
|
37 Participants
|
38 Participants
|
Adverse Events
Silver-coated Catheter
Serious events: 47 serious events
Other events: 15 other events
Deaths: 0 deaths
Silicone-coated Catheter
Serious events: 58 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Silver-coated Catheter
n=565 participants at risk
Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
|
Silicone-coated Catheter
n=568 participants at risk
silicone elastomer-coated latex catheter
|
|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.18%
1/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.2%
7/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
2.5%
14/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.35%
2/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.18%
1/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.18%
1/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.18%
1/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.00%
0/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.18%
1/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.00%
0/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.18%
1/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Respiratory, thoracic and mediastinal disorders
Increased Bronchial Secretion
|
0.00%
0/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.18%
1/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.00%
0/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.18%
1/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive Airways Disorder
|
0.00%
0/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.18%
1/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.18%
1/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.18%
1/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.35%
2/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.70%
4/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Cardiac disorders
Cardiac Arrest
|
0.18%
1/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.53%
3/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.35%
2/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.35%
2/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.18%
1/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.18%
1/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Cardiac disorders
Myocardial Infarction
|
0.18%
1/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.18%
1/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.35%
2/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.00%
0/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.18%
1/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Cardiac disorders
Cardiac Tamponade
|
0.18%
1/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.00%
0/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.18%
1/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.00%
0/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Cardiac disorders
Right Ventricular Failure
|
0.18%
1/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.00%
0/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Cardiac disorders
Sinus Tachycardia
|
0.18%
1/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.00%
0/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.00%
0/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.18%
1/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Blood and lymphatic system disorders
Anemia
|
0.71%
4/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.70%
4/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.18%
1/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.00%
0/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Infections and infestations
Sepsis
|
0.35%
2/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.53%
3/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Infections and infestations
Septic Shock
|
0.35%
2/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.18%
1/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.18%
1/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Injury, poisoning and procedural complications
Postoperative Ileus
|
0.18%
1/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.35%
2/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Injury, poisoning and procedural complications
Abdominal Wound Dehiscence
|
0.18%
1/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.18%
1/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Injury, poisoning and procedural complications
Anastomotic Leak
|
0.18%
1/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.18%
1/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Injury, poisoning and procedural complications
Reocclusion
|
0.18%
1/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.00%
0/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.18%
1/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.00%
0/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.18%
1/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Gastrointestinal disorders
Constipation
|
0.18%
1/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.00%
0/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Gastrointestinal disorders
Enterocutaneous Fistula
|
0.18%
1/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.00%
0/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Gastrointestinal disorders
Ileus
|
0.18%
1/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.00%
0/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Gastrointestinal disorders
Nausea
|
0.18%
1/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.00%
0/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Gastrointestinal disorders
Retroperitoneal Haematoma
|
0.18%
1/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.00%
0/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.18%
1/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.00%
0/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Renal and urinary disorders
Renal Failure
|
0.18%
1/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.18%
1/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.18%
1/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.18%
1/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Renal and urinary disorders
Acute Prerenal Failure
|
0.00%
0/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.18%
1/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Renal and urinary disorders
Haematuria
|
0.18%
1/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.00%
0/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Renal and urinary disorders
Renal Tubular Necrosis
|
0.00%
0/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.18%
1/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Renal and urinary disorders
Urinary Retention
|
0.18%
1/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.00%
0/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Vascular disorders
Hypotension
|
0.35%
2/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.18%
1/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Vascular disorders
Hypertension
|
0.35%
2/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.00%
0/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.18%
1/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Vascular disorders
Shock
|
0.18%
1/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.00%
0/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.18%
1/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.18%
1/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Nervous system disorders
Cerebellar Haemorrhage
|
0.18%
1/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.00%
0/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.18%
1/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Nervous system disorders
Syncope Vasovagal
|
0.18%
1/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.00%
0/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Psychiatric disorders
Mental Status Changes
|
0.18%
1/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.18%
1/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Psychiatric disorders
Alcohol Withdrawal Syndrome
|
0.18%
1/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.00%
0/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
General disorders
Chest Pain
|
0.00%
0/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.18%
1/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
General disorders
Multi-Organ Failure
|
0.00%
0/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.18%
1/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Investigations
Blood Amylase Increased
|
0.18%
1/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.00%
0/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Investigations
Blood Creatine Increased
|
0.18%
1/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.00%
0/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Investigations
Lipase Increased
|
0.18%
1/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.00%
0/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.18%
1/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.00%
0/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Metabolism and nutrition disorders
Lactic Acidosis
|
0.00%
0/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.18%
1/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.00%
0/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.18%
1/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Musculoskeletal and connective tissue disorders
Mobility Decreased
|
0.18%
1/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.00%
0/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukaemia
|
0.18%
1/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.00%
0/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.18%
1/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.00%
0/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Surgical and medical procedures
Wound Drainage
|
0.00%
0/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
0.18%
1/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
Other adverse events
| Measure |
Silver-coated Catheter
n=565 participants at risk
Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
|
Silicone-coated Catheter
n=568 participants at risk
silicone elastomer-coated latex catheter
|
|---|---|---|
|
Renal and urinary disorders
Haematuria
|
2.1%
12/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
2.6%
15/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.2%
7/565 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
2.5%
14/568 • Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection. All SAEs were collected, as defined in 21 CFR 803.3.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60