Spinal Cord Stimulation – Criteria Led Commissioning Statement

Scope

This commissioning statement refers to:

  • Sacral nerve stimulation, also termed sacral neuromodulation, which is a type of medical electrical stimulation therapy.
  • It typically involves the implantation of a programmable stimulator subcutaneously, which delivers low amplitude electrical stimulation via a lead to the sacral nerve, usually accessed via the S3 foramen.
  • In the event that the nerves and the brain are no longer communicating effectively, resulting in a bowel/bladder disorder, this type of treatment is designed to imitate a signal sent via the central nervous system.
  • One of the major nerve routes is from the brain, along the spinal cord and through the back. This is commonly referred to as the sacral area. This area controls the everyday function of the pelvic floor, urethral sphincter, bladder and bowel.
  • By stimulating the sacral nerve (located in the lower back), a signal is sent that manipulates a contraction within the pelvic floor. Over time these contractions rebuild the strength of the organs and muscles within it. This effectively alleviates all symptoms of urinary/faecal disorders, and in many cases, eliminates them completely
  • (NB In line with NICE recommendations this policy has separate eligibility criteria and care pathways for men and women).

Status

Eligibility Criteria

Women

SNS for urinary incontinence, urgency-frequency syndrome or non-obstructive urinary retention in women is not routinely commissioned unless the patient meets the following criteria:

  • Symptoms are refractory to lifestyle modification (caffeine reduction, modification of fluid intake, weight loss if BMI >30)

BMI is an established measure of weight though it is recognised that muscular people will have a higher BMI that is not thought to be a risk to health (muscle is denser than fat)

Waist circumference

  • Obesity can be measured by waist measurements but it is not yet established in UK clinical practice. NHS Choices website states individuals have a higher risk of health problems if waist size is: more than 80cm (31.5 inches)
  • Patients can be reconsidered for a referral if they have undertaken a self-managed or supervised weight reduction programme, have lost at least 5% weight and have maintained that 5% weight loss for at least 6 months
  • Symptoms are refractory to behavioural interventions: a minimum of 6 weeks of bladder retraining OR 3 months of pelvic floor muscle training (in mixed UI only, where there is some stress incontinence as well as OAB)
  • Symptoms are refractory to 4 weeks of anticholinergic medication to a maximal tolerated dose (a number of drugs may be tried in accordance with NICE CG171) [OR Mirabegron, in people for whom anticholinergic drugs are contraindicated or clinically ineffective or have unacceptable side effects (NICE TA290)]
  • The woman has been referred to secondary care, reviewed by an MDT and a diagnosis of detrusor over activity has been confirmed by urodynamic assessment
  • Symptoms are refractory to injections of Botulinum Toxin Type A into the bladder wall (only in patients willing and able to perform clean intermittent catheterisation). (NB If Botox has not been tried, the IFR should include a valid clinical explanation for this)
  • Symptoms are refractory to behavioural and lifestyle modification (diet, weight management, modification of fluid intake):
  • Bladder retraining
  • Bladder catheterisation
  • The woman has a confirmed diagnosis defined by urodynamic assessment and has been reviewed by a Urology MDT

Men

Requests for SNS from a Consultant Urologist for men with overactive bladder (OAB) caused by detrusor over activity who fulfil ALL the following criteria:

  • Symptoms are refractory to conservative management lifestyle advice, advice on fluid intake, supervised bladder training and use of containment products (pads, sheaths, etc.)
  • Symptoms are refractory to 4-6 weeks of anticholinergic medication [OR Mirabegron, in people for whom anticholinergic drugs are contraindicated or clinically ineffective, or have unacceptable side effects (NICE TA290)]
  • The man has been referred to secondary care for specialist assessment and a diagnosis of detrusor over activity has been confirmed
  • Symptoms are refractory to injections of Botulinum Toxin Type A into the bladder wall (only in patients willing and able to self-catheterise). (NB If Botox has not been tried, the IFR should include a valid clinical explanation for this)

Before a temporary SNS device is fitted, ALL prospective patients must be:

  • Able to record voiding diary data so that clinical results of the implantation can be evaluated
  • Fully informed of the risks and benefits of the procedure and, therefore, able to make an appropriate choice and consent to treatment

Before a permanent SNS device is fitted, ALL prospective patients must have been approved for and have undergone a positive trial period (2-3 weeks) of temporary stimulation resulting in a 50% or greater improvement in voiding function based on the results of a voiding diary.

SNS will not be commissioned for patients with:

  • Stress incontinence, the most common type of urinary dysfunction
  • Urinary retention due to obstruction (e.g. from benign prostatic hypertrophy, cancer, or urethral stricture)
  • Urge incontinence due to psychological or neurological conditions, such as diabetes with peripheral nerve involvement, MS, stroke or spinal cord injury (see NICE CG 148)

Spinal cord stimulation is recommended as a possible treatment for adults with chronic pain of neuropathic origin if they:

  • continue to experience chronic pain (measuring at least 50 mm on a 0-100 mm visual analogue scale) for at least 6 months despite standard treatments, and
  • have had a successful trial of spinal cord stimulation as part of an assessment by a specialist team.
  • Treatment with spinal cord stimulation should only be given after the person has been assessed by a specialist team experienced in assessing and managing people receiving treatment with spinal cord stimulation.

The CCG will not routinely fund high frequency stimulators.

Re-chargeable batteries for implantable pulse generators will be funded where this avoids the need for further surgery. It is expected that where there are different systems of equal effectiveness, the least costly system is used.

The CCG does not commission Spinal Cord Stimulation as a treatment option for adults with chronic pain of ischaemic origin.

Lifestyle Factors - Best Practice

Obesity

  • Patients with a BMI >30 should be encouraged by their Clinician to lose weight prior to surgery and signposted to appropriate support to address lifestyle factors that would improve their fitness for surgery and recovery afterwards.
  • There is a clinical balance between risk of surgical complications with obesity and the risk to delaying any surgery.
  • See Weight Management Care Pathways

Smoking

  • In line with 'Healthy Lives, Healthy People; a tobacco control plan for England', local authorities and health professionals are committed to encourage more smokers to quit.
  • Smoking remains the leading cause of preventable morbidity and premature death in England.
  • There is sufficient evidence to suggest that people who smoke have a considerably increased risk of intra- and post-operative complications such as chest infections, lung disorders, wound complications and impaired healing.
  • See Smoking Cessation Care Pathways
Please Note: The life style factors above are not a restriction to the commissioning statements unless otherwise stated

Evidence/Rationale

References

Assurance & Governance

  • This policy was developed on: 05.2017
  • This policy was approved by: Clinical Strategy Group (NK) and Clinical Cabinet (WK)
  • Date approved: 05.2017
  • Publication Date: 05.2017
  • Review Date: 04.2018
  • Ref No: PA8 - 05.2017
Any feedback or suggestions to improve this guidance should be sent to: oscaradmin@this.nhs.uk
Only the electronic version is maintained, once printed this is no longer a controlled document

 

Home > Policies > Criteria Led - Commissioning Statements > Spinal Cord Stimulation – Criteria Led Commissioning Statement