Clinical studies, tests, and trials measuring the effectiveness of medical device and medication in treating urinary incontinence.

Medical Devices

INCONTROL MEDICAL – InTone/ApexM

CITATION:
InTone: a novel pelvic floor rehabilitation device for urinary incontinence

Guralnick, M.L., Kelly, H., Engelke, H. et al. Int Urogynecol J (2015) 26: 99. doi:10.1007/s00192-

CONCLUSIONS:
Twelve weeks of InTone usage resulted in significant objective and subjective reductions in UI. Device usability was very good. 90% effective in reducing the number of daily incontinence episodes.

NOTES:
ApexM is the over-the-counter version of InTone (InTone is available only through doctor prescription) that utilizes the same technology and electro stimulation algorithm. Cost for an ApexM device from InControl Medical ranges from $249 – $299.

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MEDTRONIC INTERSTIM

CITATION:
Results of a prospective, multicenter study evaluating quality of life, safety, and efficacy of sacral neuromodulation at twelve months in subjects with symptoms of overactive bladder

Noblett, K., Siegel, S., Mangel, J., Griebling, T. L., Sutherland, S. E., Bird, E. T., Comiter, C., Culkin, D., Bennett, J., Zylstra, S., Kan, F. and Berg, K. C. (2016). Neurourol. Urodynam., 35: 166–251. doi:10.1002/nau.22707

CONCLUSIONS:
This multicenter study shows SNM is safe and effective and results in improved outcomes through 12 months in subjects with OAB symptoms, without requiring failure of all medications.

NOTES:
The Interstim device comes at cost. Requiring surgical implantation, the device itself costs in the range of $20,000 – $30,000, not including doctor, anesthesiology, or other hospital-related costs. 

There are also post-operation costs as the battery which runs the implanted device has a relatively short shelf-life (@5-7 years on average).

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Medications

MIRABEGRON (MYRBETRIQ)

CITATION:
Mirabegron: a review of recent data and its prospects in the management of overactive bladder

Emilio Sacco, Riccardo Bientinesi, Therapeutic Advances in Urology ,Vol 4, Issue 6, pp. 315 – 316.
First published date: September-04-2012

CONCLUSIONS:
Treatment with the 50 mg dose achieved the primary efficacy objectives, although it resulted only in a reduction of 0.55 micturitions per 16 h and 0.40 incontinence episodes per 16 h compared with placebo.

NOTES:
Some critical safety issues are still to be clarified with the use of Myrbetriq. The increase in blood pressure and heart rate, mainly observed in phase I studies, pharmacokinetic interaction with other drugs, and the increased incidence of new malignant events observed with the 100 mg dose have raised concerns. Further clinical and long-term studies are especially needed for a thorough representation of the safety profile.

Anticholinergic Therapy (PILLS) vs. OnabotulinumtoxinA (BOTOX)

CITATION:
Anticholinergic Therapy vs. OnabotulinumtoxinA for Urgency Urinary Incontinence

Anthony G. Visco, M.D., Linda Brubaker, M.D., Holly E. Richter, Ph.D., M.D., Ingrid Nygaard, M.D., et al, for the Pelvic Floor Disorders Network
New England Journal of Medicine 2012; 367:1803-1813, November 8, 2012DOI: 10.1056/NEJMoa1208872

CONCLUSIONS:
Oral anticholinergic therapy and onabotulinumtoxinA by injection were associated with similar reductions in the frequency of daily episodes of urgency urinary incontinence.

RESULTS:
The mean reduction in episodes of urgency urinary incontinence per day over the course of 6 months, from a baseline average of 5.0 per day, was 3.4 in the anticholinergic group and 3.3 in the onabotulinumtoxinA group (P=0.81). Complete resolution of urgency urinary incontinence was reported by 13% and 27% of the women, respectively (P=0.003).

NOTES:
With full resolution numbers ranging from 13%-27% after 6 months of continued use, it appears the overall effectiveness is quite limited for both oral medications and Botox injections.

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