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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Samsung Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01515722
First received: July 22, 2011
Last updated: January 23, 2012
Last verified: January 2012

July 22, 2011
January 23, 2012
December 2010
December 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01515722 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Interventions to Enhance Medication Persistence and Compliance in Patients With Overactive Bladder
Interventions to Enhance Medication Persistence and Compliance in Patients With Overactive Bladder : 6-month, Randomized, Open-label, Multi-center Trial

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.

  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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Overactive Bladder
Behavioral: Health education intervention (HEI)
  • <Part 1> Understanding OAB
  • <Part 2> Behavioral/lifestyle modification
  • <Part 3> Bladder training
  • <Part 4> Understanding antimuscarinics
  • Experimental: Health education intervention (HEI)
    Intervention: Behavioral: Health education intervention (HEI)
  • No Intervention: No intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
692
June 2012
December 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Kyu-Sung Lee, MD, Ph.D 82-2-3410-3554 ksleedr@skku.edu
Korea, Republic of
 
NCT01515722
2010-05-106
Yes
Kyu-Sung Lee/Professor, Samsung Medical Center, Sungkyunkwan University School of Medicine
Samsung Medical Center
Pfizer
Principal Investigator: Kyu-Sung Lee, MD, PhD Samsung Medical Center, Sungkyunkwan University School of Medicine
Samsung Medical Center
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP