Overactive BladderPhase 4NCT00759577
Feasibility of "At-home" Titration of Solifenacin
A Phase 4 study testing Solifenacin in people with Overactive Bladder, run by NYU Langone Health.
Trial summary
This is an open-label single center trial to study improvements in symptom bother and quality of life in overactive bladder patients self titrating solifenacin 5mg and 10 mg. The study is designed to reflect real world conditions in typical male and female OAB patients presenting for treatment. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Solifenacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to May 2010
- Phase
- Phase 4
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ambulatory male or female patients aged ≥18 years of age and able to use the toilet without difficulty.
- Symptoms of OAB for > 3 months.
- Written informed consent (IC) has been obtained.
- Capable of filling out questionnaires.
- Patients may be included if they were never exposed to anticholinergic agents specified for the treatment of OAB. Patients may also be included if they have previously been treated with FDA-approved anticholinergic agents for the treatment of OAB such as oxybutynin chloride (generic oxybutynin chloride, Ditropan XL®, Ditropan®, or OxytrolTM), tolterodine tartrate (Detrol® or Detrol LA®), or trospium chloride (Sanctura®, Sanctura XR®) and are no longer receiving such treatment for at least 14 days.
- Patients undergoing non-medical treatments for OAB (pelvic floor exercises or any behavioral modification) must have had treatment initiated at least 4 weeks prior to enrollment and should not change regimen.
- Normal urine analysis or sterile urine specimen (culture negative)
Who cannot join
- Previous treatment with darifenacin
- Duration of urgency with or without urge incontinence, usually accompanied with frequency and nocturia for <3 months
- Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the Investigator
- Evidence of a urinary tract infection (UTI); chronic inflammation such as interstitial cystitis and bladder stones
- Clinically significant outflow obstruction (benign prostatic hyperplasia [BPH]) as determined by the Investigator.
- Uncontrolled narrow angle glaucoma, urinary or gastric retention
Show all 14Show fewer
- All patients with severe renal or hepatic impairment will be excluded from the trial; dose increases to 10mg are not permitted for patients that have moderate hepatic impairment as evidenced by liver function testing.
- Women of childbearing potential who are pregnant or intend to become pregnant during the study or who are sexually active and practicing an unreliable method of birth control, as judged by the Investigator, or will be lactating during the study.
- A history of bladder cancer
- Known or suspected hypersensitivity to solifenacin succinate, any of its components (lactose monohydrate, corn starch, hypromellose 2910, magnesium stearate, talc, polyethylene glycol 8000 and titanium dioxide with yellow ferric oxide [5mg tablet] or red ferric oxide [10 mg tablet]), or other anticholinergics.
- Participation in any clinical trial (except patient registry trial) involving an investigational drug, within 30 days prior to enrollment
- Patients with chronic severe constipation or history of diagnosed gastrointestinal disease obstruction.
- Patients with hematuria.
- Any clinical condition, which, in the opinion of the Investigator, would not allow safe completion of the study.
About this study
Official title: Feasibility of "At-home" Titration of Solifenacin 5 and 10mg and Effect on Symptoms and Quality of Life in a Typical OAB Population
This is an open-label single center trial to study improvements in symptom bother and quality of life in overactive bladder patients self titrating solifenacin 5mg and 10 mg. The study is designed to reflect real world conditions in typical male and female OAB patients presenting for treatment.
Read the detailed description
Open-label single center trial to study improvements in symptom bother and quality of life in OAB patients self titrating solifenacin 5mg and 10 mg. The study was designed to reflect real world conditions in typical male and female OAB patients presenting for treatment. After eligibility was confirmed, subjects completed a number of questionnaires which include patient perception of bladder condition (PPBC)12, Overactive Bladder Questionaire (OAB-q13), visual analog scale (VAS) 0-100 assessing bother of urge incontinence, urgency, frequency and nocturia over the past week.
- Conditions
- Overactive Bladder
- Being tested
- Solifenacin
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SolifenacinDrug
Also called Vesicare
5mg and 10 mg, oral once daily
| Study group | Role | What they receive |
|---|---|---|
| Home titration | Other | Patients were given drug to self titrate Receives: Drug: Solifenacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Patient Perception of Bladder Condition Score (PPBC)
Difference in Patient Perception of Bladder Condition (PPBC) score from start of medication to end of trial (12 weeks). This is a single item patient reported global question that assesses a patients subjective impression of the current urinary problems. The patients is asked to rate their perceived bladder condition on a 6 point scale ranging from 1 (no problem) at all to 6 (many severe problems). To assess change in PPBC the baseline value is subtracted from the end of study value. Thus changes in score typically range from -2 to 2. Negative values represent an improvement.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionMay 2010
- Study completionMay 2010
Why it stopped: difficulty with enrollment
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.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Brucker, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00759577
- Sponsor's protocol ID
- VESI-8E01
- Status last verified
- Oct 2015
- First submitted
- 24 Sep 2008
- Last updated
- 26 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of "At-home" Titration of Solifenacin 5 and 10mg and Effect on Symptoms and Quality of Life in a Typical OAB Population
- ClinicalTrials.gov ID
- NCT00759577
- Acronym / sponsor ID
- VESI-8E01
- Conditions
- Overactive Bladder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty with enrollment
- Enrolment
- 36 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 25 Sep 2008 (estimated)
- Results
- Posted 30 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label single center trial to study improvements in symptom bother and quality of life in overactive bladder patients self titrating solifenacin 5mg and 10 mg. The study is designed to reflect real world conditions in typical male and female OAB patients presenting for treatment.
Detailed description
Open-label single center trial to study improvements in symptom bother and quality of life in OAB patients self titrating solifenacin 5mg and 10 mg. The study was designed to reflect real world conditions in typical male and female OAB patients presenting for treatment. After eligibility was confirmed, subjects completed a number of questionnaires which include patient perception of bladder condition (PPBC)12, Overactive Bladder Questionaire (OAB-q13), visual analog scale (VAS) 0-100 assessing bother of urge incontinence, urgency, frequency and nocturia over the past week.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home titration | Other | Drug: SolifenacinPatients were given drug to self titrate |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ambulatory male or female patients aged ≥18 years of age and able to use the toilet without difficulty.
- Symptoms of OAB for > 3 months.
- Written informed consent (IC) has been obtained.
- Capable of filling out questionnaires.
- Patients may be included if they were never exposed to anticholinergic agents specified for the treatment of OAB. Patients may also be included if they have previously been treated with FDA-approved anticholinergic agents for the treatment of OAB such as oxybutynin chloride (generic oxybutynin chloride, Ditropan XL®, Ditropan®, or OxytrolTM), tolterodine tartrate (Detrol® or Detrol LA®), or trospium chloride (Sanctura®, Sanctura XR®) and are no longer receiving such treatment for at least 14 days.
Key exclusion criteria (14 listed)
- Previous treatment with darifenacin
- Duration of urgency with or without urge incontinence, usually accompanied with frequency and nocturia for <3 months
- Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the Investigator
- Evidence of a urinary tract infection (UTI); chronic inflammation such as interstitial cystitis and bladder stones
- Clinically significant outflow obstruction (benign prostatic hyperplasia [BPH]) as determined by the Investigator.
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 |
|---|---|---|
| SolifenacinAlso: Vesicare5mg and 10 mg, oral once daily | Drug | Home titration |
Primary outcome
Improvement in Patient Perception of Bladder Condition Score (PPBC)
Time frame: 12 weeks
Difference in Patient Perception of Bladder Condition (PPBC) score from start of medication to end of trial (12 weeks). This is a single item patient reported global question that assesses a patients subjective impression of the current urinary problems. The patients is asked to rate their perceived bladder condition on a 6 point scale ranging from 1 (no problem) at all to 6 (many severe problems). To assess change in PPBC the baseline value is subtracted from the end of study value. Thus changes in score typically range from -2 to 2. Negative values represent an improvement.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Overactive Bladder
RecruitingObservational study
Tensi+ European Post-Market Clinical Follow-Up
Overactive Bladder
Not yet recruiting
Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke
Stroke, Neurogenic Overactive Bladder
Not yet recruiting
Parasacral TENS Project
Overactive Bladder (OAB), Lower Urinary Tract Dysfunction
Active, not recruiting
INTIBIA Pivotal Study
Urinary Incontinence, Urge, Urinary Bladder, Overactive
Recruiting
A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)
Overactive Bladder, Urge Incontinence
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Solifenacin in people with Overactive Bladder, run by NYU Langone Health.
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 7 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 26 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 May 2012). 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?
Improvement in Patient Perception of Bladder Condition Score (PPBC) (time frame: 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 26 Oct 2015.