Condition category
Urological and Genital Diseases
Date applied
30/05/2011
Date assigned
13/06/2011
Last edited
30/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Ruiter Silva Ferreira

ORCID ID

Contact details

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

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 measures

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

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

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

30/06/2017: Plain English summary added.