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  • New Urinary Prosthesis Could be Alternative to Catheterization for Some Women

    The US Food and Drug Administration (FDA) has approved a replaceable urinary prosthesis that could free women with impaired detrusor contractility (IDC) from the mobility problems associated with catheters.

    The inFlow Intraurethral Valve-Pump is a replaceable device consisting of a sterilized single-use urethral insert, an introducer, an activator, and a sizing shaft. According to a news release from the FDA, the device "draws urine out to empty the bladder and blocks urine flow when continence is desired."

    Patients with IDC are unable to spontaneously urinate, a condition that can result from stroke, spinal cord injury, diabetic neuropathy, or other neurologic disease or injury. Typically patients with IDC must use some type of catheter, and are unable to experience continence.

    The FDA reported that in testing, more than half of the 273 women who used the new device stopped using it because of leakage or discomfort. Or those who continued to use the device, 98% had post-void urine volume similar to those recorded with clean intermittent catheterization (CIC). The FDA reported that though urinary tract infection was the most significant adverse event associated with the new device, rates of infection were lower than those associated with CIC.

    After initial sizing and training by a physician, insertion and removal of the device can be performed by the patient or caregiver. Inserted components must be replaced every 29 days.

    "The inFlow device allows women with IDC to urinate, without the need to catheterize daily or be attached to a urine drainage bag," said William Maisel, deputy director for science and chief scientist in the FDA's Center for Devices and Radiological Health. "This may allow for increased mobility and the ability to be more self-sufficient."

    APTA has provided guidance to the federal Agency for Healthcare Research and Quality (.pdf) in its research efforts around urinary incontinence, and the association offers several resources to members and the public, including the APTA Section on Women's Health and the PT's Guide to Incontinence. PTs looking for evidence-based research on UI treatment can find resources at PTNow.

    Exercise Regimen Significantly Decreases Disability in Individuals With RA of the Hand

    Tailored hand exercise used as an adjunct to drug regimens can make a significant, cost-effective difference in function and quality of life for individuals with rheumatoid arthritis (RA) of the hand, according to a new randomized controlled trial from the United Kingdom (UK).

    In the Strengthening and Stretching for Rheumatoid Arthritis of the Hand study (SARAH), 438 participants representing "the population of people with rheumatoid arthritis in the UK in terms of age and sex" were divided into 2 groups, 1 receiving usual care and the other receiving usual care plus special strengthening and stretching exercises overseen by a physiotherapist or occupational therapist. More than 90% of participants in both groups had been placed on a stable regimen of disease modifying drugs (DMARDs) for at least 3 months before the study, and all continued to take the drugs.

    Results of the study were e-published ahead of print in the October 10 issue of The Lancet. Currently only the study's abstract is available for free; however, APTA members will have access to the full article in 2 months via PTNow ArticleSearch. More detailed data on the trial have been posted online.

    Researchers administered the Michigan Hand Outcome Questionnaire (MHQ) at 4 and 12 months after a 20-day baseline to both groups, and found that the exercise group's reported level of improvement was "more than double" the usual care group's ratings. The usual-care group's ratings on the 1-100 MHQ scale averaged 3.56 after 12 months, compared with the exercise group's 7.93 average.

    Other indicators were equally significant. "Changes in secondary outcomes mirrored these trends," authors write, "with significant differences in … activities of daily living, work, and satisfaction subscales, MHQ summed score, and self-efficacy." Global ratings of change in the exercise group improved for 45% of the participants, compared with 21% reporting improved ratings in the usual-care group.

    The 12-week exercise program included 7 mobility exercises and 4 strength training or endurance exercises using bands, balls, or putty, and was tailored to the individual after assessment for baseline strength, pain, and flexibility. Physiotherapists or occupational therapists conducted 6 sessions with each participant, and participants were instructed to perform the exercises daily.

    The mean cost per participant for the exercise therapy was approximately $165 higher than usual care; however, authors noted that "the costs of the intervention were small compared with the annual cost of providing drug regimens." Authors speculate that they may have actually underestimated cost-effectiveness "because the analysis was limited to a time horizon of 1 year."

    Research-related stories featured in PT in Motion News are intended to highlight a topic of interest only and do not constitute an endorsement by APTA. For synthesized research and evidence-based practice information, visit the association's PTNow website.

    Want More Research Discussion? Join the Club

    The PTNow blog's recommendation for learning more about putting evidence into practice: spend some time in a club.

    A journal club, that is. The most recent PTNow blog post features "9 Hot Tips for Running a Successful Journal Club" that can help you get started creating a lively, engaging forum for discussion of the latest in physical therapy research.

    Tips range from the practical to the aspirational, and include insight from physical therapists who have created successful clubs. Check out the tips and join the conversation by sharing your own experiences.

    Then go clubbing.