Transurethral placement of the UroLume® Urethral Stent is a minimally invasive procedure that can typically be performed within 10-30 minutes.

Caution: This information is for educational purposes only. See the Operating Room Manual, Instructions for Use and procedural videos for more detailed instructions about this procedure.

Instrumentation
The UroLume stent is delivered sterile and preloaded in a disposable delivery tool. The delivery instrument has an inner lumen to receive a standard, 12Fr optical telescope (cystoscope) for direct visualization of the stent and the urethra throughout the procedure. The irrigation port permits a constant washing of the urethra and telescope to allow for better visualization.

The delivery instrument features a retractable sheath. By manipulating the finger grips, you are able to draw back and advance the sheath until you find the optimum position for deployment.

To prevent inadvertent release of the stent during the procedure, the delivery instrument is equipped with two security buttons.

The rounded, 24Fr collar at the tip of the delivery tool eases insertion into the urethra.

Instrumentation for the procedure includes:

• Urethral sounds
• A 12Fr optic telescope (0-12 degrees for BPH)
• An irrigation setup
• Cystoscope
• AMS Urethral Measuring Catheter or a graduated ureteric catheter
• UroLume stent kits (at least two of each size)

Procedure Overview
Typical patient preparation includes preoperative antibiotics, placing the patient in the lithotomy position, skin prep and drape and anesthesia. Anesthesia varies according to the disease being treated. For BPH, use anesthesia as you would for cystoscopy.

The placement procedure consists of these steps:

Step 1: Cystourethroscopy
To prepare for placement of the UroLume stent, perform a diagnostic cystourethroscopy.

Step 2: Measurement
Use an AMS Urethral Measuring Catheter or a graduated ureteric catheter to take the appropriate measurements. In a patient with BPH, measure the length of the prostatic urethra, from bladder neck to mid verumontanum.

Step 3: Stent Selection
The method for selecting the correct size varies according to the disease. For BPH, select a stent that is 0.5 cm shorter than the measured length of the prostatic urethra.
Example:

3.5	= measured length of prostatic urethra
-0.5
3.0	= required length of stent

Step 4: Delivery Tool Preparation
Open the selected UroLume package and prepare the deployment system for the procedure:

• Attach the light source to the telescope.
• Attach the water source to the irrigation port on the delivery instrument.
• Insert the telescope into the telescope stabilizer and then place the stabilizer into the delivery instrument.
• Apply a small amount of sterile lubricant over the outer shaft to facilitate passage into the urethra.

Step 5: Stent Placement

• Dilate the meatus to at least 24Fr and insert the delivery instrument into the urethra.
• Position the delivery instrument so that its rounded collar is in the correct location. For BPH, this is proximal to the bladder neck.
• Partially deploy the stent and reposition it if necessary.
• Release the stent.
• Withdraw the delivery tool.

Some important points about stent placement for BPH patients:

• The stent must cover the entire prostate, including the anterior section of the lateral lobes. Place the stent from the bladder neck to the verumontanum.
• Ensure that the stent does not protrude into the bladder, or encrustation could occur.
• The stent should not extend into the perineal sphincter, or the patient will become incontinent.
• If more than one stent is required to adequately cover the prostatic urethra, the first stent placed should cover the most proximal (nearest the bladder neck) end of the prostatic urethra. The stents should overlap by at least 5 mm.

Step 6: Endoscopy
Proceeding with care, perform normal endoscopy.

Post-Operative Care
Routine post-procedural care should include prophylactic antibiotics. Do not use a urethral catheter and do not perform a cystoscope for eight weeks until the stent is stabilized by urothelial ingrowth. Additionally, patients should be counseled to avoid activities that place abnormal forces upon the urethra, such as frequent cycling or horseback riding.