WHAT IS IT?
Bulkamid Hydrogel is a transparent polyacrylamide gel. It does not migrate and is not broken down in the body. There are no allergies. It has been used in plastic surgery and to make contact lenses for over 10 years.
HOW IS IT INJECTED?
A telescope is inserted into the urethra (the tube from the bladder). Using this telescope a needle is inserted into the lining of the urethra, just below the bladder. First local anaesthetic is injected and then the Bulkamid. This narrows the urethra, reducing urine leakage. It can be performed under local or general anaesthesia or sedation and takes about 10 minutes.
WHAT IS THIS PROCEDURE USED FOR?
It is used for the treatment of stress incontinence. Its advantage is that it is a simple low risk procedure that can be done as a day case with immediate return to normal activities. This treatment doesn’t work in everyone. It will fail to improve about 20% - 30% of patients. It may be the best choice in women who for various reasons have either an increased risk or do not wish to undergo more invasive surgery or a general anaesthetic. It may suit some women who have only a mild degree of incontinence despite more conservative treatments like pelvic floor exercises. It is can be used for men who are incontinent following prostate surgery. It may be a good option for people who are unable to take work or time to recover because of other commitments and are looking for a treatment option with a quick return to usual activities. It may also be a good option in patients who have difficulty emptying their bladder or who are at risk of bladder emptying problems as this procedure has a much lower risk of other urinary retention problems.
HOW MANY INJECTION TREATMENT SESSIONS ARE NEEDED?
It usually takes an average of 1-2 treatments in women, and up to 4 in men, to achieve best results. After the first injection it is not uncommon for initial improvement to wear off and some incontinence to return. It may not be until after the second injection that a more durable result is achieved. A three month period is required between each injection session if more than one treatment is required.
HOW LIKELY IS IT TO WORK?
Early studies show at an average of 2 years after treatment 60% of people are still significantly improved but only 40% are completely dry. Results are generally better in women than men. Longer studies are not available. If effect wears off repeat injection can be performed.
WHAT IF IT DOESN’T WORK?
The treatment can be repeated or other surgical options can be pursued. Having had the Bulkamid injection does not jeopardise your ability to go on to have other treatments.
WHAT ARE THE OTHER TREATMENT OPTIONS?
Bladder training and pelvic floor exercises, dietary and lifestyle modifications or other surgical procedures your doctor can discuss with you.
HOW LONG DOES IT TAKE?
The procedure takes about 10 minutes but your will usually be asked to arrive about one hour prior to allow for your hospital admission and preparation time. You will then be asked to stay after the procedure until you have passed a good volume of urine. Allow at least 3-4 hours in total at the hospital.
WHAT PREPARATION IS REQUIRED?
No special preparation is required before arrival if the procedure is usually performed under local anaesthesia as a day procedure. You do not need to fast unless having sedation or general anaesthesia. On arrival you will be asked to empty your bladder before the procedure and you will be given a dose of an antibiotic to minimise the risk of a urine infection. You will be asked to change into a hospital gown. In the operating theatre the genital region will be washed with an antiseptic and then a local anaesthetic lubricating jelly will be applied to make the passage of the telescope more comfortable.
WHAT CAN I EXPECT AFTERWARDS?
The first few times you pass your urine after the procedure you may see a small amount of blood, and you may experience a burning sensation. These symptoms are short lived and usually resolve within 24 hours. It is possible for a small proportion of the Bulkamid to escape from the injection site and be passed in the urine as a clear gel. Any improvement in incontinence is immediate. After the procedure you need to stay in hospital until you have passed urine, usually 2-3 hours. Most patients have no difficulty but some patients may have difficulty emptying their bladder because of swelling of the tissues. This is usually short lived, less than 48 hours. Uncommonly a small catheter needs to be passed either intermittently or left in place, usually for less than 48 hours, until normal emptying returns. Following assessment of the effects of the first injection session, a second injection session may be arranged. This is performed after three months to allow the first lot of Bulkamid to become incorporated into your tissues. Earlier second injections can result in some of the first lot leaking out. Remember two or more injections may be needed to benefit fully. If you have had no improvement after two injections sessions the treatment has failed and alternative treatments should be considered.
WHAT ARE THE POTENTIAL SIDE-EFFECTS AND COMPLICATIONS?
These are all uncommon or rare, occurring in the minority of patients.
There is a small risk of getting a urine infection in the few days following this procedure; 0.5- 4% risk. A single dose of an antibiotic tablet is given with the procedure to minimise this risk. If you experience a frequent and urgent need to urinate, pain or burning when urinating, blood in the urine or the urine becomes cloudy or smelly you should arrange for a urine test for infection and you may be given antibiotic medication. Other signs of infection could be generally feeling unwell, headaches, and a temperature.
This is a sudden compelling desire to pass urine, which is difficult to defer. This may occur as a new symptom in a few patients; about 10%. This usually settles in 24-48 hours and rarely requires short term treatment with medications.
This is the inability to pass urine afterwards, requiring a catheter to be passed; 1-8%. This is usually short term lasting < 24 hours. It is very uncommon for urinary retention to persist. In such a case further surgery to dilate the urethra or remove the Bulkamid implant may be required.
Seeing blood in your urine
This occurs in only a few patients; 5%. It is usually only a small amount of blood and resolves within 24 hours.
Pain at Injection site following the procedure is uncommon; 1%
Bladder spasms or cramping pains; <1%
Infection of the urethra, vagina, or epididymis, or abscess formation <1%
Worsening of your incontinence – very rare
It is often not possible to warn patients of every possible risk or potential complication with surgery especially if very rare. Yet it is important that you are aware of what risks are involved, especially the more common ones. This information is not meant to alarm you but allow you to make an informed consent to have surgery. It is very rare but unfortunately some patients can suffer complications and end up worse off as a result of their surgery.
Version: V2, July 2013