Overactive Bladder
Conditions
Keywords
urinary incontinence, overactive bladder, urinary frequency
Brief summary
This study will help determine if behavior modification performed in conjunction with oral Vesicare anticholinergic therapy is more effective for treating overactive bladder symptoms than oral Vesicare anticholinergic therapy alone.
Detailed description
Overactive bladder symptoms are commonly treated with oral anticholinergic medications that work by stopping muscles from tightening or behavioral modification. This study will help determine if behavior modification (fluid regulation, pelvic exercises, timed voiding) performed in conjunction wth oral Vesicare anticholinergic therapy, is more effective for treating overactive bladder symptoms than oral Vesicare anticholinergic therapy alone.
Interventions
DRUGVesicare (solifenacin)
5mg po qd
BEHAVIORALVesicare (solifenacin) plus behavioral modification
5 mg dose po once daily plus behavioral modification
Sponsors
Astellas Pharma US, Inc.
Lahey Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Female patients \> 18 years of age * OAB symptoms for \> 3 months * Symptoms defined as greater than 3 episodes/week of an uncontrolled urge to void causing incontinence. * May or may not be accompanied by urinary frequency * May be accompanied by stress urinary incontinence where stress incontinence does not predominate
Exclusion criteria
* Male Patients * Underlying cortical or spinal cord pathology including SCI, MS, or * Parkinson's Disease * Urinary retention with post-void residual \> 150cc * Current treatment or treatment within the last 3 months with anticholinergic medications * Patients not able to complete the questionaires or voiding diaries in English * Pregnancy * Active urinary tract infections * Bladder Cancer or unevaluated hematuria * Known diagnosis of narrow angle glaucoma * Severe constipation * History of reduced renal function (CrCl\<30ml/min) * History of liver disease * Current treatment with cytochrome P450 inhibitor medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in the Number of Incontinence Episodes Per 24 Hours Measured by Voiding Diaries. | 0 week - 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of Symptom Severity | 3 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vesicare Alone Vesicare alone in treatment of incontinence | 6 |
| Vesicare Plus Behavioral Modification Vesicare plus behavioral modification for treatment of incontinence | 6 |
| Total | 12 |
Baseline characteristics
| Characteristic | Vesicare Alone | Vesicare Plus Behavioral Modification | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 4 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 2 Participants | 4 Participants |
| Region of Enrollment United States | 6 participants | 6 participants | 12 participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
Change From Baseline in the Number of Incontinence Episodes Per 24 Hours Measured by Voiding Diaries.
Time frame: 0 week - 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vesicare Alone | Change From Baseline in the Number of Incontinence Episodes Per 24 Hours Measured by Voiding Diaries. | 1 incontinence episodes per 24 hours |
| Vesicare Plus Behavioral Modification | Change From Baseline in the Number of Incontinence Episodes Per 24 Hours Measured by Voiding Diaries. | 10 incontinence episodes per 24 hours |
Secondary
Improvement of Symptom Severity
Time frame: 3 months
Population: data were not collected