BULKAMID® Urethral Bulking System

Urethral bulking has become an important alternative for patients asking for minimally invasive treatments or for those who opt out of surgical procedures such as GYNECARE TVT™ Retropubic SystemTension-Free Support for Incontinence, GYNECARE TVT™ Obturator System, and GYNECARE TVT SECUR™ System. BULKAMID® and the cytoscope fulfil patient and surgeon requirements for safe and effective bulking. The added benefits of this over competitor products are as follows:

• Precision Bulking – Surgeon is fully in control of the procedure allowing optimum viewing of the urethra to target identified areas to allow for precision bulking and easy administration. It allows for full endoscopic control, which is short (12.5cm) for optimal control and is light weight making it easier to use.
• Long Lasting - The polyacrylamide used in BULKAMID® has a cross-linked structure and do not pass through biological membranes due to their large molecular size. More importantly, no enzyme or bacterium can metabolise the polyacrylamide used, which results in the implants remaining at the original site of injection.
• Non-Reabsorbable – Unlike other injection therapy products, BULKAMID® is non-reabsorbable
• Non-Toxic – Uses polyacrylamides are biodegradation thus making them non-toxic. They have been used in plastic surgery and for the manufacture of contact lenses for over 10 years.
• Molecular Structure – It has a special molecular structure that has tissue tailored viscosity and elasticity thus ‘tricking’ the body into accepting it as normal tissue and as result does not reduce hardening of surrounding tissue.
• Immediate Results – It can be administered quickly and effectively under local anaesthetic as an outpatients procedure. Results are immediate and do not require constant re-injection. For the patient it provides little to no pain and immediate, long lasting results, with no recovery time needed. Patients can get back to sports and intercourse after a week, which is substantially reduced when compared to other SUI treatment options.
• High Water Content – Contains 97.5% apyrogenic water, the highest water content of any agent of its type.
• Quicker Recovery Time - This means that there are more beds available in the hospital and in turn this will free up hospital resources meaning less expenditure is required for patient care after the surgery.

This is an alternative method to traditional methods of SUI and our GYNECARE TVT™ Retropubic SystemTension-Free Support for Incontinence, GYNECARE TVT™ Obturator System, and GYNECARE TVT SECUR™ System options. The reason for this as a product is to offer a form of therapy to those who may not be suitable for surgical procedures. It is our belief that all patients should have the right to medical care and this product does just that in providing an alternative to more traditional SUI solutions.

For clinical information about BULKAMID®, view the information below.

Recent studies have shown patient favourability and satisfaction towards bulking agents for treatment of SUI over the more traditional surgical procedures¹. The use of bulking agents through urethral injections is a minimally invasive procedure that is becoming more popular amongst patients and surgeons alike. This is primarily due to the ease of integration and the low morbidity rates^2,3.

Cross linked polyacrylamides are very stable due to a large molecular size and an inability to pas through biological membranes⁴, and are even resistant under extreme conditions to physical and chemical degregation⁵. The are also favourable due to being non-absorbable, non toxic and ease of injection.

A recent study found that the success rate in patients where a polyacrylamide hydrogel was used to treat sufferers of SUI was 87% (cured and/or improved results)⁶. The same study also found that urine leakage was decreased by 93% and the number of incontinence episodes by 87% with no injection site reactions recorded⁶. As a result, there was a significant improvement in patient’s quality of life scores in all domains with the exception of their general health perception⁶. All patients were discharged either on the day (56%) or two days after the procedure⁶.

In another study, it was found that the success rate for all patients who had received BULKAMID® as a treatment for SUI, was 67% (44% cured, 23% improved)⁷. It also found that there were low complication rates and only a re-injection rate of 31.8%⁷. These results are similar to those found for sub-urethral slings in the treatment of SUI and is definitely an option for the high risk categories where a minimally invasive procedure is better suited.

<sub>1. Lightner DJ, Itano NB, Sweat SD, et al. Injectable agents: present and future. Curr Urol Rep 2002, 3:408-413.
2. Robinson D, Anders K, Cardozo L, et al. What women want – their interpretation of the concept cure. Neurourol Urodyn, 2002; 21: 429-30.
3. Davila GW, Ghoniem GM, Kapoor DS, Contreras-Ortiz O. Pelvic floor dysfunction management practice patterns: a survey of members of the international urognecological association. Int Urogynecol J Pelvic Floor Dysfunct 2002;13:319-325.
4. King DJ, Noss RR. Toxicity of polycrylamide and acrylamide monomer. Rev Environ Health 1989; 9: 3-16.
5. McCollister DD, Hake CL, Sadek SE, Rowe VK. Toxicologic investigations of polyacrylamides. Toxicol Appl Pharmacol 1965; 7: 639-51.
6. Lose G, Mouritsen L, Bugge Beilsen J. A new bulking agent (polyacrylamide hydrogel) for treating stress urinary incontinence in women. Department of Obstretics and Gynecology, Glostrup County Hospital, University of Copenhagen, 2006.
7. Kaden A, Gusenbauer E, Lobodasch K. BULKAMID – a new treatment for female incontinence. Gynaecology and Obstretics Clinic, DRK Krankenhaus Chemnitz-Rabenstein.</sub>

The following brochure provides information for patients about BULKAMID®

The benefits highlighted above discuss why BULKAMID® is a suitable alternative to more traditional procedures. However, the BULKAMID® Cystoscope allows for the following product capabilities.

Capabilities Explanation

Disposable
The lightweight cystoscope is the only patented disposable, female cystoscope in the world.

Optical Control
Prior to the needle tips emergence from the guidance system, full optical control allows the surgeon to identify and place exact insertions around the circumference of the urethra without extraction.

Minimises Tissue Damage
The 23G needle, which has been tailor, made for use with the injector allows for maximum control thus reducing the risk of tissue damage or puncture.

Compatible
The Cystoscope has been designed for integration and compatibility with standard equipment available in most hospitals worldwide.