A Clinical Trial to Evaluate the Efficacy, Safety of Fesoterodine Fumarate Extended Release Tablets 4 mg / 8 mg Versus Solifenacin Succinate Tablets 5 mg/10 mg in Adult Patients Diagnosed with Overactive Bladder with Symptoms of Urge Urinary Incontinence, Urgency, and Frequency

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2021
INTERVENTION: Intervention1: Fesoterodine Fumarate Extended Release Tablets: Fesoterodine Fumarate Extended Release 4mg/8mg Tablets. Dose: once daily with or after food, for at least 4 weeks and Maximum 12 week. Route of administration: Oral Control Intervention1: Solifenacin Succinate Tablets: Solifenacin Succinate 5 mg/10 mg Tablets. Dose:Once daily with or after food, for at least 4 weeks and Maximum 12 week. Route of Administration: Oral CONDITION: Health Condition 1: N329‐ Bladder disorder, unspecified PRIMARY OUTCOME: Number of Micturitions Per 24 HoursTimepoint: week 4, week 8 and week 12 SECONDARY OUTCOME: Number of Number of Nighttime Micturitions Per 24 HoursTimepoint: week 4 and week 8 and ; week 12 Number of Urgency Episodes per 24 HoursTimepoint: week 4 and week 8 and week 12 Number of UUI Episodes Per 24 HoursTimepoint: week 4 and week 8 and week 12 Safety AssessmentsTimepoint: week 4, week 8 and week 12 INCLUSION CRITERIA: 1. Male or female subjects aged 18 to 65 years (both inclusive) with a confirmed diagnosis of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency (including micturitions greater than equals to 8 per day and urinary urgency episodes greater than equals to 1 per day) 2. Subjects willing to give voluntarily their written informed consent to participate in the study before being screened for the study. 3. Able to adhere to the study visit schedule and other protocol requirements. 4. All women of childbearing potential must use adequate contraception throughout the study and four weeks after completion of the study or be celibate or their partner must have had a vasectomy. The screening urine pregnancy tests should be negative (if the urine pregnancy test is positive, a serum pregnancy test should be performed, and the result should be negative). Women who have been sur
Epistemonikos ID: f173777f1679dc704f81b107f495e0516c76cd00
First added on: Dec 20, 2022