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Study of a Urethral Catheter Coated With Eluting Silver Salts (SUCCESS) (SUCCESS)

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ClinicalTrials.gov Identifier: NCT00482547
Recruitment Status : Terminated (Terminated for futility reasons.)
First Posted : June 5, 2007
Results First Posted : January 21, 2010
Last Update Posted : February 28, 2017
Sponsor:
Information provided by (Responsible Party):
C. R. Bard

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Catheterization
Interventions Device: Hydrogel Silver Salts Coated Latex Urinary Catheter System
Device: Bard silicone elastomer coated latex catheter system
Enrollment 1188
Recruitment Details Twenty Investigators at 20 Investigative Sites enrolled a total of 1188 study subjects between June 28, 2007 and June 23, 2008.
Pre-assignment Details 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.
Arm/Group Title Silver-coated Catheter Silicone-coated Catheter
Hide Arm/Group Description Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter silicone elastomer-coated latex catheter
Period Title: Overall Study
Started 599 [1] 589 [2]
Successful Catheterization 565 [3] 568 [4]
48 Hour Evaluation 426 [5] 428 [6]
Completed 426 428
Not Completed 173 161
[1]
599 subjects were enrolled in the silver-coated catheter group.
[2]
589 subjects were enrolled in the silicone-coated catheter group.
[3]
Out of the 599 AgCS subjects 565 (94.3%) had a successful catheterization.
[4]
Out of the 589 SiCS catheter subjects 568 (96.4%) had a successful catheterization.
[5]
426 went on to be included in the Silver-coated 48 hour efficacy evaluable population.
[6]
428 went on to be included in the Silicone-coated 48 hour efficacy evaluable population.
Arm/Group Title Silver-coated Catheter Silicone-coated Catheter Total
Hide Arm/Group Description Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter silicone elastomer-coated latex catheter Total of all reporting groups
Overall Number of Baseline Participants 599 589 1188
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 599 participants 589 participants 1188 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
302
  50.4%
287
  48.7%
589
  49.6%
>=65 years
297
  49.6%
302
  51.3%
599
  50.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 599 participants 589 participants 1188 participants
63.7  (15.9) 64.3  (14.5) 64.0  (15.2)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 599 participants 589 participants 1188 participants
Female
341
  56.9%
332
  56.4%
673
  56.6%
Male
258
  43.1%
257
  43.6%
515
  43.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 599 participants 589 participants 1188 participants
599 589 1188
1.Primary Outcome
Title Time to Occurrence of Bacteriuric Urinary Tract Infection (bUTI) in Subjects Catheterized for >= 48 Hours
Hide Description 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.
Time Frame >=48 hours to 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Silver-coated Catheter Silicone-coated Catheter
Hide Arm/Group Description:
Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
silicone elastomer-coated latex catheter
Overall Number of Participants Analyzed 57 76
Median (Standard Deviation)
Unit of Measure: Days
2.10  (1.99) 2.06  (2.32)
2.Secondary Outcome
Title Percentage of Participants With a bUTI After Catheterization for >= 48 Hours
Hide Description 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.
Time Frame >=48 hours to 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Silver-coated Catheter Silicone-coated Catheter
Hide Arm/Group Description:
Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
silicone elastomer-coated latex catheter
Overall Number of Participants Analyzed 426 428
Measure Type: Number
Unit of Measure: Percentage of Participants with a bUTI
13.4 17.8
3.Secondary Outcome
Title Time to Occurence of Symptomatic Urinary Tract Infection (sUTI) in Subjects Catheterized for >= 48 Hours
Hide Description 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.
Time Frame >= 48 hours to 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable (48) population: ITT subjects who were catheterized with a study catheter for ≥ 48 hours and who developed a sUTI after catheter insertion.
Arm/Group Title Silver-coated Catheter Silicone-coated Catheter
Hide Arm/Group Description:
Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
silicone elastomer-coated latex catheter
Overall Number of Participants Analyzed 37 38
Median (Standard Deviation)
Unit of Measure: Days
1.23  (1.75) 1.62  (1.48)
4.Secondary Outcome
Title Time to Occurence of bUTI in Subjects Catheterized for >= 24 Hours
Hide Description 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.
Time Frame >= 24 hours to 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable (24) population: ITT subjects who were catheterized with a study catheter for ≥ 24 hours and who developed a bUTI after catheter insertion.
Arm/Group Title Silver-coated Catheter Silicone-coated Catheter
Hide Arm/Group Description:
Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
silicone elastomer-coated latex catheter
Overall Number of Participants Analyzed 61 78
Median (Standard Deviation)
Unit of Measure: Days
2.03  (1.98) 2.04  (2.31)
5.Secondary Outcome
Title Time to Occurance of sUTI in Subjects Catheterized for >= 24 Hours
Hide Description 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.
Time Frame >= 24 hours to 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable (24) population: ITT subjects who were catheterized with a study catheter for ≥ 24 hours and who developed a bUTI after catheter insertion.
