Bladder Scan of Residual Urine With New Catheter

Phase 2

Completed

• Conditions: Urinary Incontinence
• Interventions: Device: SpeediCath; Device: Test Catheter - SpeediCath Compact Male

• Registration Number: NCT01048541
• Lead Sponsor: Coloplast A/S

Brief 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.

Detailed Description

See brief summary

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-11
• Study First Submitted QC: 2010-01-12
• Study First Posted: 2010-01-13
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Results First Submitted: 2012-01-09
• Status Verified: 2012-08
• Results First Submitted QC: 2012-08-02
• Last Update Submitted: 2012-08-02
• Results First Posted: 2012-09-03
• Last Update Posted: 2012-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 37

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SpeediCath catheter	SpeediCath	Standard treatment
Test product	Test Catheter - SpeediCath Compact Male	-

Primary Outcome Measures

Name	Time	Method
Mean Residual Urine Volume	3 catheterisations on 1 day	Residual urine was mesured by ultrasound measurement of bladder content after intermittent catherisation

Secondary Outcome Measures

Name	Time	Method
The Difference in Incidence of Adverse Events (AEs) and Adverse Device Events (ADEs)	Study period
Median Absolute RU Volume	3 catheterisations on 1 day

Trial Locations

Locations (1)

Werner-Wicker-Klinik, Abteilung für Neuro-Urologie; 🇩🇪 Bad Wildungen, Hessen, Germany