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Bladder Scan of Residual Urine With New Catheter

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Coloplast

Status and phase

Completed
Phase 3
Phase 2

Conditions

Urinary Incontinence

Treatments

Device: Test Catheter - SpeediCath Compact Male
Device: SpeediCath

Study type

Interventional

Funder types

Industry

Identifiers

NCT01048541
CP061CC

Details and patient eligibility

About

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.

Full description

See brief summary

Enrollment

37 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

37 participants in 2 patient groups

SpeediCath catheter
Active Comparator group
Description:
Standard treatment
Treatment:
Device: SpeediCath
Test product
Experimental group
Treatment:
Device: Test Catheter - SpeediCath Compact Male

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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