Interventions to Enhance Medication Persistence and Compliance in Patients With Overactive Bladder
- Conditions
- Overactive Bladder
- Interventions
- Behavioral: Health education intervention (HEI)
- Registration Number
- NCT01515722
- Lead Sponsor
- Samsung Medical Center
- 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.
1. 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
2. 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
3. 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.
4. Part 4: Understanding antimuscarinics How the medicine works How to take it Tips that may help manage side effects- dry mouth, constipation Therapy expectations
5. HEI include 3-day voiding diary for self tracking method.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 692
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Health education intervention (HEI) Health education intervention (HEI) -
- Primary Outcome Measures
Name Time Method Difference in the % of patients maintaining persistence between no intervention and HEI group 6 months Definition of "Maintaining Persistence"= a gap of ≤ 30 days between successive prescription fills
- Secondary Outcome Measures
Name Time Method Difference in the compliance rate between no intervention and HEI group 1, 2, 4 and 6 months Adverse events 1, 2, 4, and 6 months Difference in the % of patients maintaining persistence between no intervention and HEI group 1, 2 and 4 months Difference in changes in OAB symptoms between no intervention and HEI group 1, 2, 4, and 6 months OABSS OAB-q short form questionnaire
Difference in the treatment satisfaction between no intervention and HEI group 1, 2, 4, and 6 months Difference in the % of the patients with the compliance rate ≥ 80% between no intervention and HEI group 1, 2, 4, and 6 months Calculation of Compliance (%)= (total no. of drug prescribed - no. of remained drug)/total no. of drug prescribed x 100
Reasons for non-persistence 1, 2, 4, and 6 months Definition of non-persistence = a gap of \> 30 days between successive prescription fills
Examples
1. Insufficient clinical response
2. Adverse event
3. Satisfied with treatment response
4. Laboratory abnormality
5. Subject died
6. Protocol violation
7. Lost to F/U
8. Subject no longer willing to participate in study
9. Pregnancy
10. High patient out-pocket cost
11. Others (provide detailed reason)
Trial Locations
- Locations (13)
Bucheon St. Mary's Hospital, The Catholic University of Korea
🇰🇷Bucheon, Korea, Republic of
Bucheon Hospital, Soonchunhyang University College of Medicine
🇰🇷Bucheon, Korea, Republic of
Samsung Changwon Hospital, Sungkyunkwan University School of Medicine
🇰🇷Changwon, Korea, Republic of
Chonnam National University Medical School
🇰🇷Gwangju, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Pusan National University Hospital
🇰🇷Pusan, Korea, Republic of
Cheil General Hospital & Women's Healthcare Center, College of Medicine, Kwandong University
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Yonsei University College of Medicine
🇰🇷Seoul, Korea, Republic of
Asan Medical Center, Ulsan University College of Medicine
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center, Sungkyunkwan University School of Medicine
🇰🇷Seoul, Korea, Republic of
Anam Hospital, College of Medicine, Korea University
🇰🇷Seoul, Korea, Republic of
Daegu Catholic University College of Medicine
🇰🇷Daegu, Korea, Republic of