Detrol LA In Men With Overactive Bladder.

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.600 enrolled

Overview

An interventional active/placebo double blinded parallel randomized controlled study in which at 12 weeks of treatment, the primary endpoint of patient perception of bladder condition is measured along with associated safety and other secondary endpoints like bladder diary endpoints, quality of life and patient treatment satisfaction. Patients included in the study must have symptoms of OAB (frequency of at least 8 per day and Urgency of at least 1 episode per day confirmed by bladder diary). Patients are not eligible to enroll in the study if they have/had significant hepatic or renal disease, history of radiation treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

600

Conditions

Overactive Bladder (OAB)

Interventions

Eligibility

Sex: MALEMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Symptoms of OAB (frequency more than 8 per day and Urgency more than 1 episode per day confirmed by bladder diary) Exclusion Criteria: * Significant hepatic or renal disease, history of radiation treatment

Locations (81)

Pfizer Investigational Site

Anaheim, California, United States

Pfizer Investigational Site

La Mesa, California, United States

Pfizer Investigational Site

Aurora, Colorado, United States

Pfizer Investigational Site

Iowa City, Iowa, United States

Pfizer Investigational Site

Shreveport, Louisiana, United States

Outcomes

Primary Outcomes

Patient Perception of Bladder Condition at 12 weeks of treatment

Secondary Outcomes

1)To evaluate the additional benefit of 'Add-On' tolterodine L-tartrate ER (Detrol LA?), vs. placebo, to alpha-blocker therapy in men with persistent OAB symptoms of urinary frequency and urgency with/without urgency incontinence: a)On OAB symptoms as

assessed by 5-day voiding bladder diaries including Urinary Sensation Scale, b)On symptoms as assessed by the International Prostate Symptom Score (IPSS), c)On patient perception of treatment benefit as assessed by the Patient Perception of Treatment

Benefit Questionnaire (PPTB) , d)On patient perception of bladder condition as assessed by the change in the PPBC after 4 weeks of treatment, e)On bothersome quality of life (QoL) symptoms as assessed by the Overactive Bladder Questionnaire (OAB-q),

f)On sexual QoL as assessed by the ICIQ-MLUTSsex Questionnaire , g)On patient satisfaction with medication as assessed by the Overactive Bladder Treatment Satisfaction Questionnaires (OAB-s), h)On nocturia bothersome measure as assessed by the Nocturia

Quality-of-Life Questionnaire, 2)To evaluate the safety and tolerability of 'Add-On' tolterodine L-tartrate ER (Detrol LA?), vs. placebo, to alpha-blocker therapy in men with persistent OAB symptoms of urinary frequency and urgency with/without urgency

incontinence.