Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Astellas Pharma Korea, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to compare the effect of solifenacin succinate between frequent micturition patients with urgency and those without urgency.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| with urgency | Experimental |
| |
| without urgency | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solifenacin | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| change of micturition frequency on a 3-day voiding diary | after 12-week treatment |
| Measure | Description | Time Frame |
|---|---|---|
| change in patient's perception of bladder condition | after 12-week treatment | |
| change in OAB symptom scores | after 12-week treatment | |
| patient's satisfaction with the treatment |
Not provided
Inclusion Criteria:
For the without-urgency group:
For the with-urgency group:
Symptoms lasting for more than 3 months
Exclusion Criteria:
Clinically significant stress incontinence as determined by the investigator; for female patients, clinically significant stress incontinence confirmed by a cough provocation test
Total daily urine volume of > 3000 mL as verified on the micturition diary before randomization
Significant hepatic or renal disease, defined as having twice the upper limit of the reference ranges for serum concentrations of aspartate aminotra
Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention
Symptomatic acute urinary tract infection (UTI) during the run-in period
Recurrent UTIs defined as having been treated for symptomatic UTIs > 4 times in the last year
Diagnosed or suspected of interstitial cystitis
Uninvestigated hematuria or hematuria secondary to a malignant disease
Clinically significant bladder outlet obstruction defined by clinical symptoms and investigator's opinion according to local standard of care (residual urine> 100mL of functional bladder capacity)
Patients with marked cystocele or other clinically significant pelvic prolapse
Treatment within 14 days preceding randomization, or expected to initiate treatment during the study with:
On an unstable dosage of any drug with anticholinergic side effects, or expected to start such treatment during the study
Receipt of any electrostimulation or bladder training within 14 days before randomization, or expected to start such treatment during the study
An indwelling catheter or practicing intermittent self-catheterization
Use of any investigational drug within 1 month prior to the start of the study
Patients with chronic constipation or history of severe constipation
Pregnant or nursing women
Sexually active females of childbearing potential not using reliable contraception for at least 1 month prior to the start of the study and not agreeing to use such methods during the entire study period and for at least 1 month thereafter. Reliable contraceptive methods are defined as intrauterine devices (IUDs), combination type contraceptive pills, hormonal implants, double barrier method, injectable contraceptives and surgical procedures (tubal ligation or vasectomy)
Patients who have bladder cancer or prostate cancer
Treatment with potent CYP3A4 inhibitors, such as cyclosporine, vinblastine, macrolide antibiotics (e.g. erythromycin, clarithromycin, azithromycin) or antifungal agents (e.g. ketoconazole, itraconazole, micronazole)
Patients who have neurological disease
Patients who have psychological disease
Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Myung-Soo Choo, Professor | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daegu | 700-712 | South Korea | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25401784 | Derived | Han JY, Lee KS, Park WH, Park CH, Lee JG, Lee JZ, Kim DY, Na YG, Kwon DD, Choo MS. A comparative study on the efficacy of solifenacin succinate in patients with urinary frequency with or without urgency. PLoS One. 2014 Nov 17;9(11):e112063. doi: 10.1371/journal.pone.0112063. eCollection 2014. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| after 12-week treatment |
| Daegu |
| 705-718 |
| South Korea |
| Daejeon | 301-721 | South Korea |
| Inchon | 400-711 | South Korea |
| Jeonnam | 519-809 | South Korea |
| Pusan | 602-739 | South Korea |
| Seoul | 135-170 | South Korea |
| Seoul | 135-705 | South Korea |
| Seoul | 138-736 | South Korea |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069464 | Solifenacin Succinate |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided