NCT00318591

Brief Summary

The purpose of this study is to investigate the frequency of urinary tract infections with symptoms in spinal cord injured patients requiring intermittent catheterization for emptying the bladder. Patients will use either a coated catheter or an uncoated catheter with gel.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
219

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2006

Longer than P75 for not_applicable

Geographic Reach
2 countries

16 active sites

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
25 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

May 25, 2011

Completed
Last Updated

February 10, 2021

Status Verified

August 1, 2015

Enrollment Period

3.5 years

First QC Date

April 26, 2006

Results QC Date

February 23, 2011

Last Update Submit

January 26, 2021

Conditions

Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

  • Occurrence of Symptomatic Urinary Tract Infections (UTIs)

    Occurrence of symptomatic urinary tract infections (UTIs). Time to first UTI

    4-6 months

Secondary Outcomes (6)

  • UTIs With Bacteriuria >=100 Colony Forming Units (CFU)/ml

    4-6 months

  • Nurse Evaluation of Catheters - Overall Satisfaction

    4-6 months

  • Patient or Caregiver's Evaluation of Catheters - Overall Satisfaction

    4-6 months

  • Nurse Time Spent on Catheterization Procedure

    4-6 months

  • Device-related or Possibly Device-related AEs

    4-6 months

  • +1 more secondary outcomes

Study Arms (2)

SpeediCath

EXPERIMENTAL

hydrophilic-coated intermittent catheter

Device: SpeediCath

Conveen Uncoated

EXPERIMENTAL

uncoated urinary intermittent catheter

Device: Conveen Uncoated

Interventions

SpeediCathDEVICE

hydrophilic coated urinary intermittent catheter

Also known as: Coated Catheter
SpeediCath
Conveen UncoatedDEVICE

Uncoated urinary intermittent catheter

Also known as: Uncoated catheter
Conveen Uncoated

Eligibility Criteria

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

You may qualify if:

  • Neurogenic bladder dysfunction requiring intermittent catheterization at least 3 times daily

You may not qualify if:

  • Treated with prophylactic antibiotics to prevent UTIs
  • Has a history of unresolved bladder-ureteral reflux and/or stones in the urinary tract

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Rancho Los Amigos National Rehabilitation Center

Downey, California, 90242, United States

Location

Santa Clara Valley Medical Center

San Jose, California, 95128, United States

Location

Craig Hospital

Englewood, Colorado, 80113, United States

Location

University of Miami

Miami, Florida, 33101, United States

Location

Shepherd Center

Atlanta, Georgia, 30309, United States

Location

Boston Medical School

Boston, Massachusetts, 02188, United States

Location

University of Michigan Helaths Systems

Ann Arbor, Michigan, 48108, United States

Location

Mayo Clinic, Saint Mary Hospital MB3CF Rehabilitation

Rochester, Minnesota, 55902, United States

Location

Kessler Institute for Rehabilitation

West Orange, New Jersey, 07052, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28303, United States

Location

The Institute for Rehabilitation and Research (TIRR)

Houston, Texas, 77030, United States

Location

University of Alberta

Edmonton, Alberta, T6G 2C8, Canada

Location

G.F.Strong Rehabilitation Centre

Vancouver, British Columbia, V5Z 2G9, Canada

Location

Parkwood Rehabilitation Centre

London, Ontario, N6A 4G5, Canada

Location

Toronto Rehabilitation Centre

Toronto, Ontario, M4G 3V9, Canada

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Anna Karina Busch, Intl. Senior Scientific Manager
Organization
Coloplast
dkakb@coloplast.com
+45 49112350

Study Officials

  • Diana Cardenas, MD

    University of Miami

    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
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2006

First Posted

April 27, 2006

Study Start

April 1, 2006

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

February 10, 2021

Results First Posted

May 25, 2011

Record last verified: 2015-08

Locations

US(12)CA(4)