Trial Outcomes & Findings for Reduction of Bacteriuria in Subjects Practicing Intermittent Catheterization (NCT NCT01143116)

Results Overview

Change from baseline (urine sample immediately before first catheterization with study product) and after 24 hours of intermittent catheterization with the randomised study catheter.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Baseline and after 24 hours

Results posted on

2022-05-03

Participant Flow

Participant milestones

Participant milestones
Measure	Catheter A Silver-nitrate coated catheter ("Catheter A"): Catheter A releases silver ions into the urethra and urinary bladder upon catheterization.	Catheter B Degradable silver particle-coated catheter ("Catheter B"): Catheter B releases both silver ions and degradable silver particles into the urethra and urinary bladder upon catheterization.
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reduction of Bacteriuria in Subjects Practicing Intermittent Catheterization

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Catheter A n=10 Participants Silver-nitrate coated catheter ("Catheter A"): Catheter A releases silver ions into the urethra and urinary bladder upon catheterization.	Catheter B n=10 Participants Degradable silver particle-coated catheter ("Catheter B"): Catheter B releases both silver ions and degradable silver particles into the urethra and urinary bladder upon catheterization.	Total n=20 Participants Total of all reporting groups
Age, Continuous	49 years STANDARD_DEVIATION 8 • n=5 Participants	40 years STANDARD_DEVIATION 8 • n=7 Participants	44 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment Sweden	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and after 24 hours

Population: ITT

Change from baseline (urine sample immediately before first catheterization with study product) and after 24 hours of intermittent catheterization with the randomised study catheter.

Outcome measures

Outcome measures
Measure	Catheter A n=10 Participants Silver-nitrate coated catheter ("Catheter A"): Catheter A releases silver ions into the urethra and urinary bladder upon catheterization.	Catheter B n=10 Participants Degradable silver particle-coated catheter ("Catheter B"): Catheter B releases both silver ions and degradable silver particles into the urethra and urinary bladder upon catheterization.
Total Bacteria Count Change From Baseline and After 24 Hours.	-62519 CFU/mL Standard Deviation 9710767	57448 CFU/mL Standard Deviation 9810360

PRIMARY outcome

Timeframe: Baseline and after 48 hours

Population: ITT

Change from baseline (urine sample immediately before first catheterization with study product) and after 48 hours of intermittent catheterization. After the baseline sample the subject had 24 hours with study randomized catheter and then changed to 24 hours on non-study sterile intermittent catheterization.

Outcome measures

Outcome measures
Measure	Catheter A n=10 Participants Silver-nitrate coated catheter ("Catheter A"): Catheter A releases silver ions into the urethra and urinary bladder upon catheterization.	Catheter B n=10 Participants Degradable silver particle-coated catheter ("Catheter B"): Catheter B releases both silver ions and degradable silver particles into the urethra and urinary bladder upon catheterization.
Total Bacteria Count Change From Baseline and After 48 Hours.	-1980704 CFU/mL Standard Deviation 6599515	2072657 CFU/mL Standard Deviation 11673736

PRIMARY outcome

Timeframe: Baseline and after 7-14 days

Population: ITT

Change from baseline and after 7-14 days. Change from baseline (urine sample immediately before first catheterization with study product) to after 7-14 days.

Outcome measures

Outcome measures
Measure	Catheter A n=10 Participants Silver-nitrate coated catheter ("Catheter A"): Catheter A releases silver ions into the urethra and urinary bladder upon catheterization.	Catheter B n=10 Participants Degradable silver particle-coated catheter ("Catheter B"): Catheter B releases both silver ions and degradable silver particles into the urethra and urinary bladder upon catheterization.
Total Bacteria Count Change From Baseline and After 7-14 Days.	12477797 CFU/mL Standard Deviation 10769480	18650000 CFU/mL Standard Deviation 6851389

SECONDARY outcome

Timeframe: After first catheterization with study product and after 12 hours

Population: Subjects with positive values

Escherichia coli mean bacteria count change from baseline (subjects with positive values) to after 12 hours. Baseline (urine sample immediately before first catheterization with study product) and then at 12 hours of study catheter use.

