Professional

Frequently Asked Questions

What is Bulkamid® injection therapy?

Bulkamid® injection therapy is used to treat Stress Urinary Incontinence.

Bulkamid® is made from a homogeneous polyacrylamide hydrogel. Our gel contains 2.5% cross-linked polyacrylamide and 97.5% apyrogenic water. Bulkamid® is sterile, stable and biologically inactive.

Bulkamid® is non-toxic, resistant to biodegradation, and cannot pass through biological membranes because of the large molecular size of the cross-linked polyacrylamide.

It is transparent, odourless, pH neutral and insoluble in all known solvents.

How soon do results appear?

The results obtained with Bulkamid® injection therapy are immediate, but some patients may need re-injection.

How does the injection take place?

A Bulkamid® Cystoscope has been specially developed to solve the problems that have dogged other injection techniques until present. The cystoscope gives the physician full control and enables a panoramic view of the urethra. This means that the cystoscope can be swivelled to precisely the correct position for each - normally 3 - bulking points.

Does it hurt?

Hardly, as the patient is locally anaesthetised.

How long do the patient has to be off work?

The Bulkamid® urethral bulking procedure can be carried out as an out-patient procedure with two days sick-leave. Some people take a few days off, other return to work immediately.

How long do results last?

Bulkamid® urethral bulking agent is non-resorbable and does not disappear, so the effect of the injection of Bulkamid® urethral bulking agent is long-lasting. Our clinical study with duration of 12 months show stable results so majority will need one injection only. In few patients a re-injection may be necessary.

Why is Bulkamid® urethral bulking agent long-lasting?

The polyacrylamide used in Bulkamid® urethral bulking agent is chemically non-resorbable; its cross-linked structure and big molecular size mean it cannot pass biological membranes. Moreover, no enzyme or bacterium can metabolise the polyacrylamide used. As a result the implants remain at the site of injection.

Does Bulkamid® urethral bulking agent move from the site of injection?

Bulkamid® urethral bulking agent is migration resistant and becomes an integrated part of the body's own tissue.

What other uses do polyacrylamides have?

• Polyacrylamides are used in medical products such as soft contact lenses and implant materials.
• Polyacrylamides are used in the production of drinking water. They are used as a flocculent and coagulant to remove particles from the water.
• Polyacrylamides are used to wash fruits for peeling as well as certain vegetables.
• Polyacrylamides are also used as a flocculent in the production of cane sugar.
• Polyacrylamides are also used in the cosmetics industry (e.g. hair colouring products, creams, and lotions) and in paper production.

Where is Bulkamid® urethral bulking agent made?

Bulkamid® urethral bulking agent is produced in Copenhagen, Denmark, by the healthcare company Ferrosan A/S.

Is Bulkamid® urethral bulking agent CE and FDA approved?

Bulkamid® urethral bulking agent has a CE 0543 mark. The CE-mark indicates that Bulkamid® urethral bulking agent meets the requirements formulated in the European Medical Devices Directive 93/42/EEC. The 0543 number indicates the Notified Body.

Bulkamid® urethral bulking agent is currently not approved by the FDA.