PURPOSE: We developed a prototype device using an automatically controlled inflatable penile cuff to measure bladder voiding pressure continuously and non-invasively in men. The purpose of this study was to validate the pressure measurements made by this device by comparison to those during simultaneous invasive PFS. METHODS: A device was developed to automatically modulate flow rate by controlling pressure in a penile cuff. Men undergoing conventional urodynamics studies were recruited to have an additional fill-void cycle whilst using the new device. We report on 40 men using a standardized protocol. Pressure measured by this device was compared with simultaneous vesical pressure by evaluating maximum pressure during voiding, and calculating the root mean square (RMS) difference between p(cuff) and p(ves) . RESULTS: We recruited 80 men of whom 18 were excluded, 22 were involved in initial development phase and 40 in the standard protocol. Mean (SD) difference between maxima of p(cuff) and p(ves) (1.3 (15.6) cmH(2) O) was not significant. In 20 (50%) men, agreement between p(cuff) and p(ves) throughout the void was moderate or good (RMS difference <20 cmH(2) O). Causes of unsuccessful measurements were identified. CONCLUSIONS: Although a prototype device, this technique appears to be promising for continuous non-invasive bladder pressure measurement. From the results of this study a number of improvements have been recommended and implemented. The next generation of this technique will allow assessment of clinical application.
PURPOSE: We developed a prototype device using an automatically controlled inflatable penile cuff to measure bladder voiding pressure continuously and non-invasively in men. The purpose of this study was to validate the pressure measurements made by this device by comparison to those during simultaneous invasive PFS. METHODS: A device was developed to automatically modulate flow rate by controlling pressure in a penile cuff. Men undergoing conventional urodynamics studies were recruited to have an additional fill-void cycle whilst using the new device. We report on 40 men using a standardized protocol. Pressure measured by this device was compared with simultaneous vesical pressure by evaluating maximum pressure during voiding, and calculating the root mean square (RMS) difference between p(cuff) and p(ves) . RESULTS: We recruited 80 men of whom 18 were excluded, 22 were involved in initial development phase and 40 in the standard protocol. Mean (SD) difference between maxima of p(cuff) and p(ves) (1.3 (15.6) cmH(2) O) was not significant. In 20 (50%) men, agreement between p(cuff) and p(ves) throughout the void was moderate or good (RMS difference <20 cmH(2) O). Causes of unsuccessful measurements were identified. CONCLUSIONS: Although a prototype device, this technique appears to be promising for continuous non-invasive bladder pressure measurement. From the results of this study a number of improvements have been recommended and implemented. The next generation of this technique will allow assessment of clinical application.