Trigonal versus trigone-sparing intradetrusor injection of Botulinum Toxin-A for idiopathic detrusor overactivity

ISRCTN	ISRCTN12589059
DOI	https://doi.org/10.1186/ISRCTN12589059
Protocol serial number	N/A
Sponsor	Adelaide and Meath Hospital (Ireland)
Funder	Adelaide and Meath Hospital, Dublin (Ireland) - internal funding

Submission date: 12/09/2010
Registration date: 04/10/2010
Last edited: 04/10/2010

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

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Rustom Manecksha
Scientific

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

Study information

Primary study design	Interventional
Study design	Interventional randomised controlled study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Prospective randomised controlled trial comparing trigonal versus trigone-sparing intradetrusor injection of botulinum toxin-a for refractory idiopathic detrusor overactivity
Study objectives	Trigonal injections result in a better outcome
Ethics approval(s)	Joint Hospitals Research Ethics Committee, Adelaide and Meath Hospital, Dublin approved on the 23rd October 2008 (ref: 2008/08/13)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Overactive Bladder Symptom Score (OABSS) Questionnaire Total Score at baseline and at 6 weeks after injection (score range 7-28)
Key secondary outcome measure(s)	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
Completion date	15/11/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	22
Key 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
Key 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
Date of first enrolment	15/09/2010
Date of final enrolment	15/11/2010

Locations

Countries of recruitment

Ireland

Study participating centre

c/o Marjorie White-Flynn

Dublin
24
Ireland

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?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes