NCT00324233

Brief Summary

Intermittent catheterization is a well-known method used for emptying the bladder. The objective of this study is to compare the residual urine after intermittent catheterisation with 2 different, hydrophilic coated, intermittent catheters. The study is a randomized, single blinded, crossover study including 24 healthy males.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Apr 2006

Shorter than P25 for not_applicable healthy

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

April 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 10, 2006

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
6.6 years until next milestone

Results Posted

Study results publicly available

January 1, 2013

Completed
Last Updated

January 1, 2013

Status Verified

November 1, 2012

Enrollment Period

2 months

First QC Date

May 9, 2006

Results QC Date

January 9, 2012

Last Update Submit

November 29, 2012

Conditions

Healthy

Keywords

Residual urineHematuriaUltra sound

Outcome Measures

Primary Outcomes (1)

  • Residual Urine Measured by Ultra Sound

    2

Secondary Outcomes (2)

  • Subjectively Measured Handling

  • Subjectively Measured Insertion of the Catheter

Study Arms (2)

SC

ACTIVE COMPARATOR

Speedicath (SC) catheter is a catheter for intermittent catherisation

Device: Intermittent catheter

SCCM

EXPERIMENTAL

SpeediCath Compact Male (SCCM) is a compact catheter for intermittent catherisation to be used by males

Device: Compact intermittent catheter

Interventions

Intermittent catheterDEVICE

SpeediCath catherter (SC) for intermittent catherisation

SC
Compact intermittent catheterDEVICE

SpeediCath Compact Male catheter (SCCM) is a compact intermittent catheter for males

SCCM

Eligibility Criteria

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

You may qualify if:

  • Male
  • years and above
  • A negative urine dip-stick
  • Have signed informed written consent to participate

You may not qualify if:

  • The test participant has previous or current congenital deformity, diseases or operation in the lower urinary tract

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, København Ø, 2100, Denmark

Location

MeSH Terms

Conditions

Hematuria

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

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

Study Officials

  • Per Bagi, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2006

First Posted

May 10, 2006

Study Start

April 1, 2006

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

January 1, 2013

Results First Posted

January 1, 2013

Record last verified: 2012-11

Locations

DK(1)