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Quality of Life Intermittent Catheter Study

NCT01523743 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2016-09-30

Study results available
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Summary

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.

Conditions

  • Neurogenic Bladder Dysfunction Nos

Interventions

DEVICE

SpeediCath Compact

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

DEVICE

Standard care

The coated intermittent catheter normally used by subject

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Emmanuel Chartier-Kastler, Proff · Hôpital Raymond poincarè, Service d'Urologie, Garches, France

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-04-30
Completion
2012-05-31

Countries

  • Denmark
  • France
  • Germany
  • Norway
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01523743 on ClinicalTrials.gov