Botulinum toxin-A in sensory urgency
| ISRCTN | ISRCTN57577615 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57577615 |
| Protocol serial number | BTXSENS |
| Sponsor | Guy's and St Thomas' NHS Trust (UK) |
| Funder | Unrestricted educational grant from Allergan, Ltd |
- 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
Scientific
Department of Urology
1st floor Thomas Guy House
Guys Hospital
London
SE1 9RT
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double blind placebo controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Botulinum 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) studied | Sensory urgency, overactive bladder |
| Intervention | 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. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Botulinum toxin-A |
| Primary outcome measure(s) |
Urodynamics: Maximum cystometric capacity |
| Key secondary outcome measure(s) |
1. Three day bladder voiding diaries to assess urinary frequency, urgency and incontinence episodes |
| Completion date | 01/10/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | All |
| Target sample size at registration | 64 |
| Key inclusion criteria | 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 |
| Key exclusion criteria | 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 |
| Date of first enrolment | 01/10/2006 |
| Date of final enrolment | 01/10/2009 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Urology
London
SE1 9RT
United Kingdom
SE1 9RT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/06/2011 | Yes | No |
