Treatment delivery Frequency of use: Re-treatment could be considered appropriate upon recurrence or deterioration of symptoms if a maintenance regimen has not been implemented. Duration of use: After 8 weeks should no significant reduction in symptoms be seen, treatment would be stopped. Clinical setting: Administration will be performed in the specialist consulting rooms, in private hospitals and aged care facilities – places where urethral catheterization can competently take place by trained personnel. Pre-procedure patient preparation: Minimal – light sedation for some patients. Personnel performing the procedure; Urologist, uro-gynaecologists, gynaecologists, urology nurses (under supervision), and other clinical practitioners trained in urothelial catheterisation. Additional equipment or product required for performing the procedure: 8Ch catheter, sterile swab for cleaning urethral opening, anaesthetic gel for catheter insertion, jar for excess urine collection). Additional training required before medical staff can administer the product: Nil. This service is not for investigative purposes. This service includes the use of a registered trademarked device, iAluRil®. This product contains sterile solution of sodium hyaluronate (1.6% - 800 mg/50 mL) and sodium chondroitin sulphate (2% - 1 g /50 mL). Delivery as a 50 mL pre-filled syringe for intravesical instillation. Proposed Setting The proposed setting for the delivery of this service is outpatient settings such as clinics or consulting rooms. The product can also be used in a hospital in-patient setting. Details of the delivery of this service include: The procedure is to be performed by qualified personnel under controlled and sterile conditions. The procedure can be performed in clinic/surgery rooms by a trained nurse, general practitioner or urologist, or in a hospital setting by adequately trained staff. The intended treatment duration is 12 weeks (7 instillations) or longer depending on the severity of symptoms and chance of remission. iAluRil is instilled directly into the bladder using a thin tube (in/out catheter) that is passed through the urethra into the bladder. Note: An in/out catheter is used rather than an indwelling catheter. Co-dependent information Not applicable.
Treatment delivery Frequency of use: Re-treatment could be considered appropriate upon recurrence or deterioration of symptoms if a maintenance regimen has not been implemented. Duration of use: After 8 weeks should no significant reduction in symptoms be seen, treatment would be stopped. Clinical setting: Administration will be performed in the specialist consulting rooms, in private hospitals and aged care facilities – places where urethral catheterization can competently take place by trained personnel. Pre-procedure patient preparation: Minimal – light sedation for some patients. Personnel performing the procedure; Urologist, uro-gynaecologists, gynaecologists, urology nurses (under supervision), and other clinical practitioners trained in urothelial catheterisation. Additional equipment or product required for performing the procedure: 8Ch catheter, sterile swab for cleaning urethral opening, anaesthetic gel for catheter insertion, jar for excess urine collection). Additional training required before medical staff can administer the product: Nil. This service is not for investigative purposes. This service includes the use of a registered trademarked device, iAluRil®. This product contains sterile solution of sodium hyaluronate (1.6% - 800 mg/50 mL) and sodium chondroitin sulphate (2% - 1 g /50 mL). Delivery as a 50 mL pre-filled syringe for intravesical instillation. Proposed Setting The proposed setting for the delivery of this service is outpatient settings such as clinics or consulting rooms. The product can also be used in a hospital in-patient setting. Details of the delivery of this service include: The procedure is to be performed by qualified personnel under controlled and sterile conditions. The procedure can be performed in clinic/surgery rooms by a trained nurse, general practitioner or urologist, or in a hospital setting by adequately trained staff. The intended treatment duration is 12 weeks (7 instillations) or longer depending on the severity of symptoms and chance of remission. iAluRil is instilled directly into the bladder using a thin tube (in/out catheter) that is passed through the urethra into the bladder. Note: An in/out catheter is used rather than an indwelling catheter. Co-dependent information Not applicable.
1439-FinalProtocol.docx