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Guest Editorial

Guest Editorial: Surfing an Ocean of Change

December 2012

  Despite the challenges of cost and other resource constraints, advancements in continence care continue to bring new options through technology, research, and the innovative spirit of American ingenuity. New medications for overactive bladder (OAB), new devices that assess and treat fecal and urinary incontinence, more absorbent products, and most importantly, ongoing education and research lend hope to persons coping with incontinence and those who provide and champion their care. A Google search using the phrase incontinence technology yielded the following recent advancements.

Medications

  The OWM November 2012 “Continence Coach” discussed an alternative to antimuscarinic medications that work by blocking receptors that cause bladder contractions that initiate the urge to urinate. A new drug, mirabegron, acts on beta-3 adrenergic receptors, with the effect of increasing bladder capacity. It has been US Food and Drug Administration (FDA)- approved and should be available before the new year.

Assessment Devices

  The FDA has approved Minneapolis-based Medspira’s mcompassanorectal manometry device that can evaluate pelvic floor function in persons with constipation or fecal incontinence. The system comprises three components: a disposable catheter, mobile tablet PC, and wireless portable manometer. Even inexperienced users can master the device, and results are displayed on the tablet PC in real time. The fully secure data can be emailed to specialists for review and interpretation.

  Another assessment device, SIM® (Simavita [Australia]) automates manual continence assessments. Over a 72-hour or 7-day assessment period, continence event data, along with caregiver observations, are logged to provide accurate details of the resident’s continence profile and to develop an evidence-based continence care plan. The continence goals involve continence aid selection, appropriate toileting schedule, continence aid changes, and other aids.

Procedural Options

  The Renessa System (Novasys Medical) technology is comprised of a small generator that provides low radiofrequency energy and a single-use disposable transurethal probe that delivers the energy directly to the proximal urethral region. Following treatment by a urological professional, the natural collagen in the body’s tissue becomes firmer over time, increasing the bladder’s ability to resist leaks. The procedure requires no incisions or general anesthesia, and no foreign materials or implants are left behind.

  With regard to preventive procedures, a number of articles describe increasing use of robotic prostate surgery to limit damage and lower the risk for postop incontinence.

Urinary Control

  The J Clamp (Jackson Medical Products) is a male incontinence control device that eliminates leaking by compressing the urethra. An adjustable barrel applies pressure to the underside of the penis.

  For women with urinary incontinence, new disposable “tampon-like” electrostimulation technology (Pelviva®, Femeda) used along with appropriate exercise was shown in a 12-week randomized, controlled trial to produce significantly better outcomes in terms of global impressions of severity and improvement (secondary) completed at recruitment, after 4 weeks of unsupervised exercise, and immediately post-treatment, than unsupervised exercise alone (P = 0.014).

  Also available for both urinary incontinence assessment and treatment: uControl sEMG (bio-medical.com), a battery-operated, shirt pocket-size sEMG monitor.

Absorbent Products

  Wellness Briefs® (Unique Wellness) utilize space-age technology used by the NASA scientists to provide three-layer protection similar to MAGs provided to astronauts during the space trips. The innermost layer retains any type of fluid and lets the topmost layer in touch with the skin completely dry, ensuring a leak-proof experience for the user. It also eliminates any chance of urine exposure or odor.

  Well-known Attends Healthcare products have increased absorbency and added unscented options to some of their care products. Absorbent products manufactured in Italy from organic cotton (Corman) also are now available in the US retail market. Available through health food supermarkets, retail drug chains, and by mail order, these products are especially well-suited to sensitive skin easily irritated by bleach and other chemicals used routinely in standard disposable products made from nonwovens and synthetic films.

  Also available: Sensors that assess wetness of incontinence pads and alert caregivers to the need for intervention.

Education

  The Innovating for Continence Conference Series. This international, biennial multi-disciplinary conference is for engineers, physicians, nurses, people with incontinence and their caregivers, academics, industry executives, and those with a passion for increased development of creative and efficacious products for the management of incontinence. The meetings attract speakers from a wide range of disciplines and are organized and hosted by The Simon Foundation for Continence (Chicago, IL). The conference series is made possible through support from individuals and industry sponsors.

  BOTOX® training. Touch of Life Technologies (ToLTech) developed a virtual reality-based cystoscopy simulator to train and evaluate urologists on the procedure of injecting onabotulinumtoxin A (BOTOX®, Allergan) into the detrusor muscle of the bladder to treat urinary urgency, frequency, and urinary urgency incontinence in adults with OAB due to neurologic condition, or neurogenic bladder.

Research

  Shamilyan et al,1 under the auspices of the Agency for Healthcare Research and Quality, examined and synthesized published evidence regarding the diagnosis and management of urinary incontinence in adult women. The authors’ primary foci were adult women in ambulatory care settings and nonsurgical approaches to care. The report also addressed the controversial role of urodynamic testing to provide insight on its appropriate use. Highlights include:

  Women saw clinical value even in 50% reduction of urinary incontinence frequency; they reported improved quality of life and clinical success only when they experienced more than 70% reduction in incontinence episode frequency; and more than 60% with persistent urgency, stress, or mixed urinary incontinence were completely satisfied if treatment provided a 70% reduction of incontinence episodes.

  With regard to pharmacological treatments, anticholinergic medications were more effective than placebo in achieving continence and improving urinary incontinence, but with low benefits; antimuscarinic drugs were beneficial; and prescription drug compliance rates are low, while discontinuation due to side effects is common. Nonpharmacological treatments provide clinical benefit with a low risk of adverse effects.

  This comprehensive, insightful report is an important contribution to the incontinence literature and is intended to help clinicians, consumers, and policymakers make clinical recommendations and informed decisions.

  In ongoing research, Beech Tree Labs, Inc. completed a successful Phase 2a clinical evaluation of its novel therapeutic agent, UISH001, for treating urinary incontinence. This FDA-authorized study was a multisite, 67-patient, placebo-controlled trial. Patients were treated for 4 weeks with sublingual drops of the test product or placebo. Results showed all test parameters to be in favor of the treatment population, with the most significant (P = 0.039) reflecting a decrease in the use of pads for leakage. The test group showed placebo-level side effects. Results from the Cleveland Clinic’s research on rats complemented these outcomes.

  The Medical College of Wisconsin has begun a clinical study of InTone®, a new, FDA-approved medical device that treats female urinary incontinence. The 12-week study will evaluate the effectiveness of InTone in women with stress incontinence, urge incontinence, or mixed (stress AND urge) incontinence.

  The change in mindset from the inevitability to the treatability of incontinence, along with the stimulation of learning about the oceans of opportunities in caring and treatment, excite me and keep me in this field. We can anticipate ongoing innovation in managing incontinence — ships of hope we can share with our patients.

 This article was not subject to the Ostomy Wound Management peer-review process.

1. Shamliyan T, Wyman J, Kane RL. Nonsurgical treatments for urinary incontinence in adult women: diagnosis and comparative effectiveness. Comparative Effectiveness Review No. 36. (Prepared by the University of Minnesota Evidence-based Practice Center under Contract No. HHSA 290-2007-10064-I.) AHRQ Publication No. 11(12)-EHC074-EF. Rockville, MD. Agency for Healthcare Research and Quality. March 2012. Available at: www.effectivehealthcare.ahrq.gov/reports/final.cfm. Accessed November 14, 2012.

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