THE LONG-TERM SOLUTION FOR MALE INCONTINENCE

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1 THE LONG-TERM SOLUTION FOR MALE INCONTINENCE Urogyn BV Transistorweg 5a 6534 AT Nijmegen The Netherlands t +31(0) info@urogynbv.com

2 THE FIRST INJECTABLE IMPLANT THAT CAN COMPETE WITH SLINGS LONG-LASTING Unlike most other bulking agents, Prolastic is not biodegradable. It does not shrink and it maintains its volume. This makes Prolastic a long-lasting solution for stress urinary incontinence (SUI) in men. NO MIGRATION Prolastic is easy to inject and polymerizes in situ into a uniform biocompatible elastomer within seconds after application. It remains flexible and adapts to its environment, reducing the chances of migration to practically zero. REMOVABLE Prolastic is visible using ultrasound or X-ray. The implant shows no in-growth of tissue and can therefore be removed easily if deemed necessary. MINIMALLY INVASIVE Prolastic is performed under local anesthesia in a minimally invasive outpatient procedure. Prolastic is a trademark of Urogyn bv. rev.0 2

3 ADVANTAGES FOR USING THE PROLASTIC PROCEDURE FAST PROCEDURE MOST PATIENTS CAN GO HOME THE SAME DAY AND RESUME THEIR ACTIVITIES PERI-URETHRAL INJECTION SO NO DAMAGE OF THE URETHRAL MUCOSA THE EFFECT OF THE TREATMENT CAN BE OBSERVED IMMEDIATELY AFTER THE PROCEDURE MINIMALLY INVASIVE PROCEDURE USING LOCAL ANESTHESIA VERY COST EFFECTIVE COMPARED TO ALTERNATIVE TREATMENTS 3

4 EQUIPMENT USED THE PROLASTIC KIT THE PROLASTIC KIT CONTAINS: 1. Dispenser gun for the dual syringe. 2. Pre-filled 5 ml dual syringe with a lock fitting, containing 2 x 2.5 ml (1:1) Prolastic elastomer composition. 3. Two static mixers. 4. Two 18-gauge 70 mm needles. 5. Instruction for use. 6. Patient labels (3) AUXILIARY MATERIALS TO BE PROVIDED BY THE HOSPITAL 1. Endoscopic equipment. 2. C-arm X-ray equipment. 3. Irrigation fluid. 4. Radio contrast medium. 5. Local anesthetic and syringe for injection (for intravenous anesthesia, appropriate equipment and staff must be available). Prolastic is a trademark of Urogyn bv. rev ml disposable syringe. 7. Sterile gauzes. 8. Standard disinfectant solution. 9. Sterile cups.

5 PRE-OPERATIVE PROCEDURES Prior to treatment, the patient must undergo a physical examination and thorough evaluation to ensure proper patient selection. The Prolastic procedure is straightforward and may be performed as an outpatient procedure. This procedure may be performed under local or intravenous anesthesia, depending on the patient s preference. The patient s urine should be tested in advance to exclude urinary tract infection (UTI). One dose of oral antibiotic (Ciprofloxacin, 500 mg) and one dose of oral NSAID should be given at the start of the procedure. The patient must be prepared for routine endoscopy. Prior to treatment, the condition of the tissue must be evaluated (e.g. hardness, edema, hematoma, atrophy) at the site of injection. The conditions of any previous treatments must be evaluated (e.g. radiotherapy, TURP, sling) Place the patient in lithotomy position. Disinfect according to local routine procedure. Apply local or intravenous anesthesia. 5

6 THE PROCEDURE VISUALLY INSPECT THE URETHRA AND BLADDER NECK The urethra and bladder neck are inspected using an endoscope to ensure there are no unexpected abnormalities. FILL THE BLADDER WITH CONTRAST MEDIUM To ensure proper position of the needles the bladder is filled with a radio contrast agent. This enables the exact observance of the bladder (neck) contours. POSITIONING OF THE NEEDLES The needles will be positioned by inserting them in the perineum. Both endoscopic and x-ray vision are used to align the needles optimally in relation to the bladder neck. PLACING THE DEPOSITS An amount of 1.2 to 2.0 ml is injected in both the 3 and 9 o clock position to ensure proper coaptation. After the procedure the deposits will be encapsulated by connective tissue to create a long-lasting effect (figure 1). figure 1. The position of the Prolastic material after injection in a Post-Radical-Prostactectomy situation. Prolastic is a trademark of Urogyn bv. rev.0 6

7 POST-OPERATIVE PROCEDURE WHAT HAPPENS AFTER THE PROCEDURE? In case of voiding difficulties, intermittent catheterization is carried out until patients resume spontaneous voiding. Patients are discharged after residue-free voiding. If patients need to be catheterized for more than 7 days, removal of one of the deposits should be considered. This will usually solve the problem. If 6 weeks after the procedure the effect obtained is not satisfactory, extra deposits at the 5 and 7 o clock positions may be considered. PRECAUTIONS Patients should refrain from doing any heavy lifting or exercise for 4 to 6 weeks to allow for encapsulation of the implant with connective tissue. Patients should be informed that for the first few hours, and sometimes days, they may experience a bruised feeling at the injection sites. 7

8 ARE YOU INTERESTED IN BECOMING A CERTIFIED UROGYN PRACTITIONER? Urogyn offers training, free of charge, to doctors interested in conducting procedures, provided by experienced colleagues. Interested doctors will receive a training certificate after three successfully performed procedures. Primary patients or patients who have previously received treatment yet remained incontinent may be recruited for these training purposes. Doctors may train at their own hospital or at the hospital of a colleague, where they can bring their own patients. Training may also be given abroad. If you would like more information about training, or if you would like to attend a procedure performed by a trained colleague, please send us an at info@urogynbv.com. Prolastic is a trademark of Urogyn bv. rev.0 8

9 WHAT DO WE OFFER? A very cost effective procedure Free training provided by experienced colleagues Training either at your hospital or at a hospital nearby Training manual Training certificate after 3 successfully performed procedures VISIT OUR WEBSITE: CONTACT US: info@urogynbv.com For more information regarding clinical data, please go to: 9

10 Prolastic is a trademark of Urogyn bv. rev.0 PROGRESS THROUGH INNOVATION!