GLYDO (lidocaïne) - Anesthésie locale de contact et lubrification

Key points

Approval of reimbursement for local contact anaesthesia and lubrication for cystoscopy, catheterisation, instrumental investigation procedures and other endourethral procedures for adult and adolescent male and female patients only.

Disapproval of reimbursement for other marketing authorisation indications.

Therapeutic improvement?

No therapeutic improvement in relation to other lidocaine-based proprietary urethral gel medicinal products already listed (XYLOCAINE 2% (lidocaine), urethral gel in prefilled syringe). 

Role in therapeutic strategy?

• Local anaesthesia for cystoscopy, catheterisation, instrumental investigation and other endourethral procedures

Based on expert opinion, most urological investigations are performed without sedation or general anaesthesia and on an outpatient basis. For this type of endoscopic procedure, sterile aqueous gel must be used. However, some endourethral procedures may be unpleasant, such as patients who need to perform urinary self-catheterisation (particularly for men).

Given that pain management is a key concern for interventional practitioners, the use of an anaesthetic and lubricant gel may also be proposed when the procedure is painful.

For children:

• cystoscopy is performed under general anaesthesia
• bladder catheterisation may be performed for a urinary cytobacteriology test or to carry out cystography to detect vesicoureteral reflux and in the event of an abnormality detected by ultrasound. In these cases, it is recommended to use a lubricant.

Role of GLYDO 20 mg/mL (lidocaine), gel in prefilled syringe in the therapeutic strategy:

Introducing a new lidocaine-based proprietary medicinal product is not likely to modify the Committee’s opinion on other lidocaine-based proprietary medicinal products (in urethral gel already available) used prior to urological investigation (XYLOCAINE 2% (lidocaine), urethral gel in prefilled syringe) in adults and adolescents.

It is a first-line treatment for preventive pain management in urological investigations.

As mentioned in the summary of product characteristics, the Committee points out the importance of waiting at least 5 minutes before conducting urological examinations in order to obtain suitable local anaesthesia. The anaesthesia lasts for approximately 20 to 30 minutes.

For children (2 to 11 years), the effect of lidocaine hydrochloride monohydrate gels is not clearly documented and demonstrated. The systemic uptake of lidocaine may be increased and caution is therefore required. As such, lidocaine in urethral gel form has no role for children prior to a urological investigation procedure.

• Local anaesthesia for rectoscopy

Rectoscopy is preceded by a digital anorectal examination enabling lubrication, and the apparatuses are then introduced into the anus after having been lubricated themselves. In routine practice, based on expert opinion, lubrication is provided by water-based lubricant gels (such as KY).

Role of GLYDO 20 mg/mL (lidocaine), gel in prefilled syringe in the therapeutic strategy:

Considering the lack of clinical data and specific guidelines, GLYDO 20 mg/mL (lidocaine), sterile gel in prefilled syringe has no role for rectoscopy.

• Symptomatic treatment of pain associated with chronic interstitial cystitis

Painful bladder syndrome is difficult to manage. Analgesics, antispasmodics, non-steroidal anti-inflammatories/NSAIDs with a proton pump inhibitor/PPI are generally ineffective. A number of medicinal products are used off-label via the oral or parenteral route: tricyclic antidepressants (amitriptyline hydrochloride) and antihistamines (hydroxyzine) may be effective. 

The proprietary medicinal product ELMIRON (pentosan sodium) 100 mg capsules is indicated for the treatment of painful bladder syndrome characterised in particular by Hunner ulcers in adults suffering from moderate to severe pain, urgency of urination and pollakiuria.

After failure to respond to oral painful bladder syndrome treatments, the 2022 European Association of Urology (EAU) guidelines recommend:

• intravesical instillations of local anaesthetics, hyaluronic acid, chondroitin sulphate and heparin (off-label use) before setting up more invasive measures. Lidocaine has been proposed by the intravesical route to improve bladder symptoms; dimethylsulphoxide (DMSO) in bladder installations has also been used; botulinum toxin injections into the bladder have also been proposed.
• hydrodistention may provide relief for patients, but requires general anaesthesia.
• in the event of Hunner ulcers, electrocoagulation or preferably ulcer resection is recommended.

Surgery (TENS / subcutaneous sacral implant, augmentation enterocystoplasty, cystectomy, sacral root denervation, etc.) must be envisaged, as a last resort, if all other treatments have failed and the symptoms become extremely incapacitating.

Role of GLYDO 20 mg/mL (lidocaine), gel in prefilled syringe in the therapeutic strategy:

Considering the low level of evidence of the clinical data available, GLYDO 20 mg/mL (lidocaine), gel in prefilled syringe has no role in symptomatic treatment of pain associated with chronic interstitial cystitis.