Anti-Muscarinic Agents Alone and in Combination With a Muscarinic Agonist in Subjects with Overactive Bladder(OAB) Symptoms

Not Applicable

• Conditions: Overactive Bladder

• Registration Number: JPRN-UMIN000007108
• Lead Sponsor: Department of Urology, Nihon University Itabashi Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-31
• Study Completion: 2012-06-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 18

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified