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The In-Flow is replaceable urinary prosthesis that is designed to normalize toileting in women with chronic voiding dysfunction. The device simulates normal physio-logic function in two ways: 1) its internal pump simulates normal bladder function by fully evacuating urine even in patients with hypotonic/acontractile (atonic) bladder, and 2) its valve simulates normal sphincter function by closing at the control of the patient in order to block the flow of urine for patients with refractory urinary incontinence (UI).

The In-Flow provides safety and effectiveness comparable to clean intermittent catheterization (CIC), but with added convenience and personal dignity. Its benefits include:

- Lowest UTI rate of any indwelling device - equal to or better than the UTI rate for intermittent catheters 
- Highest quality of life 
- Internal pump virtually eliminates post-void residual 
- No serious or lasting adverse events associated with even long-term use 
- Easily removed at any time, including by patients 

The In-Flow employs an entirely new approach to bladder drainage. Unlike all urinary catheters, which rely on gravity to passively drain the bladder, the In-Flow has an internal pump that spins at 10,000 RPM and actively empties urine. As a result, voiding is more natural. The technology involved is considerable (key design aspects are patented worldwide) and results in significant advantages::

1. Reduced risk of infection
Its IDE study (n=273) found that the UTI rate for the In-Flow was the same or better than for CIC. This finding is quite remarkable, as any indwelling device would be expected to have a far higher rate than CIC, which contacts tissue only intermittently (24/7 vs. minutes/day). In contrast, Foley catheters, the most commonly used indwelling devices, are known to have 5% risk of UTI per day and virtually 100% in 30 days.

2. Improved quality of life
In published clinical studies, the In-Flow improved quality of life by 50-80%, due to the following: a) it eliminates the need to self-catheterize multiple times daily; b) it eliminates tubes and bags, improving body image (as well as hygiene); c) it allows most patients to void without assistance, increasing self-reliance; and d) it allows most patients to use a toilet again, a psychologically significant benefit since that is the “normal” way to void.
The In-Flow’s safety and effectiveness have been documented by five peer-reviewed clinical studies (total n=495) and some 1,000 women years of use! No serious or long-lasting adverse events been reported for any patient at any time. The most common complaint is device awareness/discomfort. 

Click here for a complete summary of Clinical Evidence

The In-Flow device conforms to Council Directive 93/42/EEC and bears the CE mark. U.S. Patent Nos. 5,762,599 and 6,417,750; counterparts worldwide. Additional patents issued and pending. In-Flow is a trademark of Personal Medical Corp., a business unit of SRS Medical.

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In-FlowTM Studies

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