The Urethro-Cystometer™ is a noninvasive instrument and method for determining the cause of lower urinary tract symptoms (LUTS).
Symptoms such as frequency of urination, intermittent urine flow, nocturia and "weak stream" can be significant life-style challenges for the elderly male. When the "bother" of LUTS becomes too severe the patient will seek medical care. The usual medical management for the LUTS patient is a course of "therapeutic-diagnostic" testing, first with a trial of oral medications, and if these don't work, a trial of prostate surgery. The surgery is effective in about 3 out of 4 cases. However, about 1 in 4 patients does not benefit from the surgery because the LUTS is due to bladder dysfunction rather than an enlarged prostate. Also, about 5% of surgical patients develop significant surgical side-effects. There needs to be a less risky method for differential diagnosis of LUTS.
Currently, there is an alternative non-surgical method to diagnose bladder dysfunction as the cause for LUTS, invasive urodynamics. However, urodynamic testing is costly, uncomfortable, and like surgery, can have significant side-effects. Since urodynamics involves placement of catheters in the bladder it is associated with a significant rate of infection and other complications. Therefore, urodynamic testing is generally not performed until after surgery fails to relieve the LUTS.
The BioFluid Noninvasive Urethro-Cystometer™ (NUC™) can distinguish the two main causes of LUTS in males: bladder weakness due to poor detrusor contraction versus urethral obstruction due to an enlarged prostate encroaching on the urethra (BPH). The device can also facilitate analysis of bladder muscle dysfunction in females. LUTS affects a large portion of the elderly throughout the world. In the U.S. alone, the cost of surgical treatment for LUTS exceeds $3 billion annually (much from Medicare), with about $1 billion wasted on unneeded prostate surgery and its side effects including pain, trauma, bleeding, infection, incontinence, and impotence. These costs result from the lack of a safe and convenient noninvasive diagnostic method to distinguish bladder weakness from urethral obstruction. Also, these invasive tests cannot be conveniently repeated to confirm diagnostic findings or evaluate response to treatment.
In contrast to "therapeutic-diagnostic" surgery and invasive urodynamics, the BioFluid Urethro-Cystometer™ test is completely noninvasive, simple, painless and inexpensive to perform. Yet it is automated enough to permit in-office testing without the need for highly trained personnel. This test takes only the time needed to urinate into the device, and the test may be conveniently repeated to evaluate response to treatment.
The BioFluid Urethro-Cystometer™ can contribute to more cost-effective treatment of LUTS. The BioFluid Urethro-Cystometer™ has been licensed to a medical device manufacturer and is currently undergoing marketing and distribution.
Representative NUC Flow-Pressure Curves showing the difference between an obstructed male (Low Flow, High Pressure) compared to a normal male (High Flow, Low Pressure).