BULKAMID STANDARD OPERATING PROCEDURE

BULKAMID STANDARD OPERATING PROCEDURE

Contents 1 1 2 3-4 5-6 5-6 7 9-12 9 10 11 12 13 13 13 15 16 Products Bulkamid multiple use instruments Bulkamid single use instruments The Bulkamid system Pre-procedure preparation Assembly of the Bulkamid system Patient positioning and preparation Bulkamid procedure Emptying of the bladder Identification of needle entry point Initial injection site Subsequent injection sites Post-operative care Possible transient events Top up injection of Bulkamid Troubleshooting Ordering information / helpline

Products Bulkamid multiple use instruments (Autoclave) Bulkamid single use instruments Product code & description Contents Product code & description BUSC Bulkamid sterilisation container. BUOP Bulkamid optic with accessories. 1. Zero-degree Bulkamid urethroscope with universal optic (length 11cm). 2. Universal adapters to fit all light cables. Contents BUKIT Bulkamid urethral system. 1. 2 x 1ml Bulkamid hydrogel syringes. 1. 2 x 23G, 12cm needles. 1. 1 x Bulkamid rotatable sheath. Sterilisation instructions 3. Protection sheath for transportation. BU10 Bulkamid 1ml syringe. 1. 1 x 1ml Bulkamid hydrogel syringe. The Bulkamid sterilisation container, optic, universal adaptors and protection sheath should be washed at 95 o C prior to being sterilised in an autoclave at either: - 134 o C for 5 to 20 minutes, or - 137 o C for 3 to 18 minutes. Sterilisation may also be performed using the STERRAD System (gas plasma technology). Ensure that the protective sheath is separated from the urethroscope during sterilisation. Standard equipment required for a Bulkamid procedure Theatre equipment Light cable (standard grey cable). Drip stand with 1-3L saline. Standard infusion set without internal valve. Equipment for disinfection of the vulva. Disposable Ch. 10-12 catheter. Hegar dilators (available in the operating theatre, if required). Anaesthetic Anaesthetic gel: lidocaine gel with adrenaline and/or Instillagel (for application inside the urethra and /or on the rotatable sheath). Anaesthetic injection: 10ml of lidocaine 0.5 1% with adrenaline (epinephrine), 1 x 10ml syringe and a 23G x 3cm needle. Protective sheath Zero-degree Bulkamid urethroscope 1 2

The Bulkamid system Needle channel 1ml hydrogel syringe with luer lock Rotatable sheath (360-degree rotation) diameter CH22 23G 12cm long needle Bulkamid urethroscope (camera connection fits all standard cameras) Light cable connection (fits all standard systems with the use of different adaptors) Water inflow (blue) Water outflow (red) 3 4

Pre-procedure preparation Assembly of the Bulkamid system 1. Attach the light cable to the Bulkamid urethroscope (ensure the correct adaptor has been used, if required). 4. Remove any air bubbles from the irrigation system by opening the blue inflow tap. Once all air bubbles have been removed the blue inflow tap is closed. 5. (a) Remove the cap from the Bulkamid syringe and (b) attach the 23G needle (turn anti-clockwise until tight). b. attach needle to syringe (turn anti-clockwise). a. remove syringe cap. Light cable 2. Place the optic into the Bulkamid rotatable sheath (ensure the light cable and irrigation tubes are pointing in the same direction). Make sure that the needle is correctly mounted onto the syringe to prevent leakage of hydrogel during the procedure, or the needle being pushed off the syringe tip. 6. (a) Remove the protection sheath and (b) the rubber stopper from the needle. A click will be heard when the optic is fully inserted into the rotatable sheath. a b 3. Attach the irrigation system to the rotatable sheath via the inflow (blue) and outflow (red) tubes (make sure the red and blue taps are closed before opening the water tap on the irrigation system). 7. Prime the needle by advancing the syringe plunger until hydrogel appears at the tip of the needle. This will remove any air from the Bulkamid system. Irrigation system This completes the assembly of the Bulkamid system 5 6

