Overactive Bladder (OAB)
Conditions
Brief summary
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.
Interventions
DRUGDetrol LA
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient Perception of Bladder Condition at 12 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 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), | — |
| 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 | — |
| 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. | — |
| 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 | — |
Countries
Canada, Denmark, Germany, Italy, Mexico, Norway, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom, United States
Outcome results
None listed