Abbreviations & Acronyms ADT = androgen deprivation therapy ED = erectile dysfunction FAS = full analysis set IPSS = International Prostate Symptom Score LDR = low-dose-rate brachytherapy LUTS = lower urinary tract symptoms N.S. = not significant OABSS = overactive bladder symptom score PDE5 = phosphodiesterase-5 PSA = prostate-specific antigen PVR = postvoid residual urine volume Q max = maximum urinary flow rate QoL = quality of life SAS = safety analysis set SHIM = Sexual Health Inventory for Men UrD30% = minimal dose received by 30% of the urethral volume a1ARA = alpha 1-adrenergic receptor antagonist

Background Ao-dake-humi is a traditional Japanese bamboo foot stimulator consisting of a half-pipe-shaped step made of bamboo used to stimulate the foot by stepping on it, and is commonly used to promote general health among the elderly in Japan. However, its efficacy has not been reported in the scientific literature. This study was performed to investigate the role of ao-dake-humi focusing on lower urinary tract symptoms (LUTS), constipation, and hypersensitivity to cold (HC).MethodsParticipants with LUTS, constipation, or HC were enrolled in this study. Ao-dake-humi was used twice a day for 28 days. Before and 28 days after starting ao-dake-humi use, international prostate symptom score (IPSS), quality-of-life (QoL) score, and overactive bladder symptom score (OABSS) were measured to evaluate the efficacy of ao-dake-humi on LUTS. To evaluate the objective efficacy of ao-dake-humi on LUTS, a frequency-volume chart (FVC) was plotted in LUTS patients for 3 days. A visual analogue scale (VAS) was used to evaluate the efficacy of ao-dake-humi on constipation (VAS-constipation) and HC (VAS-HC) in the participants with constipation or HC.ResultsA total of 24 participants were enrolled in this study. Twenty-one participants had LUTS, 11 had constipation, and 17 participants had HC. IPSS, especially storage-subscore, QoL score and OABSS, decreased significantly after use of ao-dake-humi. The use of ao-dake-humi increased maximal bladder capacity, resulting in a significant decrease in urinary frequency as determined from the FVC. In accordance with the results of VAS-constipation and VAS-HC, both constipation and HC were significantly relieved after ao-dake-humi use.ConclusionThe results of this prospective pilot study indicated that ao-dake-humi is safe and has therapeutic efficacy in cases of LUTS, constipation and HC. The possibility of using ao-dake-humi as physical neuromodulation therapy was shown in the management of LUTS, constipation and HC.Trial registration UMIN000019333 (UMIN-CTR, Registered October-15-2015) retrospectively registered.