Patient positioning and preparation 1. Place the patient in the lithotomy position. 2. Drape the patient and disinfect the vulva in accordance with local protocol. 3. Place anaesthetic gel or lidocaine inside the urethra, and/or inject 5-10 ml lidocaine with adrenaline 0.5-1% or similar bilaterally to the mucosa along the urethra (3 and 9 o clock) 5-10 minutes prior to the procedure. Anaesthetic gel If an anaesthetic gel is used, keep the remaining gel to one side for use on the tip of the rotatable sheath, prior to the sheath being inserted into the urethra. Anaesthetic injection Surgeons may choose a 3cm/21G needle to inject anaesthetic into the submucosa tissue, 5-10 minutes prior to procedure. This needle allows the anaesthetic to be positioned at the level where the Bulkamid hydrogel will be injected, while causing minimal trauma to the surrounding tissue. Prophylactic antibiotics To minimise the possibility of urinary tract infection, it is advised to administer prophylactic antibiotics in accordance with the local anti-microbial protocol prior to surgery. 7 8

Bulkamid procedure Emptying of the bladder (if required) Dilation of the urethra The Bulkamid rotatable sheath is Ch. 22 (7-8 Hegar dilator). If the urethral meatus is too narrow dilation with Hegar dilators may be required prior to insertion of the rotatable sheath. 1. Place local anaesthetic gel onto the rotatable sheath and carefully advance the Bulkamid system into the urethra until the bladder is visualised and inspected (ensure the blue inflow tap is open and the red outflow tap is closed). 2. Close the blue inflow tap and retract the optic from the rotatable sheath to allow the bladder to empty or open the red outflow tap. Identification of needle entry point Alignment of monitor and needle position Before identifying the first needle entry point make sure the 12 o clock position on the monitor corresponds to the 12 o clock position of the needle on the rotatable sheath. This will allow accurate placement of the Bulkamid injections. Orientation of light cable and irrigation system To allow free movement of the rotatable sheath from 3 o clock to 9 o clock throughout the procedure it is recommended to align the light cables and irrigation tubes at 12 o clock (facing upwards), on top of the Bulkamid optic and rotatable sheath. Stabilisation of the urethra set up of correct irrigation flow Irrigation should be set to full inflow (blue tap) with the outflow (red tap) closed throughout the procedure. This will help to stabilise the urethra and allow for the precise positioning of Bulkamid hydrogel in the proximal half of the urethra. Patient comfort If the patient experiences the need to void during the procedure the bladder can be emptied by separating the optic from the Bulkamid rotatable sheath or by closing the blue inflow tap and opening the red outflow tap. 1. Insert the Bulkamid needle into the needle channel on the rotatable sheath until the needle is just visible on the monitor but is not in contact with the urethral tissue. Rotate the sheath so that the tip of the needle is in line with the first injection site (e.g. 6 o clock). 2. Advance the rotatable sheath towards the bladder until the needle tip is adjacent to the bladder neck. 3. Reinsert the optic once the bladder is empty. 3. Retract the Bulkamid system distally while advancing the needle through the needle channel, until the needle is fully extended. Take care to maintain the position of the needle tip at the bladder neck. Then, fully retract the needle into the rotatable sheath. 9 10

