A comparative study between treatment with oxybutynin and botulinum toxin type A in patients with neurogenic detrusor overactivity

ISRCTN	ISRCTN56769820
DOI	https://doi.org/10.1186/ISRCTN56769820
Secondary identifying numbers	N/A

Submission date: 30/05/2011
Registration date: 13/06/2011
Last edited: 30/06/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Ruiter Silva Ferreira
Scientific

Rua 1002, 700/301
Setor Pedro Ludovico
Goiania
74820-150
Brazil

Study information

Study design	Randomised trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
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
Study acronym	BoNTA
Study objectives	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(s)	Ethics Board Committee Faculty of Medical Sciences of State University of Campinas (UNICAMP), 24/03/2010, ref: 0098.0.146.000-10
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	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 study start date	01/04/2010
Completion date	30/11/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	68
Key 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
Key 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
Date of first enrolment	01/04/2010
Date of final enrolment	30/11/2010

Locations

Countries of recruitment

Brazil

Study participating centre

Rua 1002, 700/301

Goiania
74820-150
Brazil

Sponsor information

Dr Henrique Santillo Rehabilitation Center (Brazil)
Hospital/treatment centre

Avenida Jose Monterio, 1655
Setor Negrao de LIma
Goiania
74653-230
Brazil

Website	http://www.crer.org.br/

Funders

Funder type

Hospital/treatment centre

Dr Henrique Santillo Rehabilitation Center (Brazil)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

30/06/2017: Plain English summary added.