Optilume Balloon Dilatation for Anterior Urethral Strictures

What is an anterior urethral stricture?

An anterior urethral stricture is a narrowing of the urethra caused by scarring, which obstructs the flow of urine. It is typically identified during a cystoscopy and is located near the beginning of the urethral pipe which brings the urine out of the bladder. Common symptoms include:

• Hesitancy when starting to urinate
• Weak or irregular urinary stream
• Straining to urinate
• Painful urination
• Urinary tract infections
• Bleeding during urination

Consultation

Following diagnosis, after your cystoscopy, you will have a consultation with a specialist to discuss your treatment options, as follows:

• Traditional treatments which are urethral dilatation and/or visual internal urethrotomy
• Optilume balloon dilatation
• Urethroplasty

During this consultation, you will discuss potential side effects of the treatment with your doctor and sign a consent form before scheduling the procedure. You will also receive comprehensive information about the treatment.

What is Optilume Balloon Dilatation?

Optilume is a minimally invasive treatment for urethral strictures. It provides immediate relief and works by preventing the regrowth of scar tissue, which commonly recurs after dilations or direct visual internal urethrotomy. The last 2 are traditional treatments for urethral strictures.

Treatment with Optilume Balloon Dilatation

Optilume consists of a small, cylindrical balloon coated with medication, called Paclitaxel which is a medicine for cancer treatment. It is designed to both dilate the urethra and reduce the likelihood of stricture recurrence. 

This procedure can be performed under:

• general anaesthesia in an operating theatre or
• local urethral anaesthesia in an outpatient setting

Benefits of Optilume Balloon Dilatation

• It is minimally invasive and generally well tolerated
• It offers immediate improvement in urination symptoms
• You won’t need to use a catheter yourself to keep your urethra open

Note: Optilume is National Institute for Health and Care Excellence (NICE) approved only for recurrent anterior urethral strictures.

Side Effects

Common side effects – for 1 in 10 patients to 1 in 20 patients:

• Blood in the urine which can be on and off for several days.
• Discomfort during urination.
• Urinary tract infection.

Less common complications – for 1 in 20 patients to 1 in 50 patients:

• Complete urinary blockage.
• Infection of organs connected to the bladder such as kidneys, testicles .

Rare complications – for less than 1 in 100 patients: 

• Urethral dissection or perforation.
• Erectile dysfunction.

Potential complications – safety has not yet been confirmed.

• Medication (paclitaxel) related fertility issues.
• Safety of pregnancy, if trying to father a child for up to 6 months after the treatment with Optilume.

Important Safety Information

During Optilume treatment, the medication Paclitaxel works directly on the urethra. This means only a very small amount enters the bloodstream, so the rest of your body is unlikely to be affected. However, potential risks to your fertility and your partner’s future pregnancies cannot be entirely ruled out. 

The effects of Optilume treatment on fertility and sexual function have been studied in the ROBUST III trial:

• Drug concentrations in urine peak immediately after the procedure and reduce to undetectable levels within 30 days.
• Paclitaxel levels in semen were minimal right after the procedure and undetectable after 3 months.
• No adverse events of de novo erectile or ejaculatory dysfunction were reported. 
• No significant changes in sperm concentration or total sperm count were observed from baseline to 6 months.
• There are ongoing trials to prove the safety of Optilume treatment to semen characteristics
  and pregnancy.

Recommendations

Abstain from sexual activity or use barrier contraception such as condoms for 30 days after your treatment.

If your partner/wife is of childbearing age use highly effective contraception and avoid fathering children for at least 6 months after your treatment.

On the Day of Treatment

If the procedure is performed under local anaesthesia, you will attend Westwood Park or the Day Case Unit at St Luke’s Hospital, as an outpatient. The treatment will be carried out in a quiet, private environment by experienced staff.

If performed under general or spinal anaesthesia, you will need to attend a pre-assessment appointment to make sure it is safe for you to have an anaesthetic. You will then receive instructions regarding when you will need to stop eating ahead of the treatment, what time you should arrive and the location.

You will be admitted to either Ward 20 at the Bradford Royal Infirmary or the Day Case Unit at St Luke’s Hospital. The nursing team will admit you and the surgical team will confirm your consent for the procedure and answer any remaining questions.

If you have concerns or wish to reconsider the procedure, please discuss them with the medical team before proceeding.

After the Operation

A catheter will be in place for 5–8 days.

You will return to Westwood Park Hospital for catheter removal.

After removal, you will be asked to drink water and urinate 3 times. You will have an ultrasound to check for any residual urine in your bladder. Please allow half a day for this process.

You will be followed up in clinic at:

• 3 months
• 12 months
• 24 months

If You Experience Problems Following Your Procedure

Please, contact the Urology Secretary on telephone number: 01274 276015. Working days/hours: Monday to Friday between 8.00am and 3.00pm, except bank holidays.

Outside working hours, please attend the Emergency Department at the Bradford Royal Infirmary.