The effects of botulinum toxin A on patients with idiopathic detrusor overactivity. A double-blind, randomised, placebo-controlled trial.
| ISRCTN | ISRCTN16995641 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16995641 |
| Secondary identifying numbers | BOTOX Study Protocol |
- Submission date
- 16/09/2005
- Registration date
- 19/10/2005
- Last edited
- 13/10/2009
- 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 Shamim Khan
Scientific
Scientific
Department of Urology
1st Floor Thomas Guy House
Guy's Hospital
London
SE1 9RT
United Kingdom
Study information
| Study design | Randomised double blind placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Botulinum toxin A at 200 units will improve urinary frequency, urgency and incontinence episodes, urodynamic variables and quality of life compared with placebo. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Overactive bladder symptoms and idiopathic detrusor overactivity. |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Botulinum toxin A (Botox®) |
| Primary outcome measure | 1. Urinary frequency/24 hours 2. Maximum cystometric capacity |
| Secondary outcome measures | 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 |
| Overall study start date | 01/05/2004 |
| Completion date | 31/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 32 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2004 |
| Date of final enrolment | 31/03/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Urology
London
SE1 9RT
United Kingdom
SE1 9RT
United Kingdom
Sponsor information
Guy's and St Thomas' NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Guy's Hospital
St Thomas' Street
London
SE1 9RT
England
United Kingdom
"ROR" |
https://ror.org/00j161312 |
|---|
Funders
Funder type
Industry
British Urological Foundation (UK)
No information available
Allergan Ltd. (UK) - Unrestricted educational grany
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2009 | Yes | No |