Outcome measures

Outcome measures
Measure	Catheter A n=4 Participants Silver-nitrate coated catheter ("Catheter A"): Catheter A releases silver ions into the urethra and urinary bladder upon catheterization.	Catheter B n=5 Participants Degradable silver particle-coated catheter ("Catheter B"): Catheter B releases both silver ions and degradable silver particles into the urethra and urinary bladder upon catheterization.
Escherichia Coli Mean Bacteria Count Change From Baseline to 12 Hours	0 CFU/mL Standard Deviation 0	74500 CFU/mL Standard Deviation 166587

SECONDARY outcome

Timeframe: After first catheterization with study product and after 24 hours

Population: Subjects with positive values

Escherichia coli mean bacteria count change from baseline (subjects with positive values). Baseline (urine sample immediately before first catheterization with study product) and then at 24 hours of study catheter use.

Outcome measures

Outcome measures
Measure	Catheter A n=4 Participants Silver-nitrate coated catheter ("Catheter A"): Catheter A releases silver ions into the urethra and urinary bladder upon catheterization.	Catheter B n=5 Participants Degradable silver particle-coated catheter ("Catheter B"): Catheter B releases both silver ions and degradable silver particles into the urethra and urinary bladder upon catheterization.
Escherichia Coli Mean Bacteria Count Change From Baseline to 24 Hours	5113750 CFU/mL Standard Deviation 10227500	-4124000 CFU/mL Standard Deviation 9221544

SECONDARY outcome

Timeframe: After first catheterization with study product and after 12 hours

Population: Subjects with positive values

Enterococcus faecalis mean bacteria count change from baseline (subjects with positive values). Baseline (urine sample immediately before first catheterization with study product) and then at 12 hours of study catheter use.

Outcome measures

Outcome measures
Measure	Catheter A n=2 Participants Silver-nitrate coated catheter ("Catheter A"): Catheter A releases silver ions into the urethra and urinary bladder upon catheterization.	Catheter B n=1 Participants Degradable silver particle-coated catheter ("Catheter B"): Catheter B releases both silver ions and degradable silver particles into the urethra and urinary bladder upon catheterization.
Enterococcus Faecalis Mean Bacteria Count Change From Baseline to 12 Hours	333 CFU/mL Standard Deviation 612	20997300 CFU/mL

SECONDARY outcome

Timeframe: After first catheterization with study product and after 24 hours

Population: Subjects with positive values

Enterococcus faecalis mean bacteria count change from baseline (subjects with positive values). Baseline (urine sample immediately before first catheterization with study product) and then at 24 hours of study catheter use.

Outcome measures

Outcome measures
Measure	Catheter A n=2 Participants Silver-nitrate coated catheter ("Catheter A"): Catheter A releases silver ions into the urethra and urinary bladder upon catheterization.	Catheter B n=1 Participants Degradable silver particle-coated catheter ("Catheter B"): Catheter B releases both silver ions and degradable silver particles into the urethra and urinary bladder upon catheterization.
Enterococcus Faecalis Mean Bacteria Count Change From Baseline to 24 Hours	-51498 CFU/mL Standard Deviation 73684	20999983 CFU/mL

SECONDARY outcome

Timeframe: Baseline to 24 hours

Population: Per protocol, excluding five subjects with extreme outlier values at baseline due to laboratory error during analysis and all subjects presented normal values during study follow up.

Urine silver concentration change from baseline excluding five subjects with extreme outlier values at baseline due to laboratory error during analysis and all subjects presented normal values during study follow up. Samples for analysis of silver concentration in urine were collected at baseline, after last catheterization with investigational product (at the very end of day 2) at the last catheterization at day 3 and at study termination (at 7-14 days).

