The Health Information and Quality Authority (HIQA) has completed a rapid health technology assessment (HTA) on the use of vesicostomy buttons in children. These devices are used as a way of managing urine storage and bladder emptying problems in a very small number of children with certain complex health conditions, such as spina bifida.
This cohort of children are at an increased risk of urinary problems, including kidney damage, and may have limited options to manage these problems. This rapid HTA was requested by the Minister for Health.

A vesicostomy is a surgical procedure that creates a small opening on the abdomen to allow urine to drain from the bladder. The opening can be left open (meaning urine will drain freely) or can be closed using a vesicostomy button to allow urine to be drained intermittently. A vesicostomy button is a small medical-grade silicone device inserted into the opening and is a modification of the gastrostomy button, originally designed for feeding into the stomach. It was first repurposed for urinary use in 1996 and is now used more widely in children, both internationally and in Ireland.

HIQA found that there are two vesicostomy button devices currently in use, with both devices being used ‘off label’ for the purpose of bladder emptying. The use of ‘off-label’ devices, that is, for a purpose other than the one they were originally approved for, is permitted and commonplace in clinical practice. ‘Off-label’ use often occurs where alternatives are limited, particularly in medical specialties such as surgery and paediatrics.

HIQA’s rapid HTA found that there was limited published research on the use of vesicostomy buttons in children. Fourteen studies were identified across several countries, including a total of 244 children. Most children were around five years old when the device was inserted. No serious safety concerns were identified in the literature over the last 30 years of vesicostomy button use in clinical practice, and, generally, positive outcomes were reported.

Commenting on the report, HIQA’s Deputy Chief Executive and Director of Health Technology Assessment, Dr Máirín Ryan, said:

“In our assessment, we found that while there is little research into the use of vesicostomy buttons, there were no serious safety concerns noted in the studies we examined and, overall, children and carers reported satisfaction with the device. Compared with standard catheters for urine drainage, vesicostomy buttons are discreet, sit close to the skin, and can make everyday activities such as sports, playing and swimming more comfortable for children. The assessment did note the occurrence of complications such as leakage, infections and skin reactions. However, it is hard to determine if these complications occur more often than with standard catheters.”

Dr Ryan continued:

“The current evidence base suggests that vesicostomy buttons may be a useful option for certain children, particularly when standard catheterisation is difficult, painful or not possible.”

ENDS

Further information:

Caoimhe O’Connell, Communications Manager caoconnell@hiqa.ie 

Notes for Editor:

• The Health Information and Quality Authority (HIQA) has today published the following:
  • Protocol for a rapid HTA on the use of vesicostomy buttons in children
  • Rapid HTA on the use of vesicostomy buttons in children
• A wide variety of complex clinical conditions can result in problems with urine storage and bladder emptying in children. However, these conditions are generally rare or uncommon. Some examples of these conditions include neurogenic bladder (for example in children with spina bifida), anorectal malformations and posterior urethral valves.
• From 2018 to 2026 a total of 26 vesicostomy buttons were placed in patients at Children’s Health Ireland (CHI) hospitals.
• Any ‘off-label’ use of medical devices merits consideration of controlled risk management processes, clear governance structures and fully informed consent in accordance with legislation and the best available evidence. Patient and carer information leaflets should provide accessible information to support safe and effective care and a clear explanation of what ‘off-label’ means in this context.
• Other ways to manage bladder emptying problems include intermittent catheterisation, where a small tube is inserted into the bladder several times a day to drain urine and then removed, and suprapubic catheterisation, where a tube is placed into the bladder through a small opening in the lower abdomen and left in place to allow urine to drain continuously.

About HIQA

The Health Information and Quality Authority (HIQA) is the independent body that promotes safety and quality in the provision of health and social care services in Ireland.

Through its regulation, standard setting and evidence to inform decision-making functions, HIQA supports health and social care services to consistently deliver excellent standards of care and the best possible health and social care outcomes for all.