Nocturia more than twice a night
Conditions
Interventions
Goshajinkigan (Tsumura Co., Ltd.). 2.5g twice a day, before breakfast and dinner (can be taken after meals if stomach discomfort occurs). The period of administration is 12 weeks or more if possible
Sponsors
Urological Kampo Research Society
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Elderly patients aged 65 or older with nocturia (including benign prostatic hyperplasia [BPH] and overactive bladder [OAB]) who awaken twice or more during the night. The severity of BPH/OAB is not important (including mild cases with an IPSS score of 0-7). 2) Patients with dissatisfaction with an IPSS-QOL score of 3 or higher (mixed about equally satisfied and dissatisfied regarding the continuation of their current urinary condition). 3) Patients with Jin-kyo (fatigue and lethargy are easily recognized, weakness and chills in the lower body, decreased or frequent urination, and sometimes dry mouth) and with weakness of the lower abdominal region (Jin-kyo score of 13 or higher). 4) Regardless of the presence or absence of sleep disorders or testosterone deficiency.
Exclusion criteria
Exclusion criteria: 1) Patients who discontinued, started, or changed the dosage of urinary dysfunction medication within the past month. 2) Patients who discontinued or started antiandrogens (including 5alpha reductase inhibitors) within the past six months (men). 3) Patients who changed the dosage of medications that may affect urination during the study period (antihypertensives, hypnotics, erectile dysfunction medications [for men], diuretics, antidiuretic hormone preparations, etc.). 4) Patients who spent long periods of time in bed during the day (patients who were generally active during their daily lives were generally included). 5) Patients with untreated organic diseases of the lower urinary tract (benign prostatic hyperplasia, prostate cancer, bladder neck contracture, urethral stricture, bladder tumors, bladder stones, etc.) or active urinary tract infections (bacterial cystitis, bacterial prostatitis, etc.).(This is an option for patients with treatment-resistant chronic urinary tract infections without subjective symptoms or obvious signs of infection, but it is preferable to avoid it if possible.) 6) Patients with clinically significant signs of heart failure (symptoms due to exercise, apparent increased CTR, NT-proBNP >= 300 pg/ml). 7) Patients with no desire to urinate or postvoid residual urine volume of 100 ml or more. 8) Other cases in which the attending physician judges enrollment in this study to be inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of nocturnal urinary frequency (average of voiding diary for 3 days) before and after 12 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Comparison of PSQI (Pittsburgh Sleep Quality Index), IPSS (International Prostate Symptom Score), IPSS-QOL, and OABSS (Overactive Bladder Symptom Score) before and after 12 weeks of treatment, 2) Comparison of modified nocturnal polyuria index (mNPI, which is corrected assuming NPI is 8 hours) before and after 12 weeks of treatment. | — |
Countries
Japan
Contacts
Public ContactHitoshi Oh-oka
Independent administrative agency, National Hospital Organization, Kobe Medical Center Department of Urology
Outcome results
None listed