|
ISRCTN
|
ISRCTN16995641
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
The effects of botulinum toxin A on patients with idiopathic detrusor overactivity. A double-blind, randomised, placebo-controlled trial.
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
BOTOX Study Protocol
|
|
Study hypothesis
|
Botulinum toxin A at 200 units will improve urinary frequency, urgency and incontinence episodes, urodynamic variables and quality of life compared with placebo.
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised double blind placebo controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Overactive bladder symptoms and idiopathic detrusor overactivity.
|
|
Participants - inclusion criteria
|
1. Refractory to traditional anticholinergic therapy either due to poor efficacy or side effects
2. Proven detrusor overactivity on urodynamic studies
3. Detrusor overactivity of non-neurogenic origin
|
|
Participants - exclusion criteria
|
1. Pregnancy or planned pregnancy
2. Breast Feeding
3. Indwelling catheter
4. Current anticoagulation e.g. heparin or warfarin
5. Neurogenic detrusor overactivity
6. Painful bladder syndromes
7. Previous bladder surgery e.g. augmentation cystoplasty
|
|
Anticipated start date
|
01/05/2004
|
|
Anticipated end date
|
31/03/2006
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
32
|
|
Interventions
|
Baseline: voiding diary, urodynamics, quality of life (QoL) questionnaires.
Flexible cystoscopy and 3 bladder biopsies followed by injection of either 200 u of botulinum toxin A (20 injections at 10 u/ml/site) versus placebo (normal saline 20 injections at 1 ml/site.
Follow-up: At 4 and 12 weeks: urodynamics, voiding diary, flexible cystoscopy and 3 bladder biopsies, QoL questionnaires.
At 3 months patients are unblinded. Those that received placebo will be offered Botulinum toxin treatment.
Follow-up will be extended to confirm longevity of treatment. A further follow-up time point of 6 months will be instigated collecting the same data as at 4 and 12 weeks.
|
|
Primary outcome measure(s)
|
1. Urinary frequency/24 hours
2. Maximum cystometric capacity
|
|
Secondary outcome measure(s)
|
1. Urinary urgency/24 hours
2. Urge incontinence/24 hours
3. QoL: 3 validated QoL questionnaires (KHQ, UDI6, IIQ7)
4. Urodynamic variables:
4.1. time to first invluntary detrusor contraction
4.2. maximum detrusor pressure on filling/voiding
4.3. post void residual
|
|
Sources of funding
|
1. British Urological Foundation (UK)
2. Allergan Ltd. (UK) - Unrestricted educational grany
|
|
Trial website
|
|
|
Publications
|
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19389019
|
|
Contact name
|
Mr
Mohammad Shamim
Khan
|
|
Address
|
Department of Urology
1st Floor Thomas Guy House
Guy's Hospital
|
|
City/town
|
London
|
|
Zip/Postcode
|
SE1 9RT
|
|
Country
|
United Kingdom
|
|
Sponsor
|
Guy's and St Thomas' NHS Foundation Trust (UK)
|
|
Address
|
Guy's Hospital
St Thomas' Street
|
|
City/town
|
London
|
|
Zip/Postcode
|
SE1 9RT
|
|
Country
|
United Kingdom
|
|
Date applied
|
16/09/2005
|
|
Last edited
|
13/10/2009
|
|
Date ISRCTN assigned
|
19/10/2005
|
