Current evidence on the safety and efficacy of extraurethral (non-circumferential) retropubic adjustable compression devices for stress urinary incontinence in women is inadequate in quantity and quality. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research. Find out what special arrangements mean on the NICE interventional procedures guidance page.
Clinicians wishing to insert extraurethral retropubic adjustable compression devices for stress urinary incontinence in women should:
Inform the clinical governance leads in their trusts.
Ensure that patients understand the uncertainty about the procedure's safety and efficacy and provide them with clear written information. In addition, use of NICE's information for the public is recommended.
Audit and review clinical outcomes of all patients having extraurethral retropubic adjustable compression devices for stress urinary incontinence (see section 7.2).
All adverse events involving any medical devices used in this procedure should be reported to the Medicines and Healthcare products Regulatory Agency.
Further research into this procedure should include detailed safety outcomes, long-term results and patient-reported outcome measures. NICE may update the guidance on publication of further evidence.