Bladder Scan of Residual Urine With New Catheter

Urinary Incontinence Clinical Trial

Official title:

A Non-Inferiority Bladder Scan Study to Investigate Residual Urine After Use of Intermittent Catheters in Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01048541
• Other study ID #: CP061CC
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 11, 2010
• Last updated: August 2, 2012
• Start date: January 2010
• Est. completion date: June 2010

Study information

• Verified date: August 2012
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

Male intermittent catheters (ICs) range from 340-500 mm long, with the European standard minimum length being 360 mm for a catheter without a balloon and 275 mm for one with a balloon. This length is defined by hospital standards although it is known that the male urethra has an approximate maximum length of 29 cmA new intermittent catheter developed by Coloplast A/S is a 30-cm-long sterile, ready-to-use, hydrophilic-coated male catheter. There is a lack of clinical data documenting that male ICs that are shorter and more or less flexible than standard catheters can sufficiently empty the bladder of male subjects. This will be tested using ultrasound to measure residual urine in the bladder following catheterisation with new product and standard length catheter.

Description:

See brief summary

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject is a male IC user able to self-catheterise

2. Subject has used hydrophilic-coated ICs for at least 1 month

3. Subject is at least 18 years old.

4. Subject has provided informed consent.

Exclusion Criteria:

1. Subject has symptoms of UTI (ie, fever, autonomic dysreflexia, spasticity, discomfort or pain over the kidney or bladder, onset/increase in incontinence episodes, cloudy urine with increased odour, malaise, lethargy, or sense of unease).

2. Subject has known abnormalities in the lower urinary tract.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

Device:
• Test Catheter - SpeediCath Compact Male
Compact catheter for intermittent catheterisation
• SpeediCath
Catheter for intermittent catheterisation

Locations

Country	Name	City	State
Germany	Werner-Wicker-Klinik, Abteilung für Neuro-Urologie	Bad Wildungen	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Residual Urine Volume	Residual urine was mesured by ultrasound measurement of bladder content after intermittent catherisation	3 catheterisations on 1 day	No
Secondary	The Difference in Incidence of Adverse Events (AEs) and Adverse Device Events (ADEs)		Study period	Yes
Secondary	Median Absolute RU Volume		3 catheterisations on 1 day	No