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

ISRCTN	ISRCTN12589059
DOI	https://doi.org/10.1186/ISRCTN12589059
Secondary identifying numbers	N/A

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

Study design	Interventional randomised controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details below to request a patient 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	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 study start date	15/09/2010
Completion date	15/11/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

Sponsor information

Adelaide and Meath Hospital (Ireland)
Hospital/treatment centre

Department of Urology
Dublin
24
Ireland

"ROR"	https://ror.org/01fvmtt37

Funders

Funder type

Hospital/treatment centre

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan