Overactive BladderPhase 3NCT00821184
Behavioral Modification and Vesicare Versus Vesicare Alone for Urge Incontinence in Patients With Overactive Bladder
A Phase 3 study testing Vesicare (solifenacin) and Vesicare (solifenacin) plus behavioral modification in people with Overactive Bladder, run by Lahey Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Vesicare (solifenacin) and Vesicare (solifenacin) plus behavioral modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Sep 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Trial of Behavioral Modification and Solifenacin (Vesicare)vs Solifenacin (Vesicare) Alone for the Treatment of Urge Incontinence in Patients With an Overactive Bladder
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.
Read the 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.
- Conditions
- Overactive Bladder
- Being tested
- Vesicare (solifenacin), Vesicare (solifenacin) plus behavioral modification
- Keywords
- urinary incontinence, overactive bladder, urinary frequency
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vesicare (solifenacin)Drug
5mg po qd
Vesicare (solifenacin) plus behavioral modificationBehavioural
Also called Vesicare (solifenacin)
5 mg dose po once daily plus behavioral modification
| Study group | Role | What they receive |
|---|---|---|
| Vesicare | Active comparator | Vesicare alone Receives: Drug: Vesicare (solifenacin) |
| Vesicare/behavioral modification | Active comparator | Vesicare plus behavioral modification Receives: Behavioral: Vesicare (solifenacin) plus behavioral modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Number of Incontinence Episodes Per 24 Hours Measured by Voiding Diaries.
Measured: 0 week - 12 weeks
Secondary outcomes (1)
Improvement of Symptom Severity
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2009 (estimated)
- Study startSep 2006
- Primary completionSep 2008
- Study completionSep 2008
Why it stopped: Insufficient subject availability/findings for data analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahey Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma US, Inc.
- Responsible party
- Principal investigator, Linda Topjian, Lahey Clinic
- Investigators
- John T Stoffel, M.D., Principal investigator, Lahey Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821184
- Sponsor's protocol ID
- 2006-083
- Status last verified
- Mar 2018
- First submitted
- 9 Jan 2009
- Last updated
- 4 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial of Behavioral Modification and Solifenacin (Vesicare)vs Solifenacin (Vesicare) Alone for the Treatment of Urge Incontinence in Patients With an Overactive Bladder
- ClinicalTrials.gov ID
- NCT00821184
- Acronym / sponsor ID
- 2006-083
- Conditions
- Overactive Bladder
- Keywords
- urinary incontinence, overactive bladder, urinary frequency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient subject availability/findings for data analysis
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Lahey ClinicUniversity, hospital or other
- Collaborators
- Astellas Pharma US, Inc.
- Study start
- Sep 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 13 Jan 2009 (estimated)
- Results
- Posted 30 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vesicare | Active comparator | Drug: Vesicare (solifenacin)Vesicare alone |
| Vesicare/behavioral modification | Active comparator | Behavioral: Vesicare (solifenacin) plus behavioral modificationVesicare plus behavioral modification |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vesicare (solifenacin)5mg po qd | Drug | Vesicare |
| Vesicare (solifenacin) plus behavioral modificationAlso: Vesicare (solifenacin)5 mg dose po once daily plus behavioral modification | Behavioural | Vesicare/behavioral modification |
Primary outcome
Change From Baseline in the Number of Incontinence Episodes Per 24 Hours Measured by Voiding Diaries.
Time frame: 0 week - 12 weeks
1 secondary outcome
Improvement of Symptom Severity
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John T Stoffel, M.D. principal investigator
Lahey Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vesicare (solifenacin) and Vesicare (solifenacin) plus behavioral modification in people with Overactive Bladder, run by Lahey Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the Number of Incontinence Episodes Per 24 Hours Measured by Voiding Diaries. (time frame: 0 week - 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2018.