Outcome measures

Outcome measures
Measure	Catheter A n=7 Participants Silver-nitrate coated catheter ("Catheter A"): Catheter A releases silver ions into the urethra and urinary bladder upon catheterization.	Catheter B n=8 Participants Degradable silver particle-coated catheter ("Catheter B"): Catheter B releases both silver ions and degradable silver particles into the urethra and urinary bladder upon catheterization.
Urine Silver Concentration Change From Baseline to 24 Hours	5.15 nmol Ag/mmol creatinine Standard Deviation 9.70	6.20 nmol Ag/mmol creatinine Standard Deviation 5.26

SECONDARY outcome

Timeframe: After first catheterization with study product and after 48 hours

Population: Per protocol excluding five subjects with extreme outlier values at baseline due to laboratory error during analysis and all subjects presented normal values during study follow up.

Urine silver concentration change from baseline excluding five subjects with extreme outlier values at baseline due to laboratory error during analysis and all subjects presented normal values during study follow up. Samples for analysis of silver concentration in urine were collected at baseline, after last catheterization with investigational product (at the very end of day 2) at the last catheterization at day 3 and at study termination (at 7-14 days).

Outcome measures

Outcome measures
Measure	Catheter A n=7 Participants Silver-nitrate coated catheter ("Catheter A"): Catheter A releases silver ions into the urethra and urinary bladder upon catheterization.	Catheter B n=8 Participants Degradable silver particle-coated catheter ("Catheter B"): Catheter B releases both silver ions and degradable silver particles into the urethra and urinary bladder upon catheterization.
Urine Silver Concentration Change From Baseline and After 48 Hours	-0.02 nmol Ag/mmol creatinine Standard Deviation 0.11	-0.02 nmol Ag/mmol creatinine Standard Deviation 0.12

SECONDARY outcome

Timeframe: At baseline and after 7-14 days

Population: Per protocol excluding five subjects with extreme outlier values at baseline due to laboratory error during analysis and all subjects presented normal values during study follow up.

Urine silver concentration change from baseline excluding five subjects with extreme outlier values at baseline due to laboratory error during analysis and all subjects presented normal values during study follow up. Samples for analysis of silver concentration in urine were collected at baseline, after last catheterization with investigational product (at the very end of day 2) at the last catheterization at day 3 and at study termination (at 7-14 days).

Outcome measures

Outcome measures
Measure	Catheter A n=7 Participants Silver-nitrate coated catheter ("Catheter A"): Catheter A releases silver ions into the urethra and urinary bladder upon catheterization.	Catheter B n=8 Participants Degradable silver particle-coated catheter ("Catheter B"): Catheter B releases both silver ions and degradable silver particles into the urethra and urinary bladder upon catheterization.
Urine Silver Concentration Change From Baseline to 7-14 Days	0.39 nmol Ag/mmol creatinine Standard Deviation 0.53	0.10 nmol Ag/mmol creatinine Standard Deviation 0.24

SECONDARY outcome

Timeframe: After first catheterization with study product and after 24 hours

Population: ITT

Samples for analysis of silver concentration in blood were collected at baseline, after last catheterization with investigational product (at the very end of day 2) at the last catheterization at day 3 and at study termination (at 7-14 days).

Outcome measures

Outcome measures
Measure	Catheter A n=10 Participants Silver-nitrate coated catheter ("Catheter A"): Catheter A releases silver ions into the urethra and urinary bladder upon catheterization.	Catheter B n=10 Participants Degradable silver particle-coated catheter ("Catheter B"): Catheter B releases both silver ions and degradable silver particles into the urethra and urinary bladder upon catheterization.
Blood Silver Concentration Change From Baseline and After 24 Hours	-.02 nmol Ag/L Standard Deviation 0.28	0.39 nmol Ag/L Standard Deviation 0.22

SECONDARY outcome

Timeframe: After first catheterization with study product and after 48 hours

Population: ITT

Samples for analysis of silver concentration in blood were collected at baseline, after last catheterization with investigational product (at the very end of day 2) at the last catheterization at day 3 and at study termination (at 7-14 days).

