Overactive Bladder, Urinary Incontinence
Conditions
Brief summary
This study is designed to investigate whether a new drug may offer safe and effective treatment for patients with overactive bladder.
Interventions
DRUGMK0594
Sponsors
Vyne Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* Patients with predominantly urge incontinence overactive bladder episodes * Patients must meet minimum eligibility requirements (e.g., average number of micturitions/day) based on screening diary cards
Exclusion criteria
* History of Diabetes insipidus, uncontrolled hyperglycemia or hypercalcemia * Lower urinary tract symptoms associated with benign prostatic hypertrophy * Active or current Urinary Tract Infections (UTIs) * Surgery to correct prolapsed uterus or stress incontinence
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in baseline in average daily micturitions as recorded on patient voiding diaries. | Duration of Trial | Change in baseline in average daily micturitions as recorded on patient voiding diaries. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of dry mouth. | Duration of Treatment | The incidence of dry mouth. |
| Average daily strong urgency, total incontinence, and Urge UI episodes from voiding diaries. | Duration of Treatment | Average daily strong urgency, total incontinence, and Urge UI episodes from voiding diaries. |
| Global assessment of improvement in UI, perception of urgency, and bother of UI symptoms. | Duration of Treatment | Global assessment of improvement in UI, perception of urgency, and bother of UI |
Outcome results
None listed