Health-related Quality of Life of Patients With Neurogenic Bladder

Neurogenic Bladder Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02179073
• Other study ID #: 2007-02
• Status: Completed
• Start date: December 2007
• Est. completion date: November 14, 2019

Study information

• Verified date: November 2019
• Source: Swiss Paraplegic Centre Nottwil
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: November 14, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Individuals with neurogenic bladder dysfunction

Exclusion Criteria:

• Insufficient dexterity to fill in the questionnaire

• Insufficient proficiency in the German or French language

Related Conditions & MeSH terms

• Neurogenic Bladder Dysfunction
• Urinary Bladder, Neurogenic

Locations

Country	Name	City	State
Switzerland	Swiss Paraplegic Centre	Nottwil	LU

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Paraplegic Centre Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of life	Qualiveen questionnaire	up to year 10
Secondary	bladder evacuation method	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
Secondary	urinary tract infections	number of annual symptomatic urinary tract infections	year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
Secondary	patient characteristics	gender, age, type of neurogenic bladder dysfunction, duration of neurogenic bladder dysfunction	time 0