NCT02179073

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

December 1, 2007

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 1, 2014

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2019

Completed
Last Updated

November 18, 2019

Status Verified

November 1, 2019

Enrollment Period

11.9 years

First QC Date

June 26, 2014

Last Update Submit

November 15, 2019

Conditions

Neurogenic Bladder Dysfunction

Outcome Measures

Primary Outcomes (1)

  • quality of life

    Qualiveen questionnaire

    up to year 10

Secondary Outcomes (3)

  • bladder evacuation method

    year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10

  • urinary tract infections

    year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10

  • patient characteristics

    time 0

Study Arms (1)

neurogenic bladder dysfunction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

individuals with neurogenic bladder dysfunction

You may qualify if:

  • Individuals with neurogenic bladder dysfunction

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2014

First Posted

July 1, 2014

Study Start

December 1, 2007

Primary Completion

October 31, 2019

Study Completion

November 14, 2019

Last Updated

November 18, 2019

Record last verified: 2019-11

Locations

CH(1)