Assessment of vesicostomy buttons found little international research, but no serious safety concerns were highlighted
Specialist devices to manage urine storage and bladder emptying problems in children with complex health conditions, such as spina bifida, have led to general positive outcomes, but research into their use is limited, a review has found.
On foot of a request from the Minister for Health, the Health Information and Quality Authority (HIQA) has completed a rapid health technology assessment (HTA) on the use of vesicostomy buttons in children.
It found that there is relatively little research into the use of the devices for this purpose. However, studies that exist show that vesicostomy buttons can pose a more convenient and less painful alternative to catheters for certain children.
“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,” said HIQA’s Deputy Chief Executive Dr Máirín Ryan.
“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 added: “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.”
Children with complex conditions, including spina bifida, are at an increased risk of urinary problems, including kidney damage, and may have limited options to manage these problems.
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. There are two vesicostomy button devices currently in use, with both devices being used ‘off label’ for the purpose of bladder-emptying.
In its review HIQA found 14 studies involving 244 children and young people who had undergone a button vesicostomy procedure.
Patients in these research studies ranged in age from newborn babies to 19 years, but most were about five years old when they had the vesicostomy button inserted.
“Various adverse events were reported by the included case series, including UTIs, local infections and tissue reactions, and leakage from the vesicostomy site,” the assessment said.
“However, no serious safety concerns were noted. Patient or parent satisfaction was reported in nine case series, however only one study formally evaluated quality of life using a validated tool.
“Overall, the reported patient and parent satisfaction was positive and the vesicostomy buttons appeared to be generally well tolerated by patients.”
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