Botox under local anaesthetic for OAB
Research type
Research Study
Full title
A prospective cohort study of intravesical botulinum toxin A with flexible cystoscopy under local anaesthetic for the treatment of overactive bladder (OAB).
IRAS ID
151562
Contact name
Ruben Trochez
Contact email
Sponsor organisation
Liverpool Women's NHS Foundation Trust
Research summary
Overactive bladder (OAB) syndrome is a distressing condition that affects millions of women worldwide. It causes urinary urgency and frequency, and urinary incontinence, amongst other symptoms. Botulinum toxin A (BOTOX®) injections to the bladder is an effective treatment which can be done under local (LA) or general anaesthetic (GA). The two injection techniques are different and a different type of device to see into the bladder and inject Botox (cystoscope) is used: flexible and rigid, respectively.
There is very little data in the literature comparing these two techniques. Most studies report the use of rigid cystoscopy with general or spinal anaesthesia. However as repeat injections are invariably required this represents a cost and time burden to services. The obvious advantages of Botox under LA are the ease of an outpatient service management, cost savings, avoidance of general anaesthesia and the lack of necessity for preoperative preparation.
This study aims to answer the question “Is botulinum toxin A (BOTOX®) for the treatment of overactive bladder as effective when injected under local anaesthetic using a flexible cystoscope when compared to the same treatment under general anaesthetic with a rigid cystoscope?
We will recruit a cohort of women with OAB to have Botox injections into the bladder under local anaesthetic using a flexible cystoscope; and will compare their outcomes with a cohort of historical controls who had the same procedure done under GA with a rigid cystoscope.
The study will be carried out in the Liverpool Women’s Hospital, which is a tertiary referral centre with expertise in the conduct of Research trials. The study is expected to last for 12 months from initial recruitment to the discharge of the last patient from the study.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
14/NW/0209
Date of REC Opinion
7 May 2014
REC opinion
Further Information Favourable Opinion