A Phase 3 interventional study of Vesicare (solifenacin) and Vesicare (solifenacin) plus behavioral modification in Overactive Bladder, sponsored by Lahey Clinic. Terminated at 1 site in United States. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-04-04.
Sponsored by Lahey Clinic · Phase 3, Interventional, and Treatment
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.
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.
864 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.
This study's enrollment of 12 is below the median of 70 across 660 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →Lahey Clinic is the lead sponsor of 61 studies on the registry; 4 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Vesicare alone
Drug: Vesicare (solifenacin)
Vesicare plus behavioral modification
Behavioral: Vesicare (solifenacin) plus behavioral modification
5mg po qd
5 mg dose po once daily plus behavioral modification
Also known as: Vesicare (solifenacin)
Change From Baseline in the Number of Incontinence Episodes Per 24 Hours Measured by Voiding Diaries.
Time frame: 0 week - 12 weeks
Improvement of Symptom Severity
Time frame: 3 months
| Milestone | Vesicare Alone | Vesicare Plus Behavioral Modification |
|---|---|---|
| Started | 6 | 6 |
| Completed | 6 | 6 |
| Not completed | 0 | 0 |
| incontinence episodes per 24 hours | Vesicare Alone | Vesicare Plus Behavioral Modification |
|---|---|---|
| Change From Baseline in the Number of Incontinence Episodes Per 24 Hours Measured by Voiding Diaries. | 1 (0 to 5) | 10 (2 to 22) |
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vesicare Alone | — | 0/6 (0%) | 0/6 (0%) |
| Vesicare Plus Behavioral Modification | — | 0/6 (0%) | 0/6 (0%) |
| Age, Categorical(Participants) | Vesicare Alone | Vesicare Plus Behavioral Modification | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 2 | 4 |
| >=65 years | 4 | 4 | 8 |
| Sex: Female, Male(Participants) | Vesicare Alone | Vesicare Plus Behavioral Modification | Total |
|---|---|---|---|
| Female | 6 | 6 | 12 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Vesicare Alone | Vesicare Plus Behavioral Modification | Total |
|---|---|---|---|
| United States | 6 | 6 | 12 |
The record gives a start of Sep 2006, a primary completion of Sep 2008 and a completion of Sep 2008. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2010, 1 year 10 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Solifenacin
Lahey Clinic