Arm/Group Title Silver-coated Catheter Silicone-coated Catheter
Hide Arm/Group Description:
Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
silicone elastomer-coated latex catheter
Overall Number of Participants Analyzed 39 39
Median (Standard Deviation)
Unit of Measure: Days
1.1039  (1.73) 1.40  (1.47)
6.Secondary Outcome
Title Number of Participants With Bacteriuria at a Concentration of ≥ 10e3 < 10e5 CFU/mL
Hide Description The number of subjects with bacteriuria levels ≥ 10e3 < 10e5 CFU/mL who subsequently developed a bUTI or a sUTI
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: ITT subjects who were catheterized with a study catheter. This population was used to assess tolerability and safety endpoints.
Arm/Group Title Silver-coated Catheter Silicone-coated Catheter
Hide Arm/Group Description:
Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
silicone elastomer-coated latex catheter
Overall Number of Participants Analyzed 565 568
Measure Type: Number
Unit of Measure: Participants
38 35
7.Other Pre-specified Outcome
Title Number of Subjects With a bUTI Catheterized for >=48 Hours.
Hide Description 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.
Time Frame From time of catheterization until 10 days post catheterization or 48 hours after catheter removal.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Silver-coated Catheter Silicone-coated Catheter
Hide Arm/Group Description:
Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
silicone elastomer-coated latex catheter
Overall Number of Participants Analyzed 426 428
Measure Type: Number
Unit of Measure: Participants
57 76
8.Other Pre-specified Outcome
Title Number of Subjects With a sUTI Catheterized for >=48 Hours.
Hide Description 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.
Time Frame From time of catheterization until 10 days or 48 hours after catheter was removed
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Silver-coated Catheter Silicone-coated Catheter
Hide Arm/Group Description:
Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
silicone elastomer-coated latex catheter
Overall Number of Participants Analyzed 426 428
Measure Type: Number
Unit of Measure: Participants
37 38
Time Frame 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.
Adverse Event Reporting Description

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.

 
Arm/Group Title Silver-coated Catheter Silicone-coated Catheter
Hide Arm/Group Description Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter silicone elastomer-coated latex catheter
All-Cause Mortality
Silver-coated Catheter Silicone-coated Catheter
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Silver-coated Catheter Silicone-coated Catheter
Affected / at Risk (%) Affected / at Risk (%)
Total   47/565 (8.32%)   58/568 (10.21%) 
Blood and lymphatic system disorders     
Anemia * 1  4/565 (0.71%)  4/568 (0.70%) 
Thrombocytopenia * 1  1/565 (0.18%)  0/568 (0.00%) 
Cardiac disorders     
Atrial Fibrillation * 1  2/565 (0.35%)  4/568 (0.70%) 
Cardiac Arrest * 1  1/565 (0.18%)  3/568 (0.53%) 
Ventricular Tachycardia * 1  2/565 (0.35%)  2/568 (0.35%) 
Cardiac Failure Congestive * 1  1/565 (0.18%)  1/568 (0.18%) 
Myocardial Infarction * 1  1/565 (0.18%)  1/568 (0.18%) 
Supraventricular Tachycardia * 1  2/565 (0.35%)  0/568 (0.00%) 
Angina Pectoris * 1  0/565 (0.00%)  1/568 (0.18%) 
Bradycardia * 1  0/565 (0.00%)  1/568 (0.18%) 
Cardiac Tamponade * 1  1/565 (0.18%)  0/568 (0.00%) 
Cardio-Respiratory Arrest * 1  1/565 (0.18%)  0/568 (0.00%) 
Right Ventricular Failure * 1  1/565 (0.18%)  0/568 (0.00%) 
Sinus Tachycardia * 1  1/565 (0.18%)  0/568 (0.00%) 
Ventricular Fibrillation * 1  0/565 (0.00%)  1/568 (0.18%) 
Gastrointestinal disorders     
Abdominal Distension * 1  0/565 (0.00%)  1/568 (0.18%) 
Constipation * 1  1/565 (0.18%)  0/568 (0.00%) 
Enterocutaneous Fistula * 1  1/565 (0.18%)  0/568 (0.00%) 
Ileus * 1  1/565 (0.18%)  0/568 (0.00%) 
Nausea * 1  1/565 (0.18%)  0/568 (0.00%) 
Retroperitoneal Haematoma * 1  1/565 (0.18%)  0/568 (0.00%) 
Small Intestinal Obstruction * 1  1/565 (0.18%)  0/568 (0.00%) 
General disorders     
Chest Pain * 1  0/565 (0.00%)  1/568 (0.18%) 
Multi-Organ Failure * 1  0/565 (0.00%)  1/568 (0.18%) 
Hepatobiliary disorders     
Hepatic Failure * 1  0/565 (0.00%)  1/568 (0.18%) 
Infections and infestations     
Sepsis * 1  2/565 (0.35%)  3/568 (0.53%) 
Septic Shock * 1  2/565 (0.35%)  1/568 (0.18%) 
Bronchitis * 1  0/565 (0.00%)  1/568 (0.18%) 
Injury, poisoning and procedural complications     
Postoperative Ileus * 1  1/565 (0.18%)  2/568 (0.35%) 
Abdominal Wound Dehiscence * 1  1/565 (0.18%)  1/568 (0.18%) 
Anastomotic Leak * 1  1/565 (0.18%)  1/568 (0.18%) 
Reocclusion * 1  1/565 (0.18%)  0/568 (0.00%) 
Wound Dehiscence * 1  1/565 (0.18%)  0/568 (0.00%) 
Investigations     
Blood Amylase Increased * 1  1/565 (0.18%)  0/568 (0.00%) 
Blood Creatine Increased * 1  1/565 (0.18%)  0/568 (0.00%) 
Lipase Increased * 1  1/565 (0.18%)  0/568 (0.00%) 
Metabolism and nutrition disorders     
Hypokalaemia * 1  1/565 (0.18%)  0/568 (0.00%) 
Lactic Acidosis * 1  0/565 (0.00%)  1/568 (0.18%) 
Musculoskeletal and connective tissue disorders     
Mobility Decreased * 1  1/565 (0.18%)  0/568 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute Myeloid Leukaemia * 1  1/565 (0.18%)  0/568 (0.00%) 
Nervous system disorders     
Cerebrovascular Accident * 1  1/565 (0.18%)  1/568 (0.18%) 
Cerebellar Haemorrhage * 1  1/565 (0.18%)  0/568 (0.00%) 
Encephalopathy * 1  0/565 (0.00%)  1/568 (0.18%) 
Syncope Vasovagal * 1  1/565 (0.18%)  0/568 (0.00%) 
Psychiatric disorders     
Mental Status Changes * 1  1/565 (0.18%)  1/568 (0.18%) 
Alcohol Withdrawal Syndrome * 1  1/565 (0.18%)  0/568 (0.00%) 
Renal and urinary disorders     
Renal Failure * 1  1/565 (0.18%)  1/568 (0.18%) 
Renal Failure Acute * 1  1/565 (0.18%)  1/568 (0.18%) 
Acute Prerenal Failure * 1  0/565 (0.00%)  1/568 (0.18%) 
Haematuria * 1  1/565 (0.18%)  0/568 (0.00%) 
Renal Tubular Necrosis * 1  0/565 (0.00%)  1/568 (0.18%) 
Urinary Retention * 1  1/565 (0.18%)  0/568 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory Failure * 1  7/565 (1.24%)  14/568 (2.46%) 
Respiratory Distress * 1  2/565 (0.35%)  1/568 (0.18%) 
Acute Respiratory Failure * 1  0/565 (0.00%)  1/568 (0.18%) 
Aspiration * 1  1/565 (0.18%)  0/568 (0.00%) 
Atelectasis * 1  0/565 (0.00%)  1/568 (0.18%) 
Chylothorax * 1  0/565 (0.00%)  1/568 (0.18%) 
Increased Bronchial Secretion * 1  0/565 (0.00%)  1/568 (0.18%) 
Interstitial Lung Disease * 1  0/565 (0.00%)  1/568 (0.18%) 
Obstructive Airways Disorder * 1  0/565 (0.00%)  1/568 (0.18%) 
Pneumothorax * 1  0/565 (0.00%)  1/568 (0.18%) 
Tachypnoea * 1  0/565 (0.00%)  1/568 (0.18%) 
Skin and subcutaneous tissue disorders     
Angioedema * 1  1/565 (0.18%)  0/568 (0.00%) 
Surgical and medical procedures     
Wound Drainage * 1  0/565 (0.00%)  1/568 (0.18%) 
Vascular disorders     
Hypotension * 1  2/565 (0.35%)  1/568 (0.18%) 
Hypertension * 1  2/565 (0.35%)  0/568 (0.00%) 
Haemorrhage * 1  0/565 (0.00%)  1/568 (0.18%) 
Shock * 1  1/565 (0.18%)  0/568 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1.0%
Silver-coated Catheter Silicone-coated Catheter
Affected / at Risk (%) Affected / at Risk (%)
Total   15/565 (2.65%)   29/568 (5.11%) 
Renal and urinary disorders     
Haematuria * 1  12/565 (2.12%)  15/568 (2.64%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory Failure * 1  7/565 (1.24%)  14/568 (2.46%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Sample size calculations required 1244 Efficacy Evaluable 48 subjects, only 854 Efficacy Evaluable 48 subjects were enrolled, which does not allow for a fully powered study and there is the threat of a type II error (false negative result).
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vanessa Dell Clinical Research Scientist
Organization: C. R. Bard
Phone: 908-277-8094
EMail: vanessa.dell@crbard.com
Layout table for additonal information
Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT00482547     History of Changes
Other Study ID Numbers: BMD-6003
First Submitted: June 4, 2007
First Posted: June 5, 2007
Results First Submitted: April 6, 2009
Results First Posted: January 21, 2010
Last Update Posted: February 28, 2017