Botulinum toxin type A injections into the urethral sphincter for idiopathic chronic non-obstructive urinary retention

  • HealthTech guidance
  • HTG685
  • Published: 
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1 Recommendations

1.1

For people with idiopathic chronic non-obstructive urinary retention caused by external urethral sphincter dysfunction (also known as Fowler's syndrome in younger women and people with female anatomy, primary disorder of urethral sphincter relaxation or high-tone non-relaxing urethral sphincter), botulinum toxin type A injections into the urethral sphincter should only be used with special arrangements for clinical governance, consent, and audit or research. Find out what special arrangements mean on the NICE guidance page.

1.2

Clinicians wanting to do botulinum toxin type A injections into the urethral sphincter for idiopathic chronic non-obstructive urinary retention because of external urethral sphincter dysfunction should:

  • Inform the clinical governance leads in their healthcare organisation.

  • Ensure that people and their families understand the procedure's safety and efficacy, and any uncertainties about these.

  • Take account of NICE's advice on shared decision making, including NICE's information for the public.

  • Audit and review clinical outcomes of everyone having the procedure. The main efficacy and safety outcomes identified in this guidance can be entered into NICE's audit tool (for use at local discretion).

  • Discuss the outcomes of the procedure during their annual appraisal to reflect, learn and improve.

1.3

Healthcare organisations should:

  • Ensure systems are in place that support clinicians to collect and report data on outcomes and safety for everyone having this procedure.

  • Regularly review data on outcomes and safety for this procedure.

1.4

Patient selection should be done by a multidisciplinary team.

1.5

The procedure should only be done in a specialist centre by clinicians with expertise in managing the condition.

More research is needed

1.6

For people with idiopathic chronic non-obstructive urinary retention from all other causes, botulinum toxin type A injections into the urethral sphincter should be used only in research. Find out what only in research means on the NICE guidance page.

What research is needed

1.7

Further research should ideally be in the form of randomised controlled trials. Details of patient selection, the procedure and long-term outcomes should be reported.

Why the committee made these recommendations

External urethral sphincter dysfunction is rare, and evidence from observational studies suggests that the procedure may improve symptoms. But there are uncertainties about how well it works and how safe it is in the long term. So, it should only be used with special arrangements for external urethral dysfunction.

Evidence on the safety and efficacy of botulinum toxin type A injections into the urethral sphincter for idiopathic chronic non-obstructive urinary retention from all other causes is inadequate in quality and quantity. So, it should only be used in research when there are other causes.