Trial Outcomes & Findings for Bladder Scan of Residual Urine With New Catheter (NCT NCT01048541)

NCT ID: NCT01048541

Last Updated: 2012-09-03

Results Overview

Residual urine was mesured by ultrasound measurement of bladder content after intermittent catherisation

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 37 participants
• Primary outcome timeframe: 3 catheterisations on 1 day
• Results posted on: 2012-09-03

Participant Flow

Participant milestones

Measure	AB: First Test Catheter Then Standard Catheter Test catheter (SpeediCath Compact Male)used in the first period and Standard catheter (SpediCath straight) used in the second period	BA: First Standard Catheter Then Test Catheter Standard catheter (SpediCath straight)used in the first period and test catheter (SpeediCath Compact Male) used in the second period
Overall Study STARTED	18	19
Overall Study COMPLETED	17	19
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	AB: First Test Catheter Then Standard Catheter Test catheter (SpeediCath Compact Male)used in the first period and Standard catheter (SpediCath straight) used in the second period	BA: First Standard Catheter Then Test Catheter Standard catheter (SpediCath straight)used in the first period and test catheter (SpeediCath Compact Male) used in the second period
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Bladder Scan of Residual Urine With New Catheter

Baseline characteristics by cohort

Measure	Entire Study n=37 Participants Includes groups randomized to standard catheter first and test catheter first
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age Continuous	39.5 years STANDARD_DEVIATION 12.7 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants
Region of Enrollment Germany	37 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 catheterisations on 1 day

Residual urine was mesured by ultrasound measurement of bladder content after intermittent catherisation

Outcome measures

Measure	Test Catheter n=36 Participants Test catheter (SpeediCath Compact Male)	Standard Catheter n=36 Participants Standard catheter (SpediCath straight)
Mean Residual Urine Volume	12.4 mL Standard Deviation 15.7	9.4 mL Standard Deviation 11.4

SECONDARY outcome

Timeframe: Study period

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 catheterisations on 1 day

Outcome measures

Outcome data not reported

Adverse Events

Test Catheter

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Standard Catheter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Test Catheter n=36 participants at risk Test catheter (SpeediCath Compact Male)	Standard Catheter n=36 participants at risk Standard catheter (SpediCath straight)
Renal and urinary disorders Burning in the urethra	2.8% 1/36	0.00% 0/36

Additional Information

Kristine Gjødsbøl, PhD

Coloplast

Phone: +4549113557

Email: dkkg@coloplast.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60