Overactive Bladder (OAB)
Conditions
Interventions
Take one tablet once a day after breakfast with water.
Sponsors
Takara Tsuyoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Male or female 3. Subjects aged 50 or more 4. Subjects who wake up more than twice to urinate at bedtime 5. Subjects with symptoms of overactive bladder (urination frequency of 8 times or more per day and urinary urgency of 1 time or more per week) 6. Subjects who are judged as eligible to participate in the study by the physician 7. Subjects with a high-sensitivity PSA level of less than 4 ng/mL at the screening test 8. Subjects with an OABSS urinary urgency score of at least 2 and a total OABSS score of at least 3 at the screening test 9. Subjects whose average daytime urination frequency of 8 or more times in the 7 days prior to the screening test 10. Subjects whose average nocturnal voiding frequency of 2 or more times in the 7 days prior to the screening test 11. Subjects with a relatively high "degree of trouble" on the OAB-q at the screening test
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who are undergoing treatment, have had treatment within two months, or need the treatment for diseases related to urination, e.g. benign prostatic hypertrophy, prostatitis, prostate cancer, overactive bladder, hypoactive bladder, cystitis, interstitial cystitis, bladder cancer, bladder stones, urethritis, urethral stricture, neurological disease, polyuria, and nocturnal polyuria 5. Subjects who drink to excess (average of more than about 20 g/day as absolute alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)} 6. Subjects who use or take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily 7. Subjects who are currently taking medications (including herbal medicines) and supplements 8. Subjects who are allergic to medicines and/or the test food related products 9. Subjects who are pregnant, breast-feeding, and planning to become pregnant 10. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 11. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The measured values "symptom bother" of Overactive Bladder questionnaire (OAB-q) at 8 weeks after consumption (8w). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The amount of change of "symptom bother" of OAB-q between screening (before consumption: Scr) and 8w 2. The measured values and amount of change from Scr "symptom bother" of OAB-q at 1w, 4w, and 12w 3. The measured values and amount of change from Scr of "coping", "concern", "sleep", "social interaction" and "the effect of QOL" of OAB-q at 1w, 2w, 4w, and 8w 4. The measured values and amount of change from Scr of "daytime frequency", "nighttime frequency", "urgency", "urgency incontinence" and "total score" of Overactive Bladder Symptom Score at 4w, and 8w 5-1*. The average frequency of urination in the daytime, in the nighttime, and all day in each period III to period XIV 5-2*. The amount change from period I of average frequency of urination in the daytime, in the nighttime, and all day in each period III to period XIV 5-3*. The amount change from period II of average frequency of urination in the daytime, in the nighttime, and all day in each period III to period XIV *Period I: 7 days prior to Scr Period II: 7 days from 1 week prior to the start of intake to the day before the start of consumption Period III: 1st week of the start of consumption Period IV: 2nd week of the start of consumption Period V: 3rd week of the start of consumption Period VI: 4th week of the start of consumption Period VII: 5th week of the start of consumption Period VIII: 6th week of the start of consumption Period IX: 7th week of the start of consumption Period X: 8th week of the start of consumption Period XI: 9th week of the start of consumption Period XII: 10 weeks of the start of consumption Period XIII: 11th week of the start of consumption Period XIV: 12th week of the start of consumption | — |
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc.
Outcome results
None listed