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Minimally invasive treatment for

female stress urinary incontinence.

Exclusively for the French market.

Bulkamid is a urethral filler, composed of 97.5% water and 2.5% Polyacrylamide. Bulkamid is injected into the tissues of your urethra. The effect of Bulkamid is obtained by the volume of gel filling the deficiency of the urethra. A treatment for female stress urinary incontinence without incision.

What is stress urinary incontinence?

Stress urinary incontinence is the involuntary loss of urine during physical activity or exertion, such as coughing, laughing, or exercising. It is the result of muscle weakness in the pelvic floor.

Stress urinary incontinence is a common condition that affects one in three women. This inconvenience can have a significant impact on quality of life, as it affects activities, relationships, and emotional well-being. SUI can occur at any stage of life: postpartum pelvic floor imbalances, pelvic surgeries and age increase the risk of incontinence.

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How can stress urinary incontinence be treated?

Stress urinary incontinence is treated in several ways. Your doctor will inform and advise you on the different options available and help you make the best decision for you. These can be:

Pelvic floor muscle strengthening

Pelvic floor exercises, often called “Kegel exercises,” will most often be one of the first options recommended by your doctor. These exercises improve bladder and urethral support.

Fillers

Urethral filling is the injection of a filling agent, such as Bulkamid, into the wall of the urethra in order to add volume (“fill”) to the tissues. This procedure is less invasive than surgery. A Filling Agent strengthens the closing mechanism of the urethra, and allows better control of urine when you cough, laugh, exercise or change position. A filler does not completely close the urethra: the urethra always opens to allow urination.

When not to use Bulkamid?

Bulkamid should not be used in patients with urinary tract infection.

What are the risks associated with the Bulkamid procedure?

Over 70,000 women with urinary incontinence have been treated with Bulkamid in 25 countries over the past 15 years. During this period, a low number of complications or adverse effects were reported and there were no long-term complications reported.

However, as with any treatment, complications can occur. These complications may include: temporary pain during and immediately after the procedure (anesthesia will help with this), some blood in the urine, delayed urination, painful urination, and/or urinary tract infection. These complications are usually temporary and disappear within a few days. In very rare cases, patients may experience difficulty urinating normally, and may require the temporary use of a catheter to empty the bladder. This is usually resolved within 24 hours. As with any treatment, there is a possibility that you may not derive any benefit from treatment with Bulkamid. Also, if you have another form of urinary incontinence, such as Urge Incontinence, or if your incontinence is getting worse, Bulkamid may not be an effective treatment for you.

What are the benefits of the Bulkamid procedure?

The majority of women treated with Bulkamid report dryness or improvement, and many notice this improvement immediately after the procedure. Although the most desired outcome of treatment is no leakage at all, many women consider treatment to have been effective if a significant decrease in the volume and frequency of urinary leakage is such that they can return to most of their daily activities.

If following treatment with Bulkamid your symptoms are not significantly improved, an additional injection of Bulkamid may be offered to complete the treatment. It is recommended to wait at least 4 weeks after the 1st treatment, before proceeding with an additional injection. Speak to your doctor about possible additional treatment if you still suffer from urinary leakage after your first treatment.

The result of your treatment with Bulkamid is that you will no longer have involuntary urinary leakage or at least you will have significantly fewer episodes of urinary leakage. In the Bulkamid clinical studies, women were asked their feelings about the effectiveness of this treatment 12 months after the 1st injection. More than 3⁄4 of the women reported that their incontinence was cured or improved and approximately 2/3 of the women were dry. Bulkamid clinical studies have also shown that the effect should last for several years. The data available to date show that most of the women treated report efficacy for another 7 years after treatment.

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