Utilising the LiNA OperaScope for the administration of intravesical botox under local anaesthetic

Yang B1, Olanipekun H1, Foley S1

Research Type

Clinical

Abstract Category

Overactive Bladder

Abstract 444
Open Discussion ePosters
Scientific Open Discussion Session 15
Thursday 28th September 2023
10:20 - 10:25 (ePoster Station 1)
Exhibit Hall
Voiding Dysfunction Detrusor Overactivity Female
1. Royal Berkshire Hospital UK
Presenter
Links

Poster

Abstract

Hypothesis / aims of study
Intravesical Onabotulinum toxin A (BOTOX) is a well-established treatment for women with overactive bladders. The current standard of care is to administer under a general or local anaesthetic via a rigid or flexible cystoscope. However, a significant amount of equipment is required including a surgical stack system, onsite sterilisation facilities as well as the need for a sizeable operating space and the ability to deliver and recover from a general anaesthetic.

The LiNA OperaScope system is an all-in-one disposable scope with a built-in screen and working channel, negating the need for the paraphernalia associated with standard cystoscopes and general anaesthetics.

We, therefore, investigated the tolerability and feasibility of performing intravesical BOTOX administration under local anaesthetic using the LiNA OperaScope system in an outpatient setting.
Study design, materials and methods
50 women with overactive bladders refractory to medical treatment underwent 100 units of BOTOX administration (diluted in 10mls of Normal Saline 0.9%) under local anaesthetic (Instillagel) using the LiNA OperaScope system and a retractable BOTOX needle.

Feedback from both the surgeon and the patients were recorded. The patient's tolerability of the procedure were also recorded and compared to their previous cervical smear test experience.
Results
All 50 patients successfully underwent the procedure. On average, the "pain level" reported afterwards by the patient for the procedure was 1/10 (range 1-3). The "pain level" of their previous cervical smear test was reported to be on average 3/10 (range 1-5).

The set-up, use and visualisation of the scope as well as performing the procedure itself was reported to be “very good” by the surgeon on a visual analogue scale.

There was one case of equipment failure where the quality of the image on the built-in screen was diminished. The procedure was still completed with no immediate issues.

There were 2 post-procedure UTIs, both successfully treated with oral antibiotics only (Clavien-Dindo II complication).
Interpretation of results
The LiNA OperaScope system appears to be a safe and viable modality in administering BOTOX under local anaesthetic in women, with excellent tolerability reported by patients and ease of use reported by the surgeons.

The procedure itself appears better tolerated than a cervical smear test and acts as a good benchmark when consenting patients for this procedure.

Longer-term data is needed on the efficacy of the BOTOX administered in this manner and direct comparison is required with the current standard of care.
Concluding message
This study demonstrates for the first time the utilisation of the novel LiNA OperaScope system in delivering BOTOX in an outpatient setting, potentially facilitating an easier transition of the service out of the operating room. This is particularly important in light of the current COVID-19 waiting list backlogs.

Furthemore, a clinician can use this data as valuable information when guiding their patients prior to surgery by demonstrating the tolerability of the procedure and benchmarking it against their previous smear test.
Disclosures
Funding Kebomed UK was the sponsor for this project Clinical Trial No Subjects Human Ethics not Req'd Audit on clinical outcomes Helsinki Yes Informed Consent Yes
27/04/2025 23:04:48