Gynaecology - Urethral bulking to treat stress urinary incontinence

Bulkamid 

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What is this procedure?

This is a procedure to treat stress urinary incontinence (leakage of urine on exercise, sneezing or straining etc).

It involves injecting a substance called bulkamid (urethral bulking agent). It is made up of 97.5% water and 2.5% polyacrylamide which has been used in cosmetic and beauty industry as dermo- filler.

It has been found to be safe by the company marketing it for this particular form of use and is currently offered in most NHS hospitals in the UK for urinary stress incontinence symptoms.

During coughing or sneezing etc, the bulking agent helps make a watertight seal around the urethra (waterpipe) and stops the urine from leaking.

It is considered to be a minor procedure and is normally done in an outpatient clinic whilst you are awake or in theatre as a day case under general anaesthesia.

Bulkamid has so far been used to treat over 50,000 women in 25 countries over 10 years. The procedure will improve symptoms in 50-70 out of 100 patients and if successful, the effect may last up to 7 years or more. If needed, the injections could be repeated.

Before the procedure

Stress incontinence can be treated by a number of ways and you are likely to be offered the following non-surgical methods before Bulkamid:
●    Incontinence pads - If your symptoms are not a significant bother, you may choose to do nothing and use pads for urine leakage
●    Supervised Pelvic floor exercises - In 70% (70 out of 100) of women supervised pelvic floor exercises can improve symptoms
●    Weight loss and giving up smoking – This has been proven to be of help
●    Vaginal devices like Contiform pessary - This small plastic device is inserted into the vagina and helps control symptoms of stress urinary incontinence, especially in situational stress incontinence symptoms (e.g. happening during exercise etc) and is currently available from your GP on NHS prescription
●    Oral medication like Duloxetine - This is an alternative non- surgical management for urinary stress incontinence and may be offered as second-line therapy if you prefer pharmacological to surgical treatment or are not suitable for surgical treatment. This medication, if taken regularly, may help with your symptoms in approximately 50% (50 out of 100 cases) but most patients experience a number of side effects and the effects stop on discontinuing the medication

What are the alternatives?

If this procedure is unsuccessful you may be offered surgery such as:
●    Colposuspension - This can be done through a cut in the lower tummy (open operation) or by keyhole surgery. It involves lifting the top of the vagina and stitching it to the pubic bone; this will help kink the urethra and prevent leakage of urine. It is a more successful procedure (85 out of 100 cases) than Bulkamid and can help treat front vaginal wall prolapse at the same time but involves general anaesthetic, small risk of damage to bowel and bladder and longer recovery time
 ●    Autologous fascial sling - This uses small amount of patient's own tissue (tummy wall or thigh) to make a hammock under the urethra to stop urine leakage, this is then passed into the tummy to help hold it in place. It is an open operation under general anaesthetic and is a longer procedure. It has a good success rate (85 out of 100) but has a higher risk of complications, such as difficulty passing urine and urgency and longer recovery time
●    Mid-urethral synthetic mesh tape (TVT/TVT-O) - The use of mesh for incontinence has been paused while extra safety measures are put in place

What happens on the day of the procedure?

We ask you to take some painkillers two hours before arriving at the clinic.

We will ask you to lie on a bed, we clean the vagina and inject local anaesthetic into your urethra. We then insert a very thin camera into the urethra and inject the bulkamid. The procedure may be uncomfortable but not particularly painful. It will take about 30 minutes. You will not have any cuts.

After the procedure, we will ask you to empty your bladder before going home. If you have difficulty in passing urine we might insert a catheter. On occasion, this might need to stay for a day or two. If this is the case, you will be allowed to go home with the catheter in place and we will bring you back to our ward for a review and removal of the catheter.

We advise you to avoid vigorous washing around and inside your vagina and intercourse for four weeks after the procedure. We also advise you to drink 1.5 - 2 litres of fluid each day and avoid irritants such as tea, coffee, fizzy drinks, alcohol, chocolate and tomatoes.
 
You should start to see the benefit soon after the procedure and we will see you in our follow up clinic in two months to check if the procedure has worked.

What are the risks?

●    Slight burning and bleeding on passing urine - for a short time after the procedure
●    Urinary infection
●    Difficulty in passing urine - In a small number of women (5%) a catheter may be needed to empty the bladder, but this is mostly short-lived
●    Urinary frequency and urgency - in a small number of women (10%) which includes needing to rush to the toilet and needing to visit the toilet more often
●    Reaction to bulkamid - this is a very rare complication
●    Anaesthetic risks - If it was decided to use general anaesthetic for the procedure, the anaesthetist will go through the risks involved with anaesthesia with you on the day

Overall, the risk of complications is small, and recovery is quick. Most patients take a couple of days off work but are back to their usual activities within 24 hours.

Quality control

As part of monitoring the outcome and complications of our procedures, we ask your permission to store securely basic information such as your name, hospital number and date of birth on a database.
 
The British Society of Urogynaecology (BSUG) can ask for this data collectively without your details to monitor the performance of our doctors.

More information

We encourage you to read up on the procedure at the following websites:
●    The manufacturer (Contura) - http://bulkamid.com/patients/
●    The British Association of Urological Surgeons (BAUS) patient information leaflet – Urethral bulking at http://www.baus.org.uk
●    International Urogynaecology Association (IUGA) patient information leaflet- Urethral Bulking at http://c.ymcdn.com
●    BSUG - https://bsug.org.uk/pages/information-for-patients/111

We also encourage you to list a few questions and what your expectations are from the procedure before coming for the procedure.
Please list any questions you may have, having read this leaflet:

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Please describe what your expectations are from surgery:

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