Condition category
Urological and Genital Diseases
Date applied
05/07/2006
Date assigned
21/09/2006
Last edited
10/01/2012
Prospective/Retrospective
Prospectively 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 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

BTXSENS

Study information

Scientific title

Acronym

Study hypothesis

Botulinum toxin-A will improve symptoms related to sensory urgency.

Ethics approval

No Ethics Approval as of 05/07/2006 - Guy's and St Thomas research ethics committee will review the protocol

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

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 names

Botulinum toxin-A

Primary outcome measures

Urodynamics: Maximum cystometric capacity

Secondary outcome measures

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)

Overall trial start date

01/10/2006

Overall trial end date

01/10/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

64 patients

Participant 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

Recruitment start date

01/10/2006

Recruitment end date

01/10/2009

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 Trust (UK)

Sponsor details

Research & Development Department
Counting House
Guy’s Hospital
London
SE1 9RT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.guysandstthomas.nhs.uk/

Funders

Funder type

Industry

Funder name

Unrestricted educational grant from Allergan, Ltd

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

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21564444

Publication citations

  1. Results

    Dowson C, Sahai A, Watkins J, Dasgupta P, Khan MS, The safety and efficacy of botulinum toxin-A in the management of bladder oversensitivity: a randomised double-blind placebo-controlled trial., Int. J. Clin. Pract., 2011, 65, 6, 698-704, doi: 10.1111/j.1742-1241.2011.02663.x.

Additional files

Editorial Notes