Condition category
Urological and Genital Diseases
Date applied
16/09/2005
Date assigned
19/10/2005
Last edited
13/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Mohammad Shamim Khan

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BOTOX Study Protocol

Study information

Scientific title

Acronym

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.

Ethics approval

Not provided at time of registration

Study design

Randomised double blind placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Botulinum toxin A (Botox®)

Primary outcome measures

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 trial start date

01/05/2004

Overall trial end date

31/03/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

32

Participant 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

Recruitment start date

01/05/2004

Recruitment end date

31/03/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Urology
London
SE1 9RT
United Kingdom

Sponsor information

Organisation

Guy's and St Thomas' NHS Foundation Trust (UK)

Sponsor details

Guy's Hospital
St Thomas' Street
London
SE1 9RT
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Industry

Funder name

British Urological Foundation (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Allergan Ltd. (UK) - Unrestricted educational grany

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19389019

Publication citations

  1. Results

    Sahai A, Dowson C, Khan MS, Dasgupta P, Improvement in quality of life after botulinum toxin-A injections for idiopathic detrusor overactivity: results from a randomized double-blind placebo-controlled trial., BJU Int., 2009, 103, 11, 1509-1515, doi: 10.1111/j.1464-410X.2009.08402.x.

Additional files

Editorial Notes