A Double-Blind, Randomized, Parallel Group, Multi-Centre Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Subjects with Overactive Bladder (OAB) Treated with Antimuscarinics and Dissatisfied due to Lack of Efficacy

Phase 3

Completed

• Conditions: frequent miction; Overactive bladder; urgency and urgency-incontinence; 10004994

• Registration Number: NL-OMON37799
• Lead Sponsor: Astellas Pharma B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

1.Subject has symptoms of OAB (urinary frequency and urgency with or without urgency incontinence) for >= 3 months prior to the Screening Visit.
2.Subject is currently or has previously received at least one antimuscarinic agent intended to treat their OAB.
3.The perception of the last treatment satisfaction on a 7 item Likert scale is extremely, very, or slightly dissatisfied.
4.Subject is willing and able to complete a micturition diary and questionnaires.
See protocol page 38 and 39 for all inclusion criteria.

Exclusion Criteria

1.Subject has clinically significant Bladder Outlet Obstruction (BOO).
2.Subject has neurogenic bladder.
3.Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor.
4.Subject has an indwelling catheter or practices intermittent self-catheterization.
5.Subject has diabetic neuropathy.
6.Subject has evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs.
7.Subject has moderate to severe hepatic impairment defined as Child-Pugh Class B or C.
8.Subject has severe renal impairment or End Stage Renal disease defined as eGFR < 29 ml/min/1.73 m2.
9.Subject has severe uncontrolled hypertension defined as a sitting average systolic blood pressure >= 180 mmHg and/or average diastolic blood pressure >= 110 mmHg.
10.Subject*s last anti-muscarinic treatment was solifenacin.
See protocol page 39-41 for all exclusion criteria.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Change from baseline in the mean number of micturitions per 24 hours, based<br /><br>on a 3-day micturition diary</p><br>