Two TV ads for the Innovo device, seen in August, October and November 2018:
a. The first ad featured a woman attending an exercise class. A voice-over stated, "Bladder weakness? You could say goodbye to it. Less looking out for loos, or scrambling for pads. Exercise? No sweat. Laugh in the face of sneezing. Cough without crossed legs. You can, you know. I'm ready for everything and out for drinks with the girls. Innovo’s multipath technology is non-invasive, comfortable and strengthens your pelvic floor." An animation showed a garment that wrapped around the thighs. On-screen text stated, "Clinically proven. Non-invasive. Comfortable. Strengthens pelvic floor". The voice-over stated, "Target the cause of bladder weakness, not just the symptoms. Restore your confidence at restorethefloor.com/innovo." On-screen text stated, "93% of users found a significant improvement after 4 weeks*". Smaller superimposed text stated "*Based on 19 people using Innovo for 30 minutes five days a week".
b. The second ad showed two women talking and holding glasses of water. A voice-over stated, “I laughed so hard … I didn’t pee myself.” A woman was shown eating ice cream and holding shopping bags. A voice-over stated, “I might not have much self-control ... but I have much more bladder control.” A woman was shown sitting in a swimming pool. A voice-over stated, “I’m breaking my pad habit … are you?” A woman was shown sitting on a sofa reading and using the device. A voice-over stated, “No one likes having leaks or wearing pads.” On screen, text stated, “Only 30 mins a day 5 days a week”. The voice-over stated, “Innovo shorts could change your life in just four weeks.” An animation showed a device in a pair of shorts. On screen, text stated, "Clinically proven. Non-invasive. Strengthens your pelvic floor. Easy to use". The voice-over stated, “The clever technology in these shorts is non-invasive, strengthens your pelvic floor, and is super easy to use. Target the cause of bladder weakness, not just the symptoms.” On screen, text stated “93% of users found a significant improvement after just 4 weeks*”. Smaller text at the bottom of the screen stated, “Based on 19 people using Innovo gel pads only for 30 minutes five days a week”. The voice-over stated, “Enjoy life more. Take back control. Search Innovo.”
Four complainants challenged whether the efficacy claims that the product was clinically proven to strengthen the pelvic floor and treat bladder weakness were misleading and could be substantiated.
Atlantic Therapeutics Group Ltd said that they had consciously chosen not to use the words “treat” or “treatment” in the ad. They had made a distinction to talk about “improvement”, in line with their evidence that they believed showed a dramatic improvement, but not overstating that the product was a treatment or cure. They had portrayed some of the scenarios cited in research, in which consumers wished to reclaim the confidence to go about their life, and this was reflected in the language used. Atlantic Therapeutics referred to a CAP Advice Online entry on “Health: Electrical stimulation devices and incontinence”. They believed that their advertising claims were in line with that advice.
Atlantic Therapeutics provided CE documentation, a clinical evaluation report, an equivalence report, a pilot study, two randomised controlled trials (RCTs) and two posters. They said that the endpoints used to measure results in their studies reflected those listed in the FDA guidance for clinical investigations of devices indicated for treatment of urinary incontinence. Clearcast said that at the time the ad was cleared, they were supplied with the CE documentation and the pilot study. Based on the evidence provided, their medical expert was satisfied that the claims “93% of users found significant improvement at 4 weeks” and “clinically proven non-invasive, comfortable, strengthens your pelvic floor” were supported. Clearcast said that the ad referred to “targeting” bladder weakness and talked about an improvement of the condition. There was no suggestion that the device would eliminate the problem completely. The claims from the beginning of the ad were set up in a conditional tone, e.g. “you could”, and referred to the less frequent need to visit the toilet or looking for pads, giving women the confidence to carry on with their lives, meet friends and attend exercise classes.
Ad (a) stated “Bladder weakness? You could say goodbye to it” and referred to potential everyday benefits consumers might gain if they did not have to worry about leaks. The ad also stated “clinically proven”, “strengthens your pelvic floor”, “target the cause of bladder weakness” and “93% of users found a significant improvement after 4 weeks”.
Ad (b) made similar claims and also stated “Innovo shorts could change your life in just four weeks”.
The ASA considered that consumers were likely to understand from both ads that the Innovo product was effective at strengthening the pelvic floor, improving incontinence and reducing leaks as a result. While we noted Atlantic Therapeutics’ comments that the ads used conditional language and did not explicitly claim to “treat” or “cure” incontinence, we did not consider that this detracted from the overall impression that the product could significantly reduce or eliminate users’ symptoms. In the absence of more detailed information, consumers would understand that the claims related generally to incontinence resulting from different causes.
Under the BCAP Code, medical claims could be made for CE-marked medical devices provided they complied with other requirements of the Codes, including those relating to substantiation. Atlantic Therapeutics provided documentation demonstrating that the Innovo Type 207 device was a CE-marked class IIa medical device. CE certification in itself did not constitute evidence for medical efficacy claims, and advertisers needed to ensure that they held adequate evidence for such claims. We took expert advice on the clinical studies and evidence of equivalence submitted by Atlantic Therapeutics. The Innovo device was a multipurpose muscle stimulation unit capable of delivering neuromuscular electrical stimulation (NMES) with the intention of treating stress and urgency urinary incontinence (SUI and UUI respectively). The aim of any NMES device in treating SUI was to improve the performance, bulk and strength of the pelvic floor muscles so that the urethra was compressed and/or the bladder neck raised in order to prevent urine leakage. UUI was present in patients who had an overactive bladder. While the mechanism was not well understood, it was thought that it may involve overstimulation of the bladder muscle by nerves going to the bladder from the spinal cord. Unlike SUI, UUI was not thought to be caused by weakness of the pelvic floor muscles.
The more traditional way of improving the strength of pelvic floor muscles was by teaching women to contract their pelvic floor muscles themselves, known as pelvic floor muscle training (PFMT). However, some women were unable to perform a voluntary contraction, hence the use of NMES which directly stimulated the muscles to contract. The traditional method for delivery of NMES was via vaginal or rectal electrode probes. By contrast, Innovo delivered electrical stimulation via up to eight external electrodes placed on the skin surface on either side of the pelvis, onto the legs and buttocks. No rationale was provided for how surface NMES might treat UUI, given that it was not caused by pelvic floor muscle weakness. The CE documentation related to an earlier variant of the product, shown in ad (a), in which the electrodes were applied using a garment that wrapped around the upper thighs.
Ad (b) featured an updated version in which the electrodes were contained in a pair of shorts, which provided improved ease of use. We understood that the only differences between the two versions related to the method by which the electrodes were held in place and the use of a different electrolyte spray to ensure they made similar or better skin contact. We therefore accepted that the two products were equivalent and the CE documentation also applied to the device being advertised. We noted that the CAP Advice Online entry on electrical stimulation devices and incontinence pertained to devices using a vaginal probe, while the Innovo device used an external method of delivery. Furthermore, expert advice in the current case had provided an updated overview of the evidence for transvaginal devices. The clinical evaluation report cited a number of studies in a variety of populations. Several of these used unspecified types of electrical stimulation and/or had unclear study designs, so it was not possible to conclude anything from them. Further studies involved forms of electrical stimulation that differed from the method used by the Innovo product, and were therefore not relevant. One study cited measured ultrasound-diagnosed bladder base elevation to assess pelvic floor contractions in healthy women, comparing a vaginal probe with external electrodes embedded in a garment. However, as the participants were asymptomatic, it was unclear whether the improvement achieved was clinically significant.
The report also summarised some additional studies which were provided to the ASA in full and assessed below. A study on five healthy women compared the earlier version of Innovo (wrap garment) with the Innovo shorts. Both devices were reported to achieve elevation of the base of the bladder; however, it was unclear whether there was any relationship between this movement and measureable clinical changes in women who actually had incontinence.
A pilot study on the Innovo wrap garment enrolled 19 women with SUI who had failed a six-week pelvic floor muscle training programme. We understood that a six-week programme of pelvic floor muscle training would be considered too short to make a significant impact on reducing SUI, with NICE guidance recommending at least three months. Therefore, women could have continued to practice their exercises and seen benefits from them during the course of the trial. The primary outcome was defined as a greater than 50% reduction in pad weight following a standardised one-minute stress test at one hour post bladder filling protocol at 12 weeks compared to baseline. While we understood that pad weight tests could be useful for quantifying urine loss and assessing the severity of a patient’s condition at baseline, 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. We did not consider that significant improvements in pad weight results alone were likely to be sufficient to substantiate the claims.
