Results and Benefits

The Results

prostaCare, the company that developed the prostaFix device, has done a feasibility study with 16 patients and onto its first regulatory clincial evaluation study in humans with 40 patients to secure European CE Mark approval.

The feasibility study showed very good results: two-thirds of patients reported experiencing lasting relief and did not experience any side effects.

• Quick and lasting symptomatic relief: significantly improved BPH symptom score
• Minimal side effects: preserves sexual function & continence, no device-related serious AE, much less pain.
• Excellent tolerability: well-tolerated & painless (31% patients had no increase in VAS score & avg 1.2)
• Improved QOL: 67% improvement in QOL score at 6-month
• Fast treatment time: 24-minute procedure at optimal dose
• Average necrotic region: 2.0cm x 1.2cm x 2cm at 1week

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The Benefits

Because the prostaFix treatment is so mild and non-invasive, it avoids the distressing side-effects of other current treatments. These include incontinence, erection problems, pain and bleeding (after surgery).

prostaFix is a long-lasting treatment. The effects last for years. And symptom relief is quick – the direct-current treated tissue gradually and painlessly abrades over about a week.

The procedure is minimally invasive, involving just the insertion of a catheter that is removed at the end of the 30-minute treatment session, which means post-procedure effects are minor. These are a small amount of inflammation and some tenderness, but healing is rapid and there is no scarring.

Because the procedure is so safe it can be done in the doctor’s office. And, because it is so precisely controlled (the balloon ‘anchor’ ensures precise targeting of tissue, and the control unit controls the current dosage) nearby tissues and nerves aren’t damaged.

prostaFix is superior to other comparable in-office procedures which use steam or a super-hot needle and are painful and also hard for the doctor to do.

The clinical feasibility study

This involved 16 patients with BPH who took part in a human feasibility trial to test the effectiveness and safety of the prostaFix procedure. They were followed up for 12 months afterwards and reported quick and lasting symptom relief with minimal side-effects, such as post-procedure inflammation and tenderness.