Plain English Summary
Background and study aims
Traumatic spinal cord injury often causes neurogenic bladder dysfunction, where the patient is unable to control their bladder. Patients with neurogenic bladder dysfunction frequently struggle with urinary incontinence that may severely affect their quality of life. Oral anticholinergic medications such as oxybutynin have been widely used as a first-line treatment option for urinary incontinence. However, this class of medications does not work in some patients and may also cause side effects such as dry mouth, constipation, or blurred vision. Injections of botulinum toxin type A (BoNTA) into the bladder muscle has become a second-line option for patients who are unable to tolerate anticholinergic drugs or whose response to these drugs is unsatisfactory. BoNTA has proven effective at improving bladder function and quality of life. The aim of this study is to compare the effects of oral oxybutynin and BoNTA injections on the bladder function and quality of life of patients with bladder dysfunction resulting from spinal cord injury.
Who can participate?
Patients aged over 18 who had had a spinal cord injury for at least 12 months and who have been regularly undergoing catheterisation for bladder dysfunction
What does the study involve?
Participants are randomly allocated to be treated with either oral oxybutynin or BoNTA injections. Bladder function and quality of life are compared between the two groups.
What are the possible benefits and risks of participating?
The risks to participants are the side effects of oxybutynin, such as dry mouth, constipation, or blurred vision, and rare generalised muscular weakness caused by BoNTA.
Where is the study run from?
Dr Henrique Santillo Rehabilitation Center (Brazil)
When is the study starting and how long is it expected to run for?
April 2010 to November 2010
Who is funding the study?
Dr Henrique Santillo Rehabilitation Center (Brazil)
Who is the main contact?
Dr Ruiter Silva Ferreira
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A comparative study between oxybutynin and botulinum toxin type A in patients with neurogenic detrusor overactivity: urodynamic response and impact of treatment on quality of life: a randomised trial
Acronym
BoNTA
Study hypothesis
Botulinum toxin type A (BoNTA) injection into the detrusor muscle will result in improvement in urodynamic parameters, such as maximum cystometric capacity (MCC), maximum detrusor pressure (Pdetmax), and bladder compliance and on quality of life after 24 weeks when compared with oral oxybutynin in patients with detrusor overactivity (DO) resulting from spinal cord injury (SCI)
Ethics approval
Ethics Board Committee Faculty of Medical Sciences of State University of Campinas (UNICAMP), 24/03/2010, ref: 0098.0.146.000-10
Study design
Randomised trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Spinal cord injury/detrusor overactivity
Intervention
1. Group 1 (n=40) will receive 15 mg oxybutynin orally three times daily
2. Group 2 (n=28) will be treated with intradetrusor injections of 300 U BoNTA (Botox)
Intervention type
Drug
Phase
Not Applicable
Drug names
Botulinum toxin type A, oxybutynin
Primary outcome measure
Evaluation of urodynamic parameters:
1. Maximum cystometric capacity (MCC)
2. Maximum detrusor pressure (Pdetmax)
3. Bladder compliance
Secondary outcome measures
1. Evaluation of quality of life
2. Systemic side-effects
Overall trial start date
01/04/2010
Overall trial end date
30/11/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male and female patients
2. Over 18 years of age
3. Patients who have had an SCI for at least 12 months
4. Patients who have been regularly undergoing intermittent catheterisation
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
68
Participant exclusion criteria
1. Pregnancy
2. A desire to become pregnant during the study period
3. Breastfeeding
4. The use of anticoagulants or a report of a blood coagulation disorder
5. Neuromuscular transmission disorder
6. The use of any intravesical pharmacologic agents
7. Previous use of BoNTA
Recruitment start date
01/04/2010
Recruitment end date
30/11/2010
Locations
Countries of recruitment
Brazil
Trial participating centre
Rua 1002, 700/301
Goiania
74820-150
Brazil
Sponsor information
Organisation
Dr Henrique Santillo Rehabilitation Center (Brazil)
Sponsor details
Avenida Jose Monterio
1655
Setor Negrao de LIma
Goiania
74653-230
Brazil
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Dr Henrique Santillo Rehabilitation Center (Brazil)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list