In any case, notwithstanding the types of measurement used in this study, it was not possible to attribute any changes to the intervention, because there was no control. The aim of a pilot study was to assess the feasibility of a much larger definitive study, rather than to measure efficacy, and in addition to that a population size of 19 participants was underpowered to assess the effectiveness of the device. A double-blind RCT tested the effectiveness of a device with a similar mode of delivery as the Innovo device in women diagnosed with SUI. As above, the participants had undertaken a six-week course of PFMT. The control group was treated with a modified version of the device intended to produce a strong sensory response in the skin but little activation of the pelvic floor muscles (an inactive sham device). The study aimed to enrol 140 women but was not completed, meaning it was underpowered to detect any difference between the groups, and there was a high dropout rate. One of the endpoints measured was the pad weight test, the limitations of which are discussed above. The study also measured pelvic floor strength using the Modified Oxford Score, as well as self-reported outcomes. We understood that improvement in pelvic floor muscle strength was not the same as reduction in incontinence, and changes in this objective measure did not necessarily indicate that the intervention had had a meaningful effect on women’s experience of incontinence. Furthermore, there was also an improvement in the control (inactive sham device) group, with no significant differences identified between the groups.
As a result, it was not possible to attribute any increase in strength to the effect of the test device. We understood that the most relevant measures for measuring changes in urinary incontinence were women’s subjective assessments of improvement and its effect on their quality of life.
The RCT assessed quality of life using the Incontinence Quality of Life Questionnaire (I-QOL) and Kings Health Questionnaire (KHQ). However, while there was an improvement from baseline in the treatment group, there was also an improvement in the control group, with no statistical significance between the outcomes for the two groups. Therefore it was not possible to attribute any changes to the effect of the device. A single-blind RCT enrolled 180 women with SUI who had previously tried and failed PFMT, though the duration of the programme was not made clear. They were randomised to complete either a 12-week treatment programme with a skin electrode system (the same method of delivery as the Innovo device), or a vaginal probe system. The primary objective was to demonstrate equivalence between the products in terms of the number of women who had at least a 50% reduction in pad weight compared to baseline at 12 weeks. As described above, we understood that improvements in pad weight were unlikely, on their own, to sufficiently support claims for efficacy.
The trial also measured participants’ subjective perceptions of improvement using the Patient Global Impression of Improvement scale, with 70.7% of subjects in the skin electrode group stating there was an improvement in their symptoms compared with 63% of subjects in the vaginal probe group. However, the trial was considered to be too small to demonstrate comparable efficacy by an independent statistician. Furthermore, we noted that the overall evidence for the efficacy of vaginal probe devices for incontinence was weak, as described further below. Therefore, a study demonstrating equivalence to that type of device was unlikely to be sufficient to support efficacy claims for the Innovo in the absence of significant between-group differences in well-designed studies using an appropriate control and outcome measurements. We took into account two relevant Cochrane reviews, which we understood represented the best available summary of the literature on electrical stimulation devices for incontinence. The first review of 56 RCTs on women treated for SUI with a mix of electrical stimulation regimes suggested that electrical stimulation may be better than no active or sham treatment, but was no better, and may be worse, than the most common traditional treatment ? PFMT. Overall, the quality of the evidence was too low to provide reliable results. A second Cochrane review on electrical stimulation for overactive bladder/UUI identified 63 RCTs.
All the trials aimed to stimulate or suppress the nerve supply to the bladder through various forms of electrical stimulation. The authors concluded that electrical stimulation showed promise in treating overactive bladder. However, the low quality of the evidence base overall meant that it was not possible to have full confidence in the conclusions. Furthermore, as the mechanism of electrical stimulation for overactive bladder/UUI was thought to act via the nerve supply to the bladder, we considered it was unclear how the Innovo device, which passed a current across the pelvis, could affect the condition. Taking into account the full body of evidence provided by the advertiser, we did not consider it substantiated the impression that viewers were likely to take from the two ads ? that is, that the Innovo device could strengthen the pelvic floor and reduce or eliminate symptoms of incontinence. We concluded that the ads were misleading and breached the Code. Ads (a) and (b) breached BCAP Code rules
Advertisements must not materially mislead or be likely to do so.
Broadcasters must hold documentary evidence to prove claims that the audience is likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation.
If they are necessary for the assessment of claims, broadcasters must, before the advertisement is broadcast, obtain generally accepted scientific evidence and independent expert advice.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, the VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease. (Medicines, medical devices, treatments and health).
The ads must not be broadcast again in the forms complained about. We told Atlantic Therapeutics Group Ltd not to state or imply that the Innovo device could strengthen the pelvic floor or treat incontinence unless they held sufficient evidence to substantiate their claims. For example, they must not use the claims “Bladder weakness? You could say goodbye to it”, “strengthens your pelvic floor”, “target the cause of bladder weakness”, “93% of users found a significant improvement after 4 weeks”, or claims similar to them, or otherwise imply that the product could strengthen the pelvic floor or reduce or eliminate symptoms of incontinence.