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

Preserved micturition after intradetrusor onabotulinumtoxinA injection for treatment of neurogenic bladder dysfunction in Parkinson’s disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11857462

Enrollment

Registered

2016-08-10

Start date

2007-04-20

Completion date

Unknown

Last updated

2016-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower urinary tract dysfunction in parkinsonian disease Nervous System Diseases Lower urinary tract dysfunction in parkinsonian disease

Interventions

All participants are treated with a single 200 IU injection of OnabotulinumtoxinA into the detrusor muscle distributed among 16-17 submucosal/ intradetrusor sites and 3-4 sites into the trigone. The i

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Urinary 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

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

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026