Scientific evidence for pelvic floor devices

Te Brummelstroete G1, Loohuis A M M2, Wessels N J2, Van Summeren J2, Westers H2, Blanker M H2

Research Type

Clinical

Abstract Category

Continence Care Products / Devices / Technologies

Abstract 568
Open Discussion ePosters
Scientific Open Discussion ePoster Session 28
Friday 31st August 2018
13:20 - 13:25 (ePoster Station 8)
Exhibition Hall
Incontinence New Devices Stress Urinary Incontinence Pelvic Floor
1. Martini Hospital, dept of Urology, Groningen, The Netherlands, 2. University Medical Center Groningen, dept of general practice, Groningen, The Netherlands
Presenter
G

Gerhard Te Brummelstroete

Links

Poster

Abstract

Hypothesis / aims of study
The scientific field of pelvic floor problems is emerging. Next to this, numerous devices are available for caregivers and their patients with pelvic floor problems. Following various discussions with abstract presenters at previous scientific meetings, it seemed that for some of these devices the scientific evidence was lacking. In this study, we evaluated the scientific background for pelvic floor devices, presented during scientific meetings, either as an abstract, or on the exhibition floor. We aim to provide an overview of the scientific evidence for pelvic floor devices.
Study design, materials and methods
We manually searched all abstracts of the scientific meetings of the International Continence Society (ICS), International UroGynaecology Association (IUGA), European Association of Urologists (EAU) and American Urological Association (AUA), held in 2016 and 2017. Abstract search was performed in duplicate. Additionally, authors visited the exhibition floor at ICS 2017, looking for devices that were presented. Manufacturers were asked for additional (scientific) information on the devices.
For all eligible devices, we search for the following information, on the manufacturers’ website, or in manufacturers’ brochures: Type of device, Condition (urinary incontinence, pelvic organ prolapse, other), Type of diagnostic, Type of intervention, Availability for healthcare providers and/or patients, price. To find the scientific backgrounds of each device, we have searched both the Pubmed and Embase databases in March 2018. For this, we entered the names of authors of included abstracts, as well as the name of each device. We will present anonymous results.
Results
From 8,930 abstracts (2,121 ICS, 558 IUGA, 2,019 EAU, and 4,232 AUA) we selected six eligible devices, listed in Table 1. At the exhibition floor we found four additional devices. No devices were found in abstracts presented at the AUA meetings. ICS meetings were the most common source to find abstracts on pelvic floor devices: data on eight devices were presented at the annual meetings. In Table 1 we summarized the information of the included devices.
Main conditions described were stress UI (five devices), UI (two devices), or other (three devices). Eight devices were meant as treatment devices, whereas the two other devices were both diagnostic and therapeutic devices.
Scientific publications 
For six devices (A, C, D, E, H, J), we found no full text publications. Two of these devices (D, H) were not yet available on the market. Data from the first studies was presented at ICS 2017. For three other devices, first presentations at scientific meetings were held in 2016 (A, C), and 2011 (J). No publications were available after that, nor was information available from manufacturers websites. Device E was presented at the exhibition floor of the ICS. No full text publications, nor data from other studies was available for this device. References included on the manufacturers website did not provide additional studies published in journals.
For device B, results from a pilot study on 40 patients had been presented at a scientific meeting in 2012, and were consequently published full-text in 2015. Notably, the manufacturers website includes references to studies in which it is unclear if the device itself was the topic of the study.
For device D, a diagnostic validation study including 10 patients with voiding dysfunction was presented at ICS 2017, and published as full text paper in 2017 (ePub ahead of print). Notably, this device is presented as a novel device, but this device shows similarities with a device for which 19 publications were found. These publications focused on pelvic floor muscle strength measurements, but not on therapeutic goals.
For device F, we found two publications. One case report and one case study. Presentations in 2017 included a RCT with 47 women and a RCT with 51 women, from which it is unclear if these are two separate trials, or two reports of one ongoing trial.
For device G (presented at the exhibition floor at ICS 2017, without abstracts detected in our search), we found a phase III trial comparing the device to no treatment in 55 women, published in 2012. No further publications followed this paper.
For device I we found a diagnostic validation study including 229 healthy volunteers, and a RCT with 58 OAB patients comparing toilet behavior and lifestyle instructions with pelvic floor muscle training supported with the device.
Interpretation of results
We found ten devices for pelvic floor problems. This mainly included devices intended as treatment of (stress) UI. Nearly all devices were presented at ICS meetings; none were presented at the AUA meeting. Despite the lack of any peer-reviewed publications on the validity and usability, five devices were commercially available for patients. 
For other devices, some publications were found. This included pilot studies, and a phase III trial. For one device aiming at both diagnosis and treatment, only a small diagnostic study was published. For this device, scientific evidence seemed to be based on earlier versions of the device, or on general knowledge about kegel devices. For another device, we found detailed descriptions, published in peer-reviewed journals of both the diagnostic as well as the treatment aim of the device. This device is available only for caregivers.
Our findings are in line with a Cochrane review, published in 2014, concluding that the place of mechanical devices in the management of urinary incontinence remains in question, due to a lack of evidence from proper RCTs (1). We acknowledge that publishing in peer-reviewed journals may be time-consuming, and we are unaware of submitted manuscripts. However, we noticed that most abstracts did not include validation studies of the devices, or reliable clinical studies. Both are needed before good clinical care can be delivered. When comparing these findings to the introduction of new (classes of) drugs, we see a large discrepancy. Without proper studies, new drugs are not approved.
Concluding message
Although various devices are available for patients with pelvic floor dysfunction – either via caregivers, or directly purchased to patients – the evidence base for these devices is narrow. The ICS annual meetings appeared to be the most important venue to report on these issues.
Figure 1
References
  1. Lipp A, Shaw C, Glavind K. Mechanical devices for urinary incontinence in women. Cochrane Database Syst Rev. 2014 Dec 17;(12):CD001756. doi: 10.1002/14651858.CD001756.pub6.
Disclosures
Funding No funding Clinical Trial No Subjects None