Interventions to Enhance Medication Persistence and Compliance in Patients With Overactive Bladder

• Difference in the % of patients maintaining persistence between no intervention and HEI group [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  Definition of "Maintaining Persistence"= a gap of ≤ 30 days between successive prescription fills
  
  

• Difference in the % of patients maintaining persistence between no intervention and HEI group [ Time Frame: 1, 2 and 4 months ] [ Designated as safety issue: No ]
  
• Difference in the % of the patients with the compliance rate ≥ 80% between no intervention and HEI group [ Time Frame: 1, 2, 4, and 6 months ] [ Designated as safety issue: No ]
  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 [ Time Frame: 1, 2, 4 and 6 months ] [ Designated as safety issue: No ]
  
• Difference in changes in OAB symptoms between no intervention and HEI group [ Time Frame: 1, 2, 4, and 6 months ] [ Designated as safety issue: No ]
  OABSS OAB-q short form questionnaire
  
  
• Difference in the treatment satisfaction between no intervention and HEI group [ Time Frame: 1, 2, 4, and 6 months ] [ Designated as safety issue: No ]
  
• Reasons for non-persistence [ Time Frame: 1, 2, 4, and 6 months ] [ Designated as safety issue: No ]

  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 [ Time Frame: 1, 2, 4, and 6 months ] [ Designated as safety issue: Yes ]
  

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.