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ISRCTN
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ISRCTN57577615
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ClinicalTrials.gov identifier
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Public title
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Botulinum toxin-A in sensory urgency
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Scientific title
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Acronym
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N/A
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Serial number at source
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BTXSENS
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Study hypothesis
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Botulinum toxin-A will improve symptoms related to sensory urgency.
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Lay summary
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Not provided at time of registration
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Ethics approval
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No Ethics Approval as of 05/07/2006 - Guy's and St Thomas research ethics committee will review the protocol
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Study design
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Randomised double blind placebo controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Sensory urgency, overactive bladder
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Participants - inclusion criteria
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1. 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
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Participants - exclusion criteria
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1. 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
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Anticipated start date
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01/10/2006
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Anticipated end date
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01/10/2009
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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64 patients
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Interventions
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Intervention 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.
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Primary outcome measure(s)
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Urodynamics: Maximum cystometric capacity
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Secondary outcome measure(s)
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1. 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)
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Sources of funding
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Unrestricted educational grant from Allergan, Ltd
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Trial website
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Publications
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1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21564444
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Contact name
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Mr
Mohammad
Khan
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Address
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Department of Urology
1st floor Thomas Guy House
Guy’s Hospital
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City/town
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London
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Zip/Postcode
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SE1 9RT
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Country
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United Kingdom
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Sponsor
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Guy's and St Thomas' NHS Trust (UK)
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Address
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Research & Development Department
Counting House
Guy’s Hospital
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City/town
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London
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Zip/Postcode
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SE1 9RT
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Country
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United Kingdom
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Sponsor website:
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http://www.guysandstthomas.nhs.uk/
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Date applied
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05/07/2006
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Last edited
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10/01/2012
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Date ISRCTN assigned
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21/09/2006
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