iTind - Procedure Guide 3/5

This procedure guide will take you through the steps required to implant and remove iTind. This technique has been adopted by Mr. Neil Barber of the Frimley Benign Prostate Clinical Research Centre at Frimley Health NHS Foundation Trust (UK).

Olympus as distributor does not practice medicine. Therefore, the information on the products and procedures contained in this document is of a general nature and does not represent medical advice or recommendations. This information does not purport to constitute any diagnostic or therapeutic statement with regard to any individual medical case. Each patient must be examined and advised individually, and this document does not replace the need for such examination and/or advice in whole or in part.

This procedure guide is a voluntary service of Olympus, compiled with the greatest possible care. The guide is not meant to replace the instructions for use. Any user of the iTind must at all times observe all mandatory information for the iTind, in particular contained on the labels and the instructions for use.

The following is required for the implantation procedure using a rigid cystoscope:
· iTind device.
· Rigid cystoscope with
          – min. 19 Fr. sheath (e.g. 19.8 or 22.5 Fr. Olympus sheath).
          – 12° or 30° telescope.
· Scissors or scalpel.
· Surgical tape.

Recommended patient preparation for the implantation of iTind (not obligatory):
· Light intravenous sedation / IV Propofol.
· Anesthetic gel.
· Prophylactic antibiotics.

· Open the pouch and prepare the iTind so that it is ready for deployment.
· Pass the cystoscope into the bladder.
· Fill the bladder with sterile saline.
· Observe the urethra and bladder to rule out any contraindications, such as obstructive median lobe (IPP > 1) or bladder pathology.
· Remove any bladder stones or blood clots, if present.

· Hold the sheath of the rigid cystoscope in the bladder, and withdraw the telescope.
· Insert the iTind, folded within the introducer sheath, into the cystoscope sheath.
· Advance the iTind until you feel the device release into the bladder.
· Withdraw the introducer sheath and set aside.

· Remove the sheath of the rigid cystoscope, ensuring that the iTind remains in the bladder.
· Under vision, reinsert the rigid cystoscope alongside the guidewire into the bladder.
· Advance the rigid cystoscope until the iTind is visualized inside the bladder.

· Fill the bladder with saline to enable visibility and easy rotation of the iTind.
· Differentiate between the double intertwined struts and the smooth anchoring leaflet.
· Maneuver the iTind so that the anchoring leaflet is oriented at the 6 o’clock position.

· While holding the device in position, slowly pull the cystoscope back until the bladder neck is visible.
· Pull the iTind back into the prostatic urethra until the anchoring leaflet passes over the bladder neck and falls into the base of the bladder neck, just before the verumontanum.
· Advance the optics toward the bladder neck to ensure that the distal end of the device is protruding slightly into the bladder.
· If needed, use the guidewire to advance the distal end of the device over the bladder neck.
· Ensure that both the anchoring leaflet and distal end are correctly positioned before continuing.

· Empty the bladder through the cystoscope sheath.
· Withdraw the cystoscope until the external sphincter is visible and ensure that it is not being held open by the device.
· Loosen the slipknot at the proximal end of the guidewire and slide it off, exposing the retrieval suture.
· Remove the cystoscope from the urethra.

· Loop the retrieval suture and loosely fasten it to the patient’s penis with surgical tape.
· Leave enough slack to allow for an erection and to minimize irritation of the meatus while the device is in situ.
· Instruct the patient not to pull, cut or damage the retrieval suture during the implantation period (5-7 days).

· Patients should be discharged only after a successful voiding trial.