Outcome measures

Outcome measures
Measure	Catheter A n=10 Participants Silver-nitrate coated catheter ("Catheter A"): Catheter A releases silver ions into the urethra and urinary bladder upon catheterization.	Catheter B n=10 Participants Degradable silver particle-coated catheter ("Catheter B"): Catheter B releases both silver ions and degradable silver particles into the urethra and urinary bladder upon catheterization.
Blood Silver Concentration Change From Baseline and After 48 Hours	0.02 nmol Ag/L Standard Deviation 0.48	0.27 nmol Ag/L Standard Deviation 0.25

SECONDARY outcome

Timeframe: After first catheterization with study product and after 7-14 days

Population: ITT

Samples for analysis of silver concentration in blood were collected at baseline, after last catheterization with investigational product (at the very end of day 2) at the last catheterization at day 3 and at study termination (at 7-14 days).

Outcome measures

Outcome measures
Measure	Catheter A n=10 Participants Silver-nitrate coated catheter ("Catheter A"): Catheter A releases silver ions into the urethra and urinary bladder upon catheterization.	Catheter B n=10 Participants Degradable silver particle-coated catheter ("Catheter B"): Catheter B releases both silver ions and degradable silver particles into the urethra and urinary bladder upon catheterization.
Blood Silver Concentration Change From Baseline and After 7-14 Days	0.31 nmol Ag/L Standard Deviation 0.54	-0.04 nmol Ag/L Standard Deviation 0.61

