Health-related Quality of Life of Patients With Neurogenic Bladder

November 15, 2019 updated by: Swiss Paraplegic Centre Nottwil

Effects of Bladder Management on Health-related Quality of Life in Patients With Neurogenic Bladder

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

87

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • LU
      • Nottwil, LU, Switzerland, 6207
        • Swiss Paraplegic Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

individuals with neurogenic bladder dysfunction

Description

Inclusion Criteria:

  • Individuals with neurogenic bladder dysfunction

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
neurogenic bladder dysfunction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life
Time Frame: up to year 10
Qualiveen questionnaire
up to year 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
urinary tract infections
Time Frame: year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
number of annual symptomatic urinary tract infections
year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
patient characteristics
Time Frame: time 0
gender, age, type of neurogenic bladder dysfunction, duration of neurogenic bladder dysfunction
time 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Paraplegic Centre Nottwil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

October 31, 2019

Study Completion (Actual)

November 14, 2019

Study Registration Dates

First Submitted

June 26, 2014

First Submitted That Met QC Criteria

June 30, 2014

First Posted (Estimate)

July 1, 2014

Study Record Updates

Last Update Posted (Actual)

November 18, 2019

Last Update Submitted That Met QC Criteria

November 15, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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