Urethral Bulking is a thick, permanent gel used to treat women who have stress urinary incontinence due to weak pelvic floor (urethral sphincter) muscles. It is a single-use kit that consists of sterile syringes filled with the Bulkamid gel, a rotatable sheath, and injection needles.
What is Stress Urinary Incontinence?
Stress Urinary Incontinence (SUI) is the unintentional passing of urine during activity or exertion, such as
during coughing, laughing, or exercise.
- It is caused by a weakness of the pelvic floor muscles, preventing the urethra from closing fully when sudden pressure is put on the bladder.
- SUI afflicts women of all ages, with childbirth as one of the main contributing factors.
- SUI can have a significant impact on daily life, affecting activities, relationships and emotional well-being.
The majority of women with SUI are suffering in silence. Of the women who have sought medical treatment, many are offered conservative therapy or opt for no treatment due to limitations of legacy bulking agents and reluctance to undergo a sling procedure.
Axonics, maker of Bulamid, has a significant opportunity to engage with physicians and increase awareness among millions of women suffering in silence that there is an SUI treatment that is clinically proven, safe, and aligns with patients’ preference for minimally invasive solutions.
What is Urethral Bulking?
Urethral bulking to treat urinary incontinence involves injecting material (such as collagen) around the urethra. This may be done to build up the thickness of the wall of the urethra so it seals tightly when you hold back urine.
Most bulking materials are injected around the urethra just outside the muscle of the urethra at the bladder outlet. Injecting the bulking material may be done through the urethra or, in women, through the vagina. Needle placement is guided by the use of a cystoscope inserted into the urethra.
Urethral bulking procedures are usually done under local anesthesia or with sedation. But they may require a general or regional anesthesia. Using local anesthesia or sedation allows the person to stand up after an injection to find out if continence has been achieved. If continence has not been restored, another injection may be done.
This treatment may help, but the effect may wear off over time. It is common to need more treatments.
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Who is more suitable for Urethral Bulking?
- Women who are not fit enough for surgery and anesthesia
- Women who haven’t completed their family
- Women who do not wish to undergo surgery for stress incontinence or for whom conventional surgery has not been fully effective
- Women whose stress incontinence is due mainly to a deficiency in the sphincter muscle surrounding the urethra
Urethral Bulking Procedure
The procedure can be performed under local anesthetic in the clinic or under a general anesthetic in the operating room. Your doctor will discuss which option is best for you. The bulking agent is injected around the urethra just below the neck of the bladder via a cystoscope or specially designed syringe. No incisions, cuts, or stitches in the vagina or abdomen are required for this procedure.
Risks of Urethral Bulking
- Anesthetic risks. These will be discussed with you by the anesthetist.
- Bleeding and infection. These are risks of any gynecological surgery. Your doctor may give you a dose of antibiotics prior to the bulking injection. Let your doctor know if you are taking aspirin or blood thinning agents.
- Pain on passing urine. You may notice some initial burning or stinging on passing urine. This will usually settle within 24-48 hours. If you develop urinary frequency, offensive or unusual smelling urine and pain on urination you may have a bladder infection in which case you should call your doctor for advice.
- Difficulty emptying the bladder. Less than 10% of women temporarily have difficulty emptying the bladder completely, requiring a catheter. There are no known long-term risks of difficulty emptying.
- Need for a repeat bulking procedure. A “top-up” of the bulking agent is sometimes needed to optimally control SUI symptoms. The effect of the bulking agent can also sometimes reduce with time, requiring a second injection.
Additional risks can include movement of the bulking material from where it was injected, hypersensitivity/allergy, abscess formation (local infection), or granuloma (a small cyst-like structure where the bulking material was injected). These risks are uncommon, and your doctor will discuss whether they apply to the specific type of bulking agent you will be having.