Urinary IncontinencePhase 4NCT00230789
Effect Of Detrol LA With Behavioral Intervention In Overactive Bladder Subjects Dissatisfied With Recent OAB Medication.
A Phase 4 study testing Tolterodine ER 4 mg QD and OAB Patient Behavioral Training Material in people with Urinary Incontinence, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 51 sites in United States.
Trial summary
To evaluate the effect of tolterodine ER in conjunction with behavioral intervention on subject satisfaction in OAB subjects who were dissatisfied with their most recent antimuscarinic OAB medication therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Tolterodine ER 4 mg QD and OAB Patient Behavioral Training Material
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 417 participants
- Where
- 51 sitesUnited States
- Study dates
- Oct 2005to Dec 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects greater than or equal to 18 years of age
- Overactive bladder symptoms for at least 3 months
- Previously treated with antimuscarinic OAB medications
Who cannot join
- Participation in any professionally coached sessions (RN, NP, PA or PT) teaching behavioral interventions
Trial locations and contacts
51 sites in 1 country.
51 sites in 1 country
United States51 sites
Pfizer Investigational Site
Abington, Pennsylvania
Pfizer Investigational Site
Albany, New York
Pfizer Investigational Site
Albuquerque, New Mexico
Pfizer Investigational Site
Bala-Cynwyd, Pennsylvania
Pfizer Investigational Site
Bartlett, Tennessee
Pfizer Investigational Site
Beverly Hills, California
Pfizer Investigational Site
Buena Park, California
Pfizer Investigational Site
Camp Hill, Pennsylvania
Pfizer Investigational Site
Canton, Ohio
Pfizer Investigational Site
Colorado Springs, Colorado
Pfizer Investigational Site
Endwell, New York
Pfizer Investigational Site
Garden City, New York
Pfizer Investigational Site
Greensboro, North Carolina
Pfizer Investigational Site
Hallandale, Florida
Pfizer Investigational Site
Hickory, North Carolina
Pfizer Investigational Site
Houston, Texas
Pfizer Investigational Site
Johnson City, Tennessee
Pfizer Investigational Site
Libertyville, Illinois
Pfizer Investigational Site
Little Rock, Arkansas
Pfizer Investigational Site
Manchester, Missouri
Pfizer Investigational Site
Mattoon, Illinois
Pfizer Investigational Site
Milford, Massachusetts
Pfizer Investigational Site
Mission Viejo, California
Pfizer Investigational Site
Modesto, California
Pfizer Investigational Site
Mountlake Terrace, Washington
Pfizer Investigational Site
Mt. Pleasant, South Carolina
Pfizer Investigational Site
New Tazewell, Tennessee
Pfizer Investigational Site
Newton, Kansas
Pfizer Investigational Site
Norman, Oklahoma
Pfizer Investigational Site
Oceanside, California
Pfizer Investigational Site
Orlando, Florida
Pfizer Investigational Site
Paramount, California
Pfizer Investigational Site
Philadelphia, Pennsylvania
Pfizer Investigational Site
Phoenix, Arizona
Pfizer Investigational Site
Poughkeepsie, New York
Pfizer Investigational Site
Provo, Utah
Pfizer Investigational Site
Raleigh, North Carolina
Pfizer Investigational Site
Sacramento, California
Pfizer Investigational Site
Simpsonville, South Carolina
Pfizer Investigational Site
Spokane, Washington
Pfizer Investigational Site
St Louis, Missouri
Pfizer Investigational Site
Sun Lakes, Arizona
Pfizer Investigational Site
The Bronx, New York
Pfizer Investigational Site
Torrance, California
Pfizer Investigational Site
Tustin, California
Pfizer Investigational Site
Wellington, Florida
Pfizer Investigational Site
Westhampton, New Jersey
Pfizer Investigational Site
Wheat Ridge, Colorado
Pfizer Investigational Site
Williamsport, Pennsylvania
Pfizer Investigational Site
Woodstock, Georgia
Pfizer Investigational Site
Zanesville, Ohio
About this study
Official title: A Multicenter, Multiphase, Single Arm, Open Label Study To Evaluate The Effects Of Tolterodine ER In Conjunction With Behavioral Intervention On Subject Satisfaction And Over- Active Bladder Symptoms (Urgency Urinary Incontinence (UUI), Urgency, Frequency) In Overactive Bladder Subjects Who Were Dissatisfied With Their Most Recent Antimuscarinic OAB Medication Therapy.
To evaluate the effect of tolterodine ER in conjunction with behavioral intervention on subject satisfaction in OAB subjects who were dissatisfied with their most recent antimuscarinic OAB medication therapy.
- Conditions
- Urinary Incontinence
- Being tested
- Tolterodine ER 4 mg QD, OAB Patient Behavioral Training Material
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tolterodine ER 4 mg QDDrug
OAB Patient Behavioral Training MaterialBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject satisfaction with treatment at week 16: Percentage of subjects reporting satisfaction with their current OAB treatment using the Patient Perception of Treatment Satisfaction Question
Secondary outcomes (15)
Percentage of subjects reporting satisfaction (including 'very satisfied' and 'a little satisfied') with their current OAB treatment measured by Patient Perception of Treatment Satisfaction
Percent subjects changed dissatisfied(including'very dissatisfied'and'a little dissatisfied')with OAB week 8 to satisfied(including'very satisfied' and'a little satisfied')with OAB week 16 measured by Patient Perception of Treatment Satisfaction Question
Change in mean number of urgency urinary incontinence episodes at weeks 4, 8, 12 and 16 compared with baseline
Change in mean number of urgency episodes per day at weeks 4, 8, 12 and 16 compared with baseline (Urgency episode defined as micturition episodes associated with Urinary Sensation Scale rating of greater than or equal to 3).
Change in daily urgency micturition rating at weeks 4,8,12 and 16 compared with baseline:Change in mean and sum of Urinary Sensation Scale rating per day
Change in mean number of micturition episodes per 24 hour period and per nocturnal period at weeks 4, 8, 12 and 16 compared with baseline. Means will be based on five dairy days. The following micturition episode parameters will be assessed:
Total micturitions: total number of micturition episodes per time period (24 hour or nocturnal)
OAB micturition: Number of OAB mictruition episodes per time period (24 hour or nocturnal). OAB micturition defined as number of micturition episodes associated with Urinary Sensation Scale ratting of greater than or equal to 3
Severe OAB micturitions in subjects with severe OAB micturition at baseline: Number of severe OAB micturition episodes per time period (24 hour or nocturnal).
Severe OAB micturition episodes defined as number of micturitions associated with a Urinary Sensation Scale rating of greater than or equal to 4
Change in Patient Perception of Bladder Condition (PPBC) at weeks 8 and 16 compared with baseline
Change in Patient Perception of Urgency Scale (PPUS) at weeks 8 and 16 compared with baseline
Change in total Health Related Quality of Life (HRQoL) for Overactive Bladder Questionnaire (OAB-q) and change in scores for each individual domain (symptom bother, coping, concern, sleep, and social function) at weeks 8 and 16 compared with baseline
Reasons for treatment withdrawal.
Adverse events during the 16 week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 417 participants
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00230789
- Sponsor's protocol ID
- A6121146
- Status last verified
- Jan 2021
- First submitted
- 29 Sep 2005
- Last updated
- 27 Jan 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Multiphase, Single Arm, Open Label Study To Evaluate The Effects Of Tolterodine ER In Conjunction With Behavioral Intervention On Subject Satisfaction And Over- Active Bladder Symptoms (Urgency Urinary Incontinence (UUI), Urgency, Frequency) In Overactive Bladder Subjects Who Were Dissatisfied With Their Most Recent Antimuscarinic OAB Medication Therapy.
- ClinicalTrials.gov ID
- NCT00230789
- Acronym / sponsor ID
- A6121146
- Conditions
- Urinary Incontinence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 417 participants
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 3 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effect of tolterodine ER in conjunction with behavioral intervention on subject satisfaction in OAB subjects who were dissatisfied with their most recent antimuscarinic OAB medication therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female subjects greater than or equal to 18 years of age
- Overactive bladder symptoms for at least 3 months
- Previously treated with antimuscarinic OAB medications
Key exclusion criteria (1 listed)
- Participation in any professionally coached sessions (RN, NP, PA or PT) teaching behavioral interventions
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 |
|---|---|---|
| Tolterodine ER 4 mg QD | Drug | – |
| OAB Patient Behavioral Training Material | Behavioural | – |
Primary outcome
Subject satisfaction with treatment at week 16: Percentage of subjects reporting satisfaction with their current OAB treatment using the Patient Perception of Treatment Satisfaction Question
15 secondary outcomes
Percentage of subjects reporting satisfaction (including 'very satisfied' and 'a little satisfied') with their current OAB treatment measured by Patient Perception of Treatment Satisfaction
Percent subjects changed dissatisfied(including'very dissatisfied'and'a little dissatisfied')with OAB week 8 to satisfied(including'very satisfied' and'a little satisfied')with OAB week 16 measured by Patient Perception of Treatment Satisfaction Question
Change in mean number of urgency urinary incontinence episodes at weeks 4, 8, 12 and 16 compared with baseline
Change in mean number of urgency episodes per day at weeks 4, 8, 12 and 16 compared with baseline (Urgency episode defined as micturition episodes associated with Urinary Sensation Scale rating of greater than or equal to 3).
Change in daily urgency micturition rating at weeks 4,8,12 and 16 compared with baseline:Change in mean and sum of Urinary Sensation Scale rating per day
Change in mean number of micturition episodes per 24 hour period and per nocturnal period at weeks 4, 8, 12 and 16 compared with baseline. Means will be based on five dairy days. The following micturition episode parameters will be assessed:
Total micturitions: total number of micturition episodes per time period (24 hour or nocturnal)
OAB micturition: Number of OAB mictruition episodes per time period (24 hour or nocturnal). OAB micturition defined as number of micturition episodes associated with Urinary Sensation Scale ratting of greater than or equal to 3
Severe OAB micturitions in subjects with severe OAB micturition at baseline: Number of severe OAB micturition episodes per time period (24 hour or nocturnal).
Severe OAB micturition episodes defined as number of micturitions associated with a Urinary Sensation Scale rating of greater than or equal to 4
Change in Patient Perception of Bladder Condition (PPBC) at weeks 8 and 16 compared with baseline
Change in Patient Perception of Urgency Scale (PPUS) at weeks 8 and 16 compared with baseline
Change in total Health Related Quality of Life (HRQoL) for Overactive Bladder Questionnaire (OAB-q) and change in scores for each individual domain (symptom bother, coping, concern, sleep, and social function) at weeks 8 and 16 compared with baseline
Reasons for treatment withdrawal.
Adverse events during the 16 week treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
51 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tolterodine ER 4 mg QD and OAB Patient Behavioral Training Material in people with Urinary Incontinence, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 51 sites 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Subject satisfaction with treatment at week 16: Percentage of subjects reporting satisfaction with their current OAB treatment using the Patient Perception of Treatment Satisfaction Question. 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 27 Jan 2021.