Adverse Events

Catheter A

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Catheter B

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Catheter A n=10 participants at risk Silver-nitrate coated catheter ("Catheter A"): Catheter A releases silver ions into the urethra and urinary bladder upon catheterization.	Catheter B n=10 participants at risk Degradable silver particle-coated catheter ("Catheter B"): Catheter B releases both silver ions and degradable silver particles into the urethra and urinary bladder upon catheterization.
General disorders Fever	0.00% 0/10 • 3 days. The study was performed during 3 days starting with a wash out during one day, then the randomized study product was used for one day, ending with a wash out day with a non-study product. Adverse events/adverse device effects were collected during all three days but only observed and reported during the 24 hours use of the test catheters. No adverse events/adverse device effects were observed during the time (24 h) prior to use of the test catheters or after (24h). Observed by the Study personnel or spontaneously reported from the subject.	10.0% 1/10 • Number of events 1 • 3 days. The study was performed during 3 days starting with a wash out during one day, then the randomized study product was used for one day, ending with a wash out day with a non-study product. Adverse events/adverse device effects were collected during all three days but only observed and reported during the 24 hours use of the test catheters. No adverse events/adverse device effects were observed during the time (24 h) prior to use of the test catheters or after (24h). Observed by the Study personnel or spontaneously reported from the subject.
General disorders Headache	0.00% 0/10 • 3 days. The study was performed during 3 days starting with a wash out during one day, then the randomized study product was used for one day, ending with a wash out day with a non-study product. Adverse events/adverse device effects were collected during all three days but only observed and reported during the 24 hours use of the test catheters. No adverse events/adverse device effects were observed during the time (24 h) prior to use of the test catheters or after (24h). Observed by the Study personnel or spontaneously reported from the subject.	20.0% 2/10 • Number of events 2 • 3 days. The study was performed during 3 days starting with a wash out during one day, then the randomized study product was used for one day, ending with a wash out day with a non-study product. Adverse events/adverse device effects were collected during all three days but only observed and reported during the 24 hours use of the test catheters. No adverse events/adverse device effects were observed during the time (24 h) prior to use of the test catheters or after (24h). Observed by the Study personnel or spontaneously reported from the subject.
Skin and subcutaneous tissue disorders Rash in the right leg	0.00% 0/10 • 3 days. The study was performed during 3 days starting with a wash out during one day, then the randomized study product was used for one day, ending with a wash out day with a non-study product. Adverse events/adverse device effects were collected during all three days but only observed and reported during the 24 hours use of the test catheters. No adverse events/adverse device effects were observed during the time (24 h) prior to use of the test catheters or after (24h). Observed by the Study personnel or spontaneously reported from the subject.	10.0% 1/10 • Number of events 1 • 3 days. The study was performed during 3 days starting with a wash out during one day, then the randomized study product was used for one day, ending with a wash out day with a non-study product. Adverse events/adverse device effects were collected during all three days but only observed and reported during the 24 hours use of the test catheters. No adverse events/adverse device effects were observed during the time (24 h) prior to use of the test catheters or after (24h). Observed by the Study personnel or spontaneously reported from the subject.
Renal and urinary disorders Frequency of micturation increased	10.0% 1/10 • Number of events 1 • 3 days. The study was performed during 3 days starting with a wash out during one day, then the randomized study product was used for one day, ending with a wash out day with a non-study product. Adverse events/adverse device effects were collected during all three days but only observed and reported during the 24 hours use of the test catheters. No adverse events/adverse device effects were observed during the time (24 h) prior to use of the test catheters or after (24h). Observed by the Study personnel or spontaneously reported from the subject.	0.00% 0/10 • 3 days. The study was performed during 3 days starting with a wash out during one day, then the randomized study product was used for one day, ending with a wash out day with a non-study product. Adverse events/adverse device effects were collected during all three days but only observed and reported during the 24 hours use of the test catheters. No adverse events/adverse device effects were observed during the time (24 h) prior to use of the test catheters or after (24h). Observed by the Study personnel or spontaneously reported from the subject.
Musculoskeletal and connective tissue disorders Wrist pain	10.0% 1/10 • Number of events 1 • 3 days. The study was performed during 3 days starting with a wash out during one day, then the randomized study product was used for one day, ending with a wash out day with a non-study product. Adverse events/adverse device effects were collected during all three days but only observed and reported during the 24 hours use of the test catheters. No adverse events/adverse device effects were observed during the time (24 h) prior to use of the test catheters or after (24h). Observed by the Study personnel or spontaneously reported from the subject.	0.00% 0/10 • 3 days. The study was performed during 3 days starting with a wash out during one day, then the randomized study product was used for one day, ending with a wash out day with a non-study product. Adverse events/adverse device effects were collected during all three days but only observed and reported during the 24 hours use of the test catheters. No adverse events/adverse device effects were observed during the time (24 h) prior to use of the test catheters or after (24h). Observed by the Study personnel or spontaneously reported from the subject.
Renal and urinary disorders Symptoms of urinary tract infection	10.0% 1/10 • Number of events 1 • 3 days. The study was performed during 3 days starting with a wash out during one day, then the randomized study product was used for one day, ending with a wash out day with a non-study product. Adverse events/adverse device effects were collected during all three days but only observed and reported during the 24 hours use of the test catheters. No adverse events/adverse device effects were observed during the time (24 h) prior to use of the test catheters or after (24h). Observed by the Study personnel or spontaneously reported from the subject.	0.00% 0/10 • 3 days. The study was performed during 3 days starting with a wash out during one day, then the randomized study product was used for one day, ending with a wash out day with a non-study product. Adverse events/adverse device effects were collected during all three days but only observed and reported during the 24 hours use of the test catheters. No adverse events/adverse device effects were observed during the time (24 h) prior to use of the test catheters or after (24h). Observed by the Study personnel or spontaneously reported from the subject.
Renal and urinary disorders Sensation of preassure in the bladder	0.00% 0/10 • 3 days. The study was performed during 3 days starting with a wash out during one day, then the randomized study product was used for one day, ending with a wash out day with a non-study product. Adverse events/adverse device effects were collected during all three days but only observed and reported during the 24 hours use of the test catheters. No adverse events/adverse device effects were observed during the time (24 h) prior to use of the test catheters or after (24h). Observed by the Study personnel or spontaneously reported from the subject.	10.0% 1/10 • Number of events 1 • 3 days. The study was performed during 3 days starting with a wash out during one day, then the randomized study product was used for one day, ending with a wash out day with a non-study product. Adverse events/adverse device effects were collected during all three days but only observed and reported during the 24 hours use of the test catheters. No adverse events/adverse device effects were observed during the time (24 h) prior to use of the test catheters or after (24h). Observed by the Study personnel or spontaneously reported from the subject.

Additional Information

Head of Medical Affairs

Wellspect Health Care

Phone: +46313763000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place