Initial injection site (e.g. 6 o clock) Subsequent injection sites (e.g. 2 and 10 o clock)* 4. Carefully press the Bulkamid system parallel against the urethral wall until mucosa appears in front of the needle tip. Note: if angulation of the Bulkamid system occurs at this stage it may result in the injections being too deep or superficial and affect treatment efficacy. In order to minimise the risk of angulation ensure the urethral lumen remains in the centre of the screen whilst inserting the needle. Rotation of sheath When rotating the sheath to the next injection site, ensure that the position of the Bulkamid system is maintained within the urethra and only the rotatable portion of the sheath is moved. This will ensure that all injection sites are at the same level/plane and coaptation of the urethra is effectively achieved. It may be useful to use previous injection sites as an indicator for the needle entry point of future sites. Ensure the sheath is not advanced past the bladder neck Take care not to introduce the Bulkamid system past the bladder neck once the first bleb has been injected as this may cause extravasation of the Bulkamid hydrogel. 5. Advance the needle into the submucosal tissue, ensuring that the needle pathway is parallel to the urethral wall. The bevel of needle should be pointing towards the urethral lumen at all times. Continue to advance the needle into the submucosal layer until the 1cm mark on the needle is aligned with the tissue surface. 8. Turn the rotatable sheath to the next injection site. The first injection site may be used as a guide for the level of needle entry. 9. Advance the needle into the urethral tissue (until the 1cm mark on the needle is in line with the tissue surface). 10. Inject the Bulkamid hydrogel until the urethral wall (bleb) reaches the midline of the urethra, cushioning up against the first bleb. 6. Inject the Bulkamid hydrogel until the urethral tissue (bleb) reaches the midline. Note: if a bleb does not begin to form, slowly retract the Bulkamid system whilst injecting the hydrogel until the correct plane is reached and the bleb begins to form. Alternatively, fully retract the needle from the tissue and reinsert the needle at a shallower angle prior to injecting Bulkamid. 7. Retract the needle into the rotatable sheath. 11. Retract the needle into the rotatable sheath. Repeat steps 8 11 at the remaining injection locations to achieve complete coaptation of the urethra. Once the final bleb has been injected the bladder should be emptied using the disposable Ch. 10-12 catheter. Take care not to use the rotatable sheath or any other hard tube to empty the bladder as this may cause extravasation of the hydrogel. *or 3, 9 and 12 o clock if 4 blebs are required. 11 12

Post-operative care After the patient s first void the residual urine volume should be measured. If the residual volume is 100ml the patient can be discharged. Patients may resume normal work and daily activities within 24 hours of the procedure. Possible transient events Difficulty in voiding postoperatively. If this occurs the patient may be instructed to perform intermittent catheterisation with a disposable 10-12 Ch. catheter. Pain and light bleeding during the first voiding episodes. Urinary tract infection. Top up injection of Bulkamid If a top up injection is required to improve treatment efficacy this can be carried out 4-6 weeks after the initial injection. 13 14

Troubleshooting Ordering information Situation Possible actions Item number Description The Bulkamid hydrogel is not causing a bleb to form. This can occur if the needle angle is too steep causing the Bulkamid hydrogel to be placed deep to the submucosal tissues. This may be resolved by: slowly retracting the Bulkamid needle whilst injecting the hydrogel until the correct plane is reached and the bleb begins to form, or adjust angulation of the Bulkamid system by retracting the needle from the tissues and reinserting it at a shallower angle prior to injecting Bulkamid. BUKIT BU10 BUOP BUSC Bulkamid urethral system Bulkamid 1 ml syringe Bulkamid urethroscopic optic Bulkamid sterilisation container The bleb is forming but is has not reached the midline of the urethra. The patient s bladder keeps filling up during the procedure. If the Bulkamid hydrogel has been injected into the correct plane (submucosal tissue) but the bleb has not reached the midline it may be due to an insufficient volume of the hydrogel being injected. This may be resolved by: injecting additional hydrogel into the existing bleb through the same needle pathway used in the initial injection. If the bladder keeps filling up during the procedure it can be emptied between injections by: removing the optic from the sheath (ensure the sheath does not pass the bladder neck, as this may cause extravasation of the existing blebs). altering the irrigation flow. Partially close the inflow (blue tap) on the irrigation system to reduce the flow of water entering the bladder and fully open the outflow (red tap) to increase the volume of fluid leaving the bladder. inserting a disposable CH 10-12 catheter. Please do not hesitate to contact us if you have any queries concerning our products. Contura International A/S Sydmarken 23, 2860 Soeborg Denmark Tel: +45 81 100 900 E-mail: info@bulkamid.com It is difficult to maintain visualisation of the internal meatus in the middle of the camera screen. This is often caused by an inconsistent irrigation flow which causes excessive movement of the urethra. This movement can be addressed by maintaining a consistent irrigation flow throughout the procedure. This will also help to stabilise the urethra and subsequently the position of the internal meatus. Suggested irrigation flow is: inflow (blue tap) fully open. outflow (red tap) closed. 15 16

Contura Limited 14 Took s Court, London EC4A 1LB Tel: +44 (0)20 7421 7400, Fax: +44 (0)20 7421 7401 www.bulkamid.com, orders@bulkamid.com www.contura.com January 2018 BULK/2017/041.2