Overactive Bladder
Conditions
Keywords
Medication Persistence, Compliance, Health Education Intervention (HEI)
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.
Interventions
BEHAVIORALHealth education intervention (HEI)
* \<Part 1\> Understanding OAB * \<Part 2\> Behavioral/lifestyle modification * \<Part 3\> Bladder training * \<Part 4\> Understanding antimuscarinics
Sponsors
Pfizer
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 | 1, 2, 4, and 6 months | OABSS OAB-q short form questionnaire |
| Difference in the % of patients maintaining persistence between no intervention and HEI group | 1, 2 and 4 months | — |
| 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) |
| Adverse events | 1, 2, 4, and 6 months | — |
| Difference in the treatment satisfaction between no intervention and HEI group | 1, 2, 4, and 6 months | — |
Countries
South Korea
Outcome results
None listed