Interventions to Enhance Medication Persistence and Compliance in Patients With Overactive Bladder
NCT01515722
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Female aged ≥ 18 years with OAB symptoms for ≥ 3 months
- The sum score of the OABSS ≥ 3 with the score of the question no.3 (urgency) ≥ 2
- The sum score of the OAB V8 ≥ 8
- Any condition that would contraindication of anticholinergic treatment
- Symptomatic acute UTI during the run-in period
- Diagnosed or suspected interstitial cystitis
- Treatment with anticholinergic drugs within 12 months prior to Screening and persist
over 3 months
- Treatment within the 14 days preceding Screening, or expected to initiate treatment
during the study with any other treatment for overactive bladder.
- An indwelling catheter or practicing intermittent self-catheterization
- Pregnant or nursing women
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Québec City, Quebec
- Seoul,
- Daegu,
- Changwon,
- Seoul,
- Bucheon,
- Seoul,
- Bucheon,
- Seoul,
- Seoul,
- Pusan,
- Gwangju,
- Deajeon,
- Seoul,
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Interventions to Enhance Medication Persistence and Compliance in Patients With Overactive Bladder | |||
Official Title ICMJE | Interventions to Enhance Medication Persistence and Compliance in Patients With Overactive Bladder : 6-month, Randomized, Open-label, Multi-center Trial | |||
Brief Summary | Study Objectives: To explore the effectiveness of adjunctive intervention to enhance the medication compliance and persistence in patients with Overactive Bladder (OAB), thereby to improve treatment outcomes Study Hypothesis: Health Education Intervention (HEI) can enhance the medication compliance and persistence, thereby can improve the treatment outcomes in conjunction with pharmacological therapy in OAB patients Study Design: 6-month, randomized, open-label, multi-center trial at 13 university hospitals | |||
Detailed Description | Treatment - Fesoterodine (Toviaz) 4 or 8mg Interventions (2 arms) - Arm 1: No intervention Patients in this arm will not be given HEI in conjunction with pharmacotherapy (Toviaz) which was developed for this trial. - Arm 2: Health education intervention (HEI) HEI will be performed by trained study coordinators with the leaflet designed for this trial composed of 4 parts.
| |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Overactive Bladder | |||
Intervention ICMJE | Behavioral: Health education intervention (HEI)
| |||
Study Arms ICMJE |
| |||
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 | |||
Actual Enrollment ICMJE | 692 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | June 2012 | |||
Actual Primary Completion Date | December 2011 (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 | Korea, Republic of | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01515722 | |||
Other Study ID Numbers ICMJE | 2010-05-106 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Samsung Medical Center | |||
Study Sponsor ICMJE | Samsung Medical Center | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
| |||
PRS Account | Samsung Medical Center | |||
Verification Date | January 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |