Effect Of Detrol LA With Behavioral Intervention In Overactive Bladder Subjects Dissatisfied With Recent OAB Medication.
NCT00230789
ABOUT THIS STUDY
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- 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
- Participation in any professionally coached sessions (RN, NP, PA or PT) teaching
behavioral interventions
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Descriptive Information | ||||
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Brief Title ICMJE | Effect Of Detrol LA With Behavioral Intervention In Overactive Bladder Subjects Dissatisfied With Recent OAB Medication. | |||
Official Title ICMJE | 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. | |||
Brief 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Urinary Incontinence | |||
Intervention ICMJE |
| |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | 417 | |||
Original Enrollment ICMJE | 400 | |||
Actual Study Completion Date ICMJE | December 2006 | |||
Actual Primary Completion Date | December 2006 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00230789 | |||
Other Study ID Numbers ICMJE | A6121146 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | |||
Study Sponsor ICMJE | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | January 2021 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |