NCT01477736

Brief Summary

The purpose of this study is to compare the effects of oral oxybutynin and intradetrusor injections of botulinum toxin type A on urodynamic parameters and quality of life in patients with neurogenic detrusor overactivity following spinal cord injury.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 19, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 22, 2011

Completed
Last Updated

November 22, 2011

Status Verified

November 1, 2011

Enrollment Period

1.8 years

First QC Date

November 19, 2011

Last Update Submit

November 19, 2011

Conditions

Spinal Cord Injury

Keywords

Neurogenic bladderUrodynamicQuality of life

Outcome Measures

Primary Outcomes (1)

  • The primary study outcome measure was the variation mean in the number of episodes of urinary incontinence per 24 hours, maximum cystometric capacity, maximum detrusor pressure and bladder compliance

    Beginning and 24 weeks of the study

Secondary Outcomes (1)

  • The secondary outcome measure was quality of life as measured by the Qualiveen questionnaire

    Beginning and 24 weeks of the study

Study Arms (2)

Botulinum toxin A

ACTIVE COMPARATOR
Drug: OxybutyninDrug: Botulinum toxin A

oxybutynin

ACTIVE COMPARATOR
Drug: OxybutyninDrug: Botulinum toxin A

Interventions

OxybutyninDRUG

5 mg of immediate-release oxybutynin orally 3 times daily

Botulinum toxin Aoxybutynin
Botulinum toxin ADRUG

300 U intradetrusor injection

Botulinum toxin Aoxybutynin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Spinal cord injury
  • Detrusor overactivity
  • Age over 18 years
  • Spinal cord injury at least 12 months duration
  • Undergoing regular clean intermittent catheterisation

You may not qualify if:

  • Pregnancy
  • Desire to become pregnant during the study period
  • Breastfeeding
  • Blood coagulation disorder
  • Neuromuscular transmission disorder
  • Use of any intravesical pharmacologic agents
  • Previous use of botulinum toxin A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNICAMP, Division of Urology

Campinas, São Paulo, 13083887, Brazil

Location

Related Publications (1)

  • Karsenty G, Denys P, Amarenco G, De Seze M, Game X, Haab F, Kerdraon J, Perrouin-Verbe B, Ruffion A, Saussine C, Soler JM, Schurch B, Chartier-Kastler E. Botulinum toxin A (Botox) intradetrusor injections in adults with neurogenic detrusor overactivity/neurogenic overactive bladder: a systematic literature review. Eur Urol. 2008 Feb;53(2):275-87. doi: 10.1016/j.eururo.2007.10.013. Epub 2007 Oct 16.

    PMID: 17988791BACKGROUND

Related Links

MeSH Terms

Conditions

Spinal Cord InjuriesUrinary Bladder, Neurogenic

Interventions

oxybutyninBotulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesNeurologic ManifestationsUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • RUITER S FERREIRA, Dr.

    Division of Urology of State University of Campinas, Division of Urology of Centro de Reabilitaçao e Readapatacao Dr. Henrique Santillo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

November 19, 2011

First Posted

November 22, 2011

Study Start

January 1, 2009

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

November 22, 2011

Record last verified: 2011-11

Locations

BR(1)