Underactive bladder
Conditions
Interventions
Subjects are randomly assigned to the ZG-802 dose A group, ZG-802 dose B group, or placebo group, and orally administered three times a day before each meal for 12 weeks. The visit for this study was
Sponsors
Tomioka Yusuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who have any symptoms of slow stream, hesitancy or straining to void for more than 90 days before the Screening date 2) Patients who meet all the specified criteria of uroflowmetry and transabdominal ultrasonographya for both Screening and Baseline 3) Patients with a score of specified points or more in any item of voiding symptoms (intermittency, slow stream and straining to void) of the International Prostate Symptom Score for Baseline 4) Patients aged 18 years or older at the time of informed consent
Exclusion criteria
Exclusion criteria: 1) Patients with a urgency score of 2 or more on the Overactive Bladder Symptom Questionnaire during the observation period 2) Patients with bladder outlet obstruction who meet one or more of the following a) Female patients with pelvic organ prolapse of stage III or higher in the POP - Q stage classification b) Male patients with Intravesical prostatic protrusion >= 10 mm c) Male patient with prostate cancer d) Patients with severe urethral stricture requiring surgery e) Patients who do not fall under a) to d) but are judged by investigators to have a clinically problematic bladder outlet obstruction 3) Patients with urethral diverticulum or extremely large bladder diverticulum 4) Patients with ureteral calculus, vesical calculus or urethral calculus 5) Patients with progressive neurodegenerative disease (e.g. Parkinson's disease, multiple system atrophy, progressive supranuclear palsy) 6) Patients with neurological diseases other than progressive neurodegenerative diseases who show a clear exacerbation or recovery tendency (e.g., cerebrovascular disease, normal pressure hydrocephalus, cerebral white matter lesion, spinal cord injury, multiple sclerosis) , vascular disease of spinal cord, lumbar diseases (spinal canal stenosis, degenerative spondylolisthesis, lumber vertebrae herniated disk, etc.), diabetic neuropathy) 7) Patients with increased pelvic floor muscle activity during urination (e.g., striated sphincter incoordination, Fowler's syndrome, pelvic floor muscle spasms) 8) Patients with or suspected of having a symptomatic urinary tract infection or genital infection 9) Patients with severe urinary organ pain 10) Patients who have recieved certain treatments, patients who have been treated within certain period, or patients who are expected to be treated them during the treatment period 11) Patients who have changed the dosage and administration of certain drugs within certain period, or patients who are expected to change during the treatment period 12) Patients who are encouraged to urinate by applying pressure from outside the body such as the Crede's procedure, valsalva maneuver or by tapping 13) Patients with a history of surgery for the lower urinary tract, prostate, or pelvic organ prolapse, or expected to be performed during the treatment period (However, patients may be included if the surgery was performed more than 180 days prior to the screening date and the investigator judges that the patient was free of urethral stricture or urethral obstruction as of the baseline date) 14) Patients judged by the investigator to be unable to properly record the bladder diary of Baseline 15) Patients who have used other investigational drugs within the past 30 days including the screening date, or patients whose period between the time of use of other investigational drugs and the screening date is within 5 times the half-life of the relevant investigational drug 16) Patients with clinically significant heart disease, liver disease, renal disease, blood disease, etc. 17) Patients with allergy to certain chemical substances 18) Patients with malignant tumors. Patients who have been treated for malignant tumors or have had a malignant tumor, in the past 5 years including the baseline date. 19) Female patients who are pregnant or breastfeeding. Male patients and premenopausal female patients who are unable to use adequate contraception during the study period and for 7 days after the end of study d
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in post-void residual from baseline to week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Post-void residual, Change in Bladder voiding efficiency | — |
Contacts
Public ContactYusuke Tomioka
Zeria Pharmaceutical Co., Ltd.
Outcome results
None listed