Condition category
Urological and Genital Diseases
Date applied
12/09/2010
Date assigned
04/10/2010
Last edited
04/10/2010
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 Rustom Manecksha

ORCID ID

Contact details

c/o Marjorie White-Flynn
Lane Ward
Adelaide & Meath Hospital
Dublin
24
Ireland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Prospective randomised controlled trial comparing trigonal versus trigone-sparing intradetrusor injection of botulinum toxin-a for refractory idiopathic detrusor overactivity

Acronym

Study hypothesis

Trigonal injections result in a better outcome

Ethics approval

Joint Hospitals Research Ethics Committee, Adelaide and Meath Hospital, Dublin approved on the 23rd October 2008 (ref: 2008/08/13)

Study design

Interventional randomised controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Idiopathic detrusor overactivity

Intervention

Patients will be randomised to receive intradetrusor injections of 500u Botulinum Toxin-A (Dysport) sparing the trigone or including the trigone. 500u Dysport will be reconstituted with 20ml 0.9% saline. For trigone-sparing patients, 1 ml will be injected into 20 sites around the bladder sparing the trigone. For trigone-including patients, five 1 ml injections will be administered into the trigone and 15 injections around the bladder outside the trigone.

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

Overactive Bladder Symptom Score (OABSS) Questionnaire Total Score at baseline and at 6 weeks after injection (score range 7-28)

Secondary outcome measures

1. OABSS Questionnaire Total Score are 12 and 26 weeks (score range 7-28)
2. OABSS urgency subscale score at 6, 12 and 26 weeks (score range 4-16)
3. Urodynamic parameters at baseline and at 6 weeks
4. Specifically maximum detrusor pressure
5. Maximum cystometric capacity
6. Volume at first desire to void
7. Volume at urgent desire to void
8. Post void residual volume
9. Time to symptom recurrence

Overall trial start date

15/09/2010

Overall trial end date

15/11/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male and female patients, 17 years and over
2. Urodynamic-confirmed detrusor overactivity
3. Have failed greater than or equal to 6 weeks anticholinergic therapy or discontinued therapy due to intolerability

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

22

Participant exclusion criteria

1. Patients with any neurological condition or coagulopathies
2. Men with clinical or urodynamic evidence of bladder outflow obstruction
3. Patients with active urinary tract infection
4. Women with positive pregnancy test

Recruitment start date

15/09/2010

Recruitment end date

15/11/2010

Locations

Countries of recruitment

Ireland

Trial participating centre

c/o Marjorie White-Flynn
Dublin
24
Ireland

Sponsor information

Organisation

Adelaide and Meath Hospital (Ireland)

Sponsor details

Department of Urology
Dublin
24
Ireland

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Adelaide and Meath Hospital, Dublin (Ireland) - internal funding

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

Publication citations

Additional files

Editorial Notes