Overactive Bladder
Conditions
Interventions
Subjects who are maintained on either VESIcare (5 mg once daily), Uritos (0.1 mg twice daily), or BUP-4 (20 mg once daily) will be enrolled in this evaluation. After being treated with anti-muscarini
Sponsors
Department of Urology, Nihon University Itabashi Hospital
PPCJ corporation
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Females 20-80 years 2)Subjects with a history of OAB who are currently taking one of the following products 1.VESIcare (5 mg once daily), 2.Uritos(0.1 mg twice daily), or 3.BUP-4 (20 mg once daily)for at least 8 weeks (OD formulation of these products are not allowed for at least last 4 weeks) 3)Subjects who do not display overt symptoms of OAB.At baseline the following criteria must be met: oUrinary frequency <13 micturitions per day, as recorded in the subject diary with or without symptoms of urgency (i.e., sudden desire to micturate) oHistory of urge or mixed urinary incontinence with predominant urge incontinence oMaximum of one urge incontinence episode per day over a 3-day period 4)Symptoms of OAB for 3 or more months 5)Dry Mouth Questionnaire Q1, VAS>=25 6)Able and willing to correctly and independently complete the subject urinary diaries for 3 days 7)Ability to use bathroom without assistance 8)Females of childbearing potential must have had a negative pregnancy test at the time of enrollment. They should not be breast-feeding, and not at an appreciable risk of becoming pregnant. All pre-menopausal subjects must be using a highly effective method of birth control during the study and for at least one month following the last dose of study medication. (Menopause defined as at least one year without menses.) A negative pregnancy test must be documented prior to treatment. A highly effective method of birth control is defined as one that results in a low failure rate (i.e., < 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence, or a vasectomized partner.
Exclusion criteria
Exclusion criteria: 1)stress incontinence, insensate incontinence and overflow incontinence, as major reason for urine loss or urinary frequency as determined by the investigator 2)history of neurogenic bladder 3)uninvestigated hematuria 4)acute urinary tract infections during the anti-muscarinic baseline period or recurrent UTI defined as receiving treatment for symptomatic UTI more than 2 times in the past year 5)indwelling catheter or requiring intermittent catheterization 6)bladder or lower urinary tract surgeries performed within the past 6 months, or those who had surgeries leading to complications such as fistula 7)diagnosed with bladder cancer, interstitial cystitis, or painful bladder syndrome within the past 6 months 8)taking diuretics or estrogen therapy that was not part of a long-term stable program of at least 6 months 9)severe renal impairment (CLCR<30mL/min) 10)taking potent CYP3A4 inhibitors, such as ketoconazole, itraconazole, and clarithromycin 11)severe hepatic impairment 12)employing bladder retraining/bladder drill programs 13)Subjects who were anticipated to begin or change other bladder therapies (non-medicinal) such as biofeedback or kegels, during the course of the study 14)Subjects with malignancy within the past 6 months or prior pelvic malignancies requiring radiation therapy or whose surgery had led to complications such as fistulas, etc 15)diagnosed Sjogrens syndrome 16)History of tachyarrhythmias or cardiac disease 17)Any medications that may interfere with the subject's suitability and/or effective participation in the study 18)history or current untreated narrow angle glaucoma 19)history of myasthenia gravis 20)the known or suspected biliary tract disease, nephrolithiasis, cognitive or psychiatric disturbances 21)hypersensitivity toward Solifenacin or pilocarpine or to any excipient in their respective formulations 22)participating in another clinical trial or receiving a non-approved drug less than 30 days prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare change from baseline with 2weeks and 4weeks in the average number of micturitions per 24 hours Compare change from baseline with 2weeks and 4weeks inthe average number of incontinence episodes per 24 hours Compare change from baseline with 2weeks and 4weeks in dry mouth symptomatology (visual analog scale) | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events will be used to assess tolerability of the combination. | — |
Countries
Japan
Contacts
Public ContactChikako Takeda
PPCJ corporation Clinical Research Division
Outcome results
None listed