NCT01048541

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

September 3, 2012

Completed
Last Updated

September 3, 2012

Status Verified

August 1, 2012

Enrollment Period

5 months

First QC Date

January 11, 2010

Results QC Date

January 9, 2012

Last Update Submit

August 2, 2012

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

  • Mean Residual Urine Volume

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

    3 catheterisations on 1 day

Secondary Outcomes (2)

  • The Difference in Incidence of Adverse Events (AEs) and Adverse Device Events (ADEs)

    Study period

  • Median Absolute RU Volume

    3 catheterisations on 1 day

Study Arms (2)

SpeediCath catheter

ACTIVE COMPARATOR

Standard treatment

Device: SpeediCath

Test product

EXPERIMENTAL
Device: Test Catheter - SpeediCath Compact Male

Interventions

Test Catheter - SpeediCath Compact MaleDEVICE

Compact catheter for intermittent catheterisation

Also known as: SpeediCath, Test catheter
Test product
SpeediCathDEVICE

Catheter for intermittent catheterisation

Also known as: Test catheter
SpeediCath catheter

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is a male IC user able to self-catheterise
  • Subject has used hydrophilic-coated ICs for at least 1 month
  • Subject is at least 18 years old.
  • Subject has provided informed consent.

You may not qualify if:

  • 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).
  • Subject has known abnormalities in the lower urinary tract.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Werner-Wicker-Klinik, Abteilung für Neuro-Urologie

Bad Wildungen, Hesse, 34537, Germany

Location

Related Publications (2)

  • Prieto JA, Murphy CL, Stewart F, Fader M. Intermittent catheter techniques, strategies and designs for managing long-term bladder conditions. Cochrane Database Syst Rev. 2021 Oct 26;10(10):CD006008. doi: 10.1002/14651858.CD006008.pub5.

    PMID: 34699062DERIVED

  • Domurath B, Kutzenberger J, Kurze I, Knoth HS. Clinical evaluation of a newly developed catheter (SpeediCath Compact Male) in men with spinal cord injury: residual urine and user evaluation. Spinal Cord. 2011 Jul;49(7):817-21. doi: 10.1038/sc.2011.14. Epub 2011 Mar 1.

    PMID: 21358718DERIVED

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Kristine Gjødsbøl, PhD
Organization
Coloplast
dkkg@coloplast.com
+4549113557

Study Officials

  • Burkhard Domurath, Dr. med.

    Werner Wicker Klinik

    PRINCIPAL INVESTIGATOR

  • Henrik S Knoth, M.Sc Pharm

    Coloplast A/S

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2010

First Posted

January 13, 2010

Study Start

January 1, 2010

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

September 3, 2012

Results First Posted

September 3, 2012

Record last verified: 2012-08

Locations

DE(1)