Health: Electrical stimulation devices and incontinence


INSIGHT
Published
Mar 4th '20
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Urinary incontinence can affect men and women throughout all stages of their lives but particularly women after pregnancy, childbirth and during the menopause. Urinary incontinence is defined as “the involuntary loss of urine that is a social or hygienic problem”. Loss of control of the pelvic floor muscles, for example after childbirth, can lead to this involuntary loss of urine.

 

Urinary incontinence is frequently embarrassing and has led to medical intervention from many sources. The Department of Health has recommended that conservative methods, for example a regimen of pelvic floor exercises, should always be tried first. If those measures are unsuccessful, surgical procedures could be desirable.

 

  • What are electrical stimulation devices for incontinence?

If a woman is unable to contract her pelvic floor muscles, if the muscles are very weak or she has poor muscle awareness, a battery-operated electrical muscle stimulation device may be used to help identify those muscles.

 

The devices are typically intended are intended to train the pelvic floor muscles by producing a series of electrically induced contractions, to improve strength and function.

 

Such devices sometimes use a vaginal probe which are operated by a hand-held control unit.

 

  • Are the products medical devices?

Committee of Advertising Practice (CAP) understands that the Medicines and Healthcare products Regulatory Agency (MHRA) are likely to consider that devices which are presented in ads as treatments for urinary incontinence are medical devices and as such, marketers will need to hold an appropriate CE classification for that device.

 

Marketers of internal devices (vaginal probe) are urged to seek advice from the MHRA on Medical Devices in to ensure that the device is appropriately CE Marked irrespective of the advertising claims.

 

  • What claims are likely to be acceptable or unacceptable?

Marketers of devices are reminded that if they make any objective claims in their ads, they would need hold documentary evidence in support (rule 12.1).  Where those claims are medicinal (i.e. claims to “treat” or “help with” symptoms associated with urinary incontinence) it is likely that the Advertising Standards Authority (ASA) would expect that evidence to be in the form of clinical trial evidence.

 

In 2019 the ASA considered a TV ad which included the claims “Bladder weakness? You could say goodbye to it”, “strengthens your pelvic floor”, “target the cause of bladder weakness” and “93% of users found a significant improvement after 4 weeks” in relation to a non-invasive medical devices which involved 8 external electrodes placed on the skin and which delivered.  A large amount of clinical evidence was supplied including those on devices with different application of electrodes or were on non-symptomatic patient groups.  These studies were not considered capable of supporting the specific claims in the ad.  Other studies were found to be flawed in their design or did not show significant differences between the products and placebo groups.  Some studies relied upon the difference in the weight in urinary pads between the product and placebo groups, which was considered not to be a robust measure of efficacy because they were recognised to give variable results. In addition, improvements in pad weight test results did not necessarily correspond with patients’ own perceptions of improvement.  Despite the large amount of evidence submitted, the ASA concluded that the specific claims in the ad had not been substantiated and were therefore misleading (Atlantic Therapeutics, 26 February 2020).

 

  • What about conditions or symptoms for which medical supervision should be sought?

Ads which reference medical conditions for which medical supervision should be sought could have the effect of discouraging essential medical treatment, unless the device will be used in treatment under the supervision of a suitably qualified health professional (rule 12.2).

 

Specific references to conditions in which urinary incontinence is known to be associated, such as the symptoms of the menopause, potentially risks discouraging essential medical treatment.

 

Source: CAP

 

Note: This advice is given by the CAP Executive about non-broadcast advertising. It does not constitute legal advice. It does not bind CAP, CAP advisory panels or the ASA.

 

CAP’s AdviceOnline entries provide guidance on interpreting the UK Code of Non-broadcast Advertising and Direct & Promotional Marketing.

 

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