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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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24 October 2016 |
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Main ID: |
ISRCTN11857462 |
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Date of registration:
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10/08/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The efficacy and safty of OnabotulinumtoxinA-Injection into the bladder in patients with neurogenic bladder dysfunction due to Parkinson's disease
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Scientific title:
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Preserved micturition after intradetrusor onabotulinumtoxinA injection for treatment of neurogenic bladder dysfunction in Parkinson’s disease |
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Date of first enrolment:
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20/04/2007 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN11857462 |
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Study type:
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Interventional |
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Study design:
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Single-centre prospective non-randomised study (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Germany
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Stephanie C.
Knüpfer |
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Address:
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Department of Urology and Pediatric Urology
University Medical Centre Schleswig-Holstein
Campus Kiel
Arnold-Heller-Street 3
24105
Kiel
Germany |
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Lower urinary tract dysfunction in parkinsonian disease
Nervous System Diseases
Lower urinary tract dysfunction in parkinsonian disease
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Intervention(s)
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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 injection was given gently and penetration of the detrusor muscle and thus injection into perivesical tissues was prevented.
At baseline and four months, participants undergo a neuro-urological evaluation, consisting of medical history, clinical examination, urine analysis, urinary tract ultrasound, urodynamic investigation, urethrocystoscopy and validated questionnaire contains 19 items on various aspects of quality of life. Urodynamics are performed according to good urodynamic practices as recommended by the International Continence Society (ICS). Patients are investigated in a sitting position. The bladder is filled with a room temperature mixture of 0.9% NaCL solution and contrast medium. The clinical examination includes digital rectal examination, vaginal inspection, and transrectal sonography.
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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Quality of life is measured using the International Consultation and Incontinence Questionnaire - Lower Urinary Tract Symptoms Quality of Life at baseline and 4 months.
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Source(s) of Monetary Support
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University Medical Centre Schleswig-Holstein
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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