Urinary Bladder, Overactive
Conditions
Brief summary
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.
Interventions
DRUGtolterodine extended release
Tolterodine ER capsule 4 mg daily for 12 weeks
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to Week 12 in the micturition bladder diary variable related to the primary symptom of the patient at the time of study entry | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to Week 4 and 12 in micturition bladder diary variables | 12 weeks |
| Change from baseline to Week 4 and 12 in Patient's Perception of Bladder Condition | 12 weeks |
| Change from baseline to Week 4 and 12 in AUA Symptom Index | 12 weeks |
| OAB Bother Rating Scale at baseline | baseline |
| Clinical Global Impression-Improvement at Week 12 | 12 weeks |
| Overall Treatment Effect Scale of Overactive Bladder Control at Week 4 and 12 | 12 weeks |
| To asses the safety of tolterodine in patients with OAB | 12 weeks |
| Change from baseline to Week 4 and 12 in OAB questionnaire | 12 weeks |
Countries
United States
Outcome results
None listed