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Health-related Quality of Life of Patients With Neurogenic Bladder

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ClinicalTrials.gov Identifier: NCT02179073
Recruitment Status : Enrolling by invitation
First Posted : July 1, 2014
Last Update Posted : December 14, 2017
Sponsor:
Information provided by (Responsible Party):
Swiss Paraplegic Centre Nottwil

Brief Summary:
Bladder management has a major impact on the quality of life in patients with neurogenic bladder dysfunction. This a prospective investigation of the effects of the method for bladder evacuation on the health-related quality of life in patients with neurogenic bladder dysfunction. The changes in health-related quality of life over time (longitudinal investigation) and the differences between the different methods for bladder evacuation will be investigated. Patients will be given a standardized and validated questionnaire annually for 10 years.

Condition or disease
Neurogenic Bladder Dysfunction

Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Bladder Management on Health-related Quality of Life in Patients With Neurogenic Bladder
Study Start Date : December 2007
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Group/Cohort
neurogenic bladder dysfunction



Primary Outcome Measures :
  1. quality of life [ Time Frame: up to year 10 ]
    Qualiveen questionnaire


Secondary Outcome Measures :
  1. bladder evacuation method [ Time Frame: year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 ]
    method for bladder evacuation (i.e. intermittent catheterization, condom urinal, reflex micturition, transurethral catheter, suprapubic catheter, sacral bladder stimulator, neuromodulation)

  2. urinary tract infections [ Time Frame: year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 ]
    number of annual symptomatic urinary tract infections

  3. patient characteristics [ Time Frame: time 0 ]
    gender, age, type of neurogenic bladder dysfunction, duration of neurogenic bladder dysfunction



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
individuals with neurogenic bladder dysfunction
Criteria

Inclusion Criteria:

  • Individuals with neurogenic bladder dysfunction

Exclusion Criteria:

  • Insufficient dexterity to fill in the questionnaire
  • Insufficient proficiency in the German or French language

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02179073


Locations
Switzerland
Swiss Paraplegic Centre
Nottwil, LU, Switzerland, 6207
Sponsors and Collaborators
Swiss Paraplegic Centre Nottwil

Responsible Party: Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier: NCT02179073     History of Changes
Other Study ID Numbers: 2007-02
First Posted: July 1, 2014    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Urinary Bladder, Neurogenic
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms