Condition category
Nervous System Diseases
Date applied
04/08/2016
Date assigned
10/08/2016
Last edited
07/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Parkinson’s disease (PD) is a common movement disorder, affecting approximately 120,000 people in the UK. It is a lifelong condition, which involves the gradual loss of nerve cells (neurons) in a part of the brain called the substantia nigra. These neurons are normally responsible for producing dopamine, a chemical messenger (neurotransmitter) which carries signals around the brain that help to coordinate movement. In people suffering from PD, these neurons gradually die over time, causing the level of dopamine in the brain to gradually fall. As the levels of dopamine become lower, the brain is unable to coordinate movement as effectively, causing abnormal movements such as stiffness, tremor (uncontrollable shaking) and slowness of movement (bradykinesia). Neurogenic detrusor overactivity (NDO), also known as overactive bladder, is a common complication of PD. It causes a range of symptoms, such as the need to urinate more frequently and/or urgently, the need to get up in the night to urinate and incontinence. It happens because damage to the nerves involved in bladder activity can lead to involuntary contractions (squeezing) of the bladder muscle leading to urinary leaking. Treating this can be difficult, as most of the available therapies do not work or cause significant side effects. OnabotulinumtoxinA (Botox) injections have been shown to be a well-tolerated, effective treatment for NDO. The aim of this study is to find out whether a single Botox injection could help alleviate NDO while still allowing patients to urinate when they want to.

Who can participate?
Adults with NDO caused by PD.

What does the study involve?
All participants are treated with a single 200 IU injection of OnabotulinumtoxinA into the detrusor muscle (muscle which forms a layer of the wall of the bladder) and a neuro-urological evaluation. The neuro-urological evaluation consists of having medical history taken, having an ultrasound scan of the bladder and completing questionnaires about bladder function and quality of life. Four months later, the neuro-urological evaluation is repeated in order to find out whether the injection has led to improved bladder function and quality of life.

What are the possible benefits and risks of participating?
There is a chance that participants be benefit from an improvement in their bladder function following the Botox injection. There are no notable risks involved with participating.

Where is the study run from?
University Medical Centre Schleswig-Holstein (Germany)

When is the study starting and how long is it expected to run for?
April 2007 to December 2015

Who is funding the study?
University Medical Centre Schleswig-Holstein (Germany)

Who is the main contact?
Dr Stephanie C Knüpfer

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stephanie C. Knüpfer

ORCID ID

Contact details

Department of Urology and Pediatric Urology
University Medical Centre Schleswig-Holstein
Campus Kiel
Arnold-Heller-Street 3
Kiel
24105
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

Study hypothesis

200 IU OnabotulinumtoxinA injection would effectively alleviate the lower urinary tract dysfunction in the patient group and voluntary voiding would still be possible.

Ethics approval

Ethikkommission Kiel AZ, 27/02/2013, ref: D416/13

Study design

Single-centre prospective non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Lower urinary tract dysfunction in parkinsonian disease

Intervention

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.

Intervention type

Drug

Phase

Not Applicable

Drug names

OnabotulinumtoxinA

Primary outcome measures

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 outcome measures

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

Overall trial start date

01/04/2007

Overall trial end date

01/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

A total of 10 patients

Participant 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

Recruitment start date

20/04/2007

Recruitment end date

18/06/2012

Locations

Countries of recruitment

Germany

Trial participating centre

University Medical Centre Schleswig-Holstein
Department of Urology and Pediatric Urology Campus Kiel Arnold-Heller-Street 3
Kiel
24105
Germany

Sponsor information

Organisation

University Medical Centre Schleswig-Holstein

Sponsor details

Department of Urology
Arnold-Heller-Strasse 3
Kiel
24105
Germany

Sponsor type

Not defined

Website

Funders

Funder type

Hospital/treatment centre

Funder name

University Medical Centre Schleswig-Holstein

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

Intention to publish date

01/10/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27596481

Publication citations

Additional files

Editorial Notes

06/09/2016: Publication reference added.