The efficacy and safty of OnabotulinumtoxinA-Injection into the bladder in patients with neurogenic bladder dysfunction due to Parkinson's disease

Not Applicable

Completed

• Conditions: ower urinary tract dysfunction in parkinsonian disease; Nervous System Diseases; Lower urinary tract dysfunction in parkinsonian disease

• Registration Number: ISRCTN11857462
• Lead Sponsor: niversity Medical Centre Schleswig-Holstein

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-10
• Last Update Posted: 24 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Patients with lower urinary tract dysfunction due to parkinsonian disease
2. Refractory to at least two different types oral antimuscarinics

Exclusion Criteria

1. Unstable neurological disease.
2. Lower urinary tract malignancy
3. Previous onabotulinumtoxinA treatment
4. Untreated lower urinary tract obstruction
5. Missing informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
rinary tract function (urinary frequency during daytime, night-time, urinary incontinence episode, post void volume) is measured using patient diaries at baseline and 4 months.

Secondary Outcome Measures

Name	Time	Method
Quality of life is measured using the International Consultation and Incontinence Questionnaire - Lower Urinary Tract Symptoms Quality of Life at baseline and 4 months.