A Study to Evaluate the Efficacy of Tolterodine on Specific Symptoms in Adult Patients With Overactive Bladder.

Viatris

Status and phase

Completed

Phase 4

Conditions

Urinary Bladder, Overactive

Treatments

Drug: tolterodine extended release

Study type

Interventional

Funder types

Industry

Identifiers

A6121001

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of tolterodine in impacting the primary symptom or complaint of patients with OAB.

Enrollment

896 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

self-reported symptoms of OAB for ≥ 3 months prior to screening
OAB as defined by urinary frequency (a minimum of 8 micturitions per 24 hours)
urgency (defined as a strong and sudden desire to urinate) or urge incontinence a minimum of 2 episodes in 3 days, as confirmed by the micturition diary between screening and baseline
patients who describe the degree of bothersomeness of their most bothersome OAB symptom as "moderately ", "a great deal ", or "a very great deal" per the OAB Bother Rating Scale

Exclusion criteria

any condition that would contraindicate their usage of tolterodine once daily, including: narrow angle glaucoma, urinary retention, gastric retention
any clinically significant local urinary tract pathology which could mimic the symptoms of OAB, such as infection or hematuria
stress incontinence, functional, or overflow incontinence as determined by the investigator
symptomatic acute urinary tract infection (UTI) during the run-in period, or recurrent UTIs defined by treatment for symptomatic UTI >3 times in the 12 months prior to participation in this clinical trial
clinically significant urinary tract obstruction
history of lower urinary tract surgery (e.g. prostate removal or destruction, incontinence surgery) within the past 3 months
clinically significant interstitial cystitis or significant bladder pain syndrome