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
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