Botulinum toxin-A in sensory urgency

ISRCTN ISRCTN57577615
DOI https://doi.org/10.1186/ISRCTN57577615
Secondary identifying numbers BTXSENS
Submission date
05/07/2006
Registration date
21/09/2006
Last edited
10/01/2012
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

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Mohammad Khan
Scientific

Department of Urology
1st floor Thomas Guy House
Guy’s Hospital
London
SE1 9RT
United Kingdom

Study information

Study designRandomised double blind placebo controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesBotulinum toxin-A will improve symptoms related to sensory urgency.
Ethics approval(s)No Ethics Approval as of 05/07/2006 - Guy's and St Thomas research ethics committee will review the protocol
Health condition(s) or problem(s) studiedSensory urgency, overactive bladder
InterventionIntervention group: Botulinum toxin-A will be administered at 100-150 units.
Control group: Placebo (normal saline solution) will be administered in the same way as the intervention group.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Botulinum toxin-A
Primary outcome measureUrodynamics: Maximum cystometric capacity
Secondary outcome measures1. Three day bladder voiding diaries to assess urinary frequency, urgency and incontinence episodes
2. Validated quality of life questionnaires:
a. King’s Health Questionnaire (KHQ)
b. Incontinence Impact Questionnaire short form (IIQ-7)
c. Urogenital Distress Inventory short form (UDI-6)
Overall study start date01/10/2006
Completion date01/10/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit80 Years
SexAll
Target number of participants64 patients
Key inclusion criteria1. Informed consent to participate
2. Male and females 18 to 80 years of age
3. Symptoms of overactive bladder
4. Refractory to anticholinergics
5. No evidence of detrusor overactivity on urodynamic studies
Key exclusion criteria1. Pregnancy or planned pregnancy in the next year
2. Breast feeding
3. Painful bladder syndrome or interstitial cystitis
4. Evidence of significant outflow obstruction
5. Indwelling catheter
6. Previous bladder surgery e.g. augmentation cystoplasty
7. Previous urological use of botulinum toxin
8. Other bladder pathology e.g. tumours, active infection
9. Proven detrusor overactivity
10. Current anticoagulation treatment e.g. heparin, warfarin
Date of first enrolment01/10/2006
Date of final enrolment01/10/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Urology
London
SE1 9RT
United Kingdom

Sponsor information

Funders

Funder type

Industry

Unrestricted educational grant from Allergan, Ltd

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/2011 Yes No
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