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Completed

NCT Number: NCT01523743

Quality of Life Intermittent Catheter Study

The purpose of this study is to compare compact intermittent catheters with standard coated intermittent catheters with regard to quality of life, using the Intermittent Self-Catheterisation Quality of life Measure.

Completed

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Key information

Conditions

Neurogenic Bladder Dysfunction Nos

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

PrivatHospitalet Danmark, privat hospital,, Charlottenlund, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Is at least 18 years of age
  • Has given written informed consent
  • Has neurogenic bladder dysfunction
  • Has used coated intermittent catheter as primarily bladder emptying method for at least 6 months
  • Is able to self-catheterise
  • Is able to use SpeediCath® compact catheters
  • If spinal cord injury subject, injury must have occurred more than 12 months ago
  • Covered by Social security system

Exclusion criteria

  • Has used SpeediCath® compact catheters (not including screening for this investigation)
  • Is admitted to rehabilitation centre
  • Subjects using primarily catheter sets
  • Is pregnant or breast-feeding

Treatment and study plan

SpeediCath Compact

Device

The SpeediCath Compact intermittent catheter is used for single-use urinary bladder drainage through the urethra.

Other names: SpeediCath®Compact Male, for male participants, SpeediCath®Compact Female, for female participants

Standard Care

Device

The coated intermittent catheter normally used by subject

Primary outcomes

  1. Quality of Life (0-100 Point)

    Time frame: 6 weeks

    Difference in intermittent self-catheterisation quality of life measure, comparing compact versus standard urinary intermittent catheters The range of the scale is 0-100 where a high score indicating a high level of Quality of Life.

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

Quality of Life Intermittent Catheter Study - A Prospective, Randomized, Cross-over, Multicenter Study Comparing Quality of Life Using Compact Versus Standard Urinary Intermittent Catheters

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 1, 2012
Registry last updated
Sep 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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