Evaluation of a Prostate Stimulation Device For Men

Lower urinary tract symptoms (LUTS) which include voiding and pelvic symptoms are common in men with benign prostatic hyperplasia (BPH) and chronic prostatitits chronic pelvic pain (CP/CPPS). The use of prostate stimulation for the detection of bacteria and further analysis of seminal and post-massage voided urine has been previously described. Utility of in-office prostate massage has also been documented as a procedure that may alleviate LUTS symptoms. Given the need to alleviate LUTS symptoms in men with BPH or CP/CPPS, who we retrospectively evaluated data on men elected to use an athome-use prostate stimulation device to reduce their symptoms in order to determine if there was evidence to warrant a
clinical trial that may help to determine safety, efficacy, dosage and frequency of use.

Our results demonstrate that a number of men were using the device. The average age of BPH subjects and CP/CPPS subjects was consistent with known disease characteristics.

In general, we found that the majority of subjects were using the device for a short period of time (<4 weeks) prior to completing the follow-up questionnaire but there were significant reductions in the total CPSI scores in both Groups. Interestingly, the pain and urinary sub scores of CP/CPPS subjects were not statistically different at baseline versus follow-up, but all domain scores of the BPH subjects were statistically significant. Moreover, about half of the subjects reported very good improvement. Two reported
concerns of men were that the device was difficult to use and the men were unsure of proper application, frequency, and duration of use. This device may have various advantages over traditional in-office prostate massage including the potential for increased frequency, which may in turn alleviate symptoms more rapidly, and less stigma or mental burden on the patient when using it in the privacy of the home.

In addition, spanning a decade with over 250,000 devices in use, no serious adverse events have been reported, providing preliminary evidence about the safety of its use. However, further studies of merit should include clinical research involving evaluation of safety, testing of optimal duration, and frequency of use. There are several limitations to the present evaluation. First, it is a retrospective review and there is no direct comparison between the device and traditional in-office prostate massage. While we attempted to minimize the bias of a retrospective study by collecting objective data and utilizing a validated questionnaire, it can be argued that utilization of the CPSI as a measurement tool in men with BPH is not valid. However, the reason we utilized the CPSI as a measurement tool for men with LUTS symptoms related to BPH or CP/CPPS was because we wanted to capture reported pain in the BPH Group that is not commonly captured by quantitative questionnaires usually used in BPH patients such as the AUA and IPSS symptom scores, both of which primarily focus on voiding symptoms. Another limitation is that more data on characteristics of use were not measured; for example, the duration of device use was recorded but the frequency of use (i.e., number of times used per week) was not standardized. Additionally, while it was
reported that many of these men were refractory to conventional pharmacologic measures, the dosage and type of medications (i.e., alpha-blockers, non-steroidal antiinflammatory agents, antibiotics, etc.) were not recorded.

Finally, the demographics of this population are relatively homogenous, and more data needs to be collected on race and anthropomorphic characteristics as the device is available in three sizes based on the height of the user. In conclusion, traditional in-office prostate massage has demonstrated potential benefit in alleviating LUTS symptoms in men with BPH and CP/CPPS. These significant results demonstrate that the application of an at-home-use prostate massage device may relieve LUTS in men with BPH and CP/CPPS. However, dosage with regard to frequency and duration need to be determined and monitoring of safety must be considered. Based on these findings we conclude that the at-home-use prostate massage
device warrants further analysis in a controlled prospective clinical trial.

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