Submucosal versus Intradetrusor Botulinum toxin in OAB Patients Trial.
Research type
Research Study
Full title
Submucosal versus Intradetrusor Botulinum toxin in Over active bladder patients-a randomized control Trial.(SIBOT)
IRAS ID
245171
Contact name
Ravisankar Gopakumara pillai
Contact email
Sponsor organisation
The Rotherham NHS Foundation Trust
Duration of Study in the UK
1 years, 5 months, 1 days
Research summary
Over Active Bladder (OAB) is a symptom complex associated with urinary urgency and is often associated with urgency urinary incontinence. The overall prevalence of OAB in women aged over 40 years is estimated as 21% in the UK as per Medical Research Council incontinence study. Intravesical injection of botulinum toxin A (BTX) is one of the most common urology procedure in over active bladder patients whose symptoms are refractory to oral medication. Available data shows with good subjective and objective response rate to Botulinum toxin A. Despite this success in treatment there is a lack of a standardized technique or dosage for intra-vesical Botulinum Toxin A administration. The hypothesis is that in women with refractory Over Active Bladder intravesical sub mucosal botulinum toxin type A injections are associated with superior patient reported outcomes compared to intravesical intradetrusor botulinum toxin injections.
This will be a single blinded randomised control trial. The aim of the study is to compare the two different techniques by evaluating and comparing the clinical outcomes of the above mentioned groups in terms of Over active Bladder Symptom score (OABSS), International Consultation of Incontinence Questionnaire-Short Form ( ICIQ-SF),Incontinence Impact Questionnaire-7 (IIQ-7) and bladder diary. This study also assess the duration of therapeutic effect determined as the period between the treatment day and the day of recurrence of lower urinary tract symptoms of similar severity to those at baseline.REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
18/NW/0467
Date of REC Opinion
17 Jul 2018
REC opinion
Further Information Favourable Opinion