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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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
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.
Part 1: Understanding OAB Physiology of bladder Definition, symptom and prevalence of OAB OAB in a treatable condition. There are many options that may help your symptoms. Lifestyle change Medications Bladder training Pelvic floor muscle exercise
Part 2: Behavioral/lifestyle modification Modification of dietary habits Limit bladder irritants- caffeine (coffee, tea, coke...), juice, chemical flavors, spicy food. etc. Altering fluid intake Weight management Learn how weight can affect their condition Stop smoking Constipation management
Part 3: Bladder training Timed voiding- Goal is urinating every 3 or 4 hours during the day without fear of wetting accidents.
Urgency suppression Pelvic muscle contraction, count backwards from 100 by 7seconds, etc Pelvic floor muscle exercise Contraction (fast and slow) and relax the muscle for a count of 3. Repeat the fast and slow contractions 10 - 15 times. Do those at least 3 times a day.
Part 4: Understanding antimuscarinics How the medicine works How to take it Tips that may help manage side effects- dry mouth, constipation Therapy expectations
HEI include 3-day voiding diary for self tracking method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health education intervention (HEI) | Experimental |
| |
| No intervention | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health education intervention (HEI) | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the % of patients maintaining persistence between no intervention and HEI group | Definition of "Maintaining Persistence"= a gap of ≤ 30 days between successive prescription fills | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the % of patients maintaining persistence between no intervention and HEI group | 1, 2 and 4 months | |
| Difference in the % of the patients with the compliance rate ≥ 80% between no intervention and HEI group | Calculation of Compliance (%)= (total no. of drug prescribed - no. of remained drug)/total no. of drug prescribed x 100 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyu-Sung Lee, MD, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bucheon St. Mary's Hospital, The Catholic University of Korea | Bucheon-si | 420-717 | South Korea | |||
| Bucheon Hospital, Soonchunhyang University College of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37811598 | Derived | Funada S, Yoshioka T, Luo Y, Sato A, Akamatsu S, Watanabe N. Bladder training for treating overactive bladder in adults. Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD013571. doi: 10.1002/14651858.CD013571.pub2. |
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| 1, 2, 4, and 6 months |
| Difference in the compliance rate between no intervention and HEI group | 1, 2, 4 and 6 months |
| Difference in changes in OAB symptoms between no intervention and HEI group | OABSS OAB-q short form questionnaire | 1, 2, 4, and 6 months |
| Difference in the treatment satisfaction between no intervention and HEI group | 1, 2, 4, and 6 months |
| Reasons for non-persistence | Definition of non-persistence = a gap of > 30 days between successive prescription fills Examples
| 1, 2, 4, and 6 months |
| Adverse events | 1, 2, 4, and 6 months |
| Bucheon-si |
| 420-767 |
| South Korea |
| Samsung Changwon Hospital, Sungkyunkwan University School of Medicine | Changwon | 630-522 | South Korea |
| Daegu Catholic University College of Medicine | Daegu | 705-034 | South Korea |
| Chungnam National University Hospital | Daejeon | 301-721 | South Korea |
| Chonnam National University Medical School | Gwangju | 501-757 | South Korea |
| Pusan National University Hospital | Pusan | 602-739 | South Korea |
| Cheil General Hospital & Women's Healthcare Center, College of Medicine, Kwandong University | Seoul | 100-380 | South Korea |
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| Yonsei University College of Medicine | Seoul | 120-752 | South Korea |
| Samsung Medical Center, Sungkyunkwan University School of Medicine | Seoul | 135-710 | South Korea |
| Anam Hospital, College of Medicine, Korea University | Seoul | 136-705 | South Korea |
| Asan Medical Center, Ulsan University College of Medicine | Seoul | 138-736 | South Korea |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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