Bulkamid is a urethral bulking agent, consisting of 97.5% water and 2.5% polyacrylamide. Bulkamid is injected into the soft tissue of your urethra using a syringe. Bulkamid achieves its bulking effect by the volume of the gel injected; other bulking agents achieve their bulking effect by a combination of the micro particles themselves and the body’s own reaction to the particles.
Bulkamid is indicated for use as a urethral bulking agent for the treatment of female urinary incontinence, where stress incontinence is the primary type of incontinence (as some people have urge incontinence).
Bulkamid Urethral Bulking System must not be used in patients suffering from acute urinary tract infection.
Bulkamid should not be used in male patients.
Contura conducted a Bulkamid clinical study at 33 medical centers in the United States and Canada. Two hundred and twenty eight (228) women with stress urinary incontinence received Bulkamid and were followed for 12 months after the initial treatment; 46.9% (107 of 228) of these women reported their symptoms to have improved by at least half (50%), whilst three quarters (75%) of women reported dryness or improvement in their symptoms after Bulkamid treatment. The level of improvement was similar to another FDA-approved bulking agent that was also used in the study, specifically the Allergan Inc. Contigen Bard Collagen Implant.
In the clinical study, once women had received the initial injection of Bulkamid, they were offered up to two additional injections if their symptoms were still present. Seventy-seven (77) percent (176 of 228) of women treated with Bulkamid had additional injections of Bulkamid.
The most common side effects (adverse events) reported by Bulkamid clinical study patients are listed in the table below. Most of these adverse events were temporary. One patient treated with Bulkamid experienced a serious adverse event (blood in urine) that was thought to be related to the bulking procedure but not to the Bulkamid gel.
Most common side effects reported in the Bulkamid Clinical Study
|Pain at implantation||13 in 100|
|Acute urinary retention||6 in 100|
|Urinary tract/bladder infection||4 in 100|
|Blood in urine (hematuria/transient hematuria)||2 in 100|
|Painful urination (dysuria)||1 in 100|
|Strong desire to urinate, but no incontinence episodes (urgency)||1 in 100|
|Urge incontinence||1 in 100|
|Worsening urinary incontinence||1 in 100|
|Vaginal infection||1 in 100|
Over 70,000 women with stress urinary incontinence in 25 countries over 10 years have been treated with Bulkamid. During that time, a low number of complications have been reported and there have been no reported long-term complications. However, as with any invasive procedure, complications may occur.
Complications can include pain related to the procedure, a small amount of blood in the urine, delayed urination, painful urination, and/or urinary tract infection. These complications are usually temporary and normally resolve within a few days. In very rare cases patients may experience difficulties to normally pass urine and may require the use of a disposable catheter to catheterize themselves to empty the bladder a few times each day until the bladder starts to empty on its own again.
Although not seen in the Bulkamid clinical study, following side effects have occurred in women who received other urethral bulking agents: blood vessel blockage (embolism/vascular occlusion), skin redness (erythema), loss of bulking agent material through the injection site (excreted material), movement of bulking agent material to a different location inside the body (migration), inflammation causing a growth of tissue (granuloma), inability to completely empty the bladder (outlet obstruction), loss of urethral tissue over the implant site (erosion), and frequent urination.
There is a possibility that you may not experience any benefit from Bulkamid treatment. This could happen if Bulkamid is placed too deeply in the tissue, thereby creating poor bulking around the urethra. Also, if you have a different type of incontinence, such as urge incontinence or if your incontinence condition worsens, Bulkamid may not be an effective treatment for you.
The majority of women treated with Bulkamid report dryness or improvement in their symptoms, with many seeing that improvement as soon as they leave the doctor’s office, hospital or clinic. While being free from unwanted leakage is the most desired outcome of treatment, many women consider a successful treatment to be a decrease in the amount and frequency of urine leakage due to stress urinary incontinence.
If relief from your symptoms is not sufficient following treatment with Bulkamid, an additional injection (a “top-up” injection) can be given to help achieve satisfactory results. Contura recommends that you wait at least 4 weeks between treatments to realize the full benefit of the first treatment. Talk to your doctor about an additional treatment if you continue to experience urine leakage after the first treatment.
The benefit of Bulkamid treatment is that you could be free from unwanted urinary leakage or have fewer episodes of urinary leakage. In the Bulkamid clinical study women were asked how effective they felt their treatment was 12 months after their initial injection. Over three quarters of women reported that their incontinence was either “dry, much improved or improved” and approximately half of women reported zero stress urinary incontinence episodes.
The Bulkamid procedure is minimally invasive and typically takes about 10-15 minutes to perform. The procedure usually takes place in an outpatient clinic and you will normally be able to go home on the same day.
Prior to the procedure, your doctor will discuss whether you should have a local or general anesthetic to reduce any discomfort associated with the procedure. Most patients will undergo a Bulkamid procedure under local anesthetic and will feel no more than a slight scratch as the needle enters the urethral wall.
Your doctor may prescribe an antibiotic to reduce the risk of infection.
During the procedure a cystoscope (a small instrument with a viewing camera used by the doctor) will be inserted into the urethra, which allows the procedure to be completed under constant visualization. Three or four deposits of Bulkamid (1.5 – 2 mL total volume, equivalent to slightly less than half a teaspoon) will be placed into the urethral tissue until the opposite walls are gently touching in the center of the urethral opening. The cystoscope is removed after the injection is complete and your treatment is finished.
After the procedure, your ability to empty your bladder will be checked prior to leaving the clinic to ensure no further assistance is required.
If you cannot pass urine, a catheter may be required for a short period (normally less than 24 hours but in very rare cases it may take days to weeks) to allow emptying of the bladder. This is an uncommon complication occurring in only 6 out of every 100 patients. Once at home, the majority of patients return to normal activities within 24 hours, depending on their doctor’s advice.
If you need to undergo a surgical procedure in the future, especially a dental procedure, there is a risk of infection developing near where the Bulkamid was placed. This is due to the possibility of bacteria moving and settling in to the implant, which is the case with many other medical implants. So if you require a surgical or dental procedure in the future, please tell the treating physician that you have a permanent implant and discuss the need for possible antibiotic therapy with them.
A variety of materials are commonly and safely used in medicine. Their safety and effectiveness depend on many factors which include quantity, intended use, placement as well as their physico-chemical characteristics and manufacturing process. Each of these parameters has a significant effect on safety and performance. Polyacrylamides differ considerably in their chemical and physical structure and hence their use cannot be commonly considered as the same.
Bulkamid is a hydrogel consisting of 97.5% water and 2.5% cross linked polyacrylamide. Manufactured at our facilities in Copenhagen, the process has been established over 20 years and inspections from international regulatory authorities take place regularly to ensure compliance and robust standards are maintained.
Safety in the body has been established through comprehensive biocompatibility and clinical testing in accordance with international and national regulations (EU and US) that are relevant for this class of device. Bulkamid is a Class III device in the US that is subject to a rigorous premarket clinical investigation and regulatory approval pathway. In comparison mesh products for urinary incontinence surgery are Class II devices in the US and undergo a less rigorous regulatory process.
Given the standards and testing that has been in place and the clinical experience over the last two decades, Bulkamid’s safety has been well established.
For a detailed list of biocompatibility testing requirements, see FDA guidance document Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”.