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
  Purpose

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


Condition Intervention
Overactive Bladder
Behavioral: Health education intervention (HEI)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Interventions to Enhance Medication Persistence and Compliance in Patients With Overactive Bladder : 6-month, Randomized, Open-label, Multi-center Trial

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 692
Study Start Date: December 2010
Estimated Study Completion Date: June 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Health education intervention (HEI) Behavioral: Health education intervention (HEI)
  • <Part 1> Understanding OAB
  • <Part 2> Behavioral/lifestyle modification
  • <Part 3> Bladder training
  • <Part 4> Understanding antimuscarinics
No Intervention: No intervention

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01515722

Contacts
Contact: Kyu-Sung Lee, MD, Ph.D 82-2-3410-3554 ksleedr@skku.edu

Locations
Korea, Republic of
Bucheon St. Mary's Hospital, The Catholic University of Korea Not yet recruiting
Bucheon, Korea, Republic of, 420-717
Contact: Joon Chul Kim, MD, PhD    82-32-340-7071    kjc@catholic.ac.kr   
Principal Investigator: Joon Chul Kim, MD, PhD         
Bucheon Hospital, Soonchunhyang University College of Medicine Not yet recruiting
Bucheon, Korea, Republic of, 420-767
Contact: Young Ho Kim, MD, PhD    82-32-621-5463    yhkuro@schbc.ac.kr   
Principal Investigator: Young Ho Kim, MD, PhD         
Samsung Changwon Hospital, Sungkyunkwan University School of Medicine Recruiting
Changwon, Korea, Republic of, 630-522
Contact: Young-Suk Lee, MD, PhD    82-55-290-6550    ysuro.lee@samsung.com   
Principal Investigator: Young-Suk Lee, MD, PhD         
Daegu Catholic University College of Medicine Recruiting
Daegu, Korea, Republic of, 705-034
Contact: Duk Yoon Kim, MD, PhD    82-53-650-4663    dykim@cu.ac.kr   
Principal Investigator: Duk Yoon Kim, MD, PhD         
Chungnam National University Hospital Not yet recruiting
Deajeon, Korea, Republic of, 301-721
Contact: Yong Gil Na, MD, PhD    82-42-220-7778    yongna@cnu.ac.kr   
Principal Investigator: Yong Gil Na, MD, PhD         
Chonnam National University Medical School Recruiting
Gwangju, Korea, Republic of, 501-757
Contact: Dong-Deuk Kwon, MD, PhD    82-61-379-7540    urokwon@gmail.com   
Principal Investigator: Dong-Deuk Kwon, MD, PhD         
Pusan National University Hospital Recruiting
Pusan, Korea, Republic of, 602-739
Contact: Jeong Zoo Lee, MD, PhD    82-51-240-7350    toohotman@pusan.ac.kr   
Principal Investigator: Jeong Zoo Lee, MD, PhD         
Asan Medical Center, Ulsan University College of Medicine Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Myung-Soo Choo, MD, PhD    82-2-3010-3735    mschoo@amc.seoul.kr   
Principal Investigator: Myung-Soo Choo, MD, PhD         
Anam Hospital, College of Medicine, Korea University Recruiting
Seoul, Korea, Republic of, 136-705
Contact: Jeong Gu Lee, MD, PhD    82-2-920-5683    jeongkl@kumc.or.kr   
Principal Investigator: Jeong Gu Lee, MD, PhD         
Cheil General Hospital & Women's Healthcare Center, College of Medicine, Kwandong University Not yet recruiting
Seoul, Korea, Republic of, 100-380
Contact: Ju Tae Seo, MD, PhD    82-2-2000-7585    jtandro@cgh.co.kr   
Principal Investigator: Ju Tae Seo, MD, PhD         
Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of, 110-744
Contact: Seung June Oh, MD, PhD    82-2-2072-2406    sjo@snu.ac.kr   
Principal Investigator: Seung June Oh, MD, PhD         
Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Jang Hwan Kim, MD, PhD    82-2-2228-2310    yayanada@hanmail.net   
Principal Investigator: Jang Hwan Kim, MD, PhD         
Samsung Medical Center, Sungkyunkwan University School of Medicine Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Kyu-Sung Lee, MD, PhD    82-2-3410-3554    ksleedr@skku.edu   
Principal Investigator: Kyu-Sung Lee, MD, PhD         
Sponsors and Collaborators
Samsung Medical Center
Pfizer
Investigators
Principal Investigator: Kyu-Sung Lee, MD, PhD Samsung Medical Center, Sungkyunkwan University School of Medicine
  More Information

No publications provided

Responsible Party: Kyu-Sung Lee/Professor, Samsung Medical Center, Sungkyunkwan University School of Medicine
ClinicalTrials.gov Identifier: NCT01515722     History of Changes
Other Study ID Numbers: 2010-05-106
Study First Received: July 22, 2011
Last Updated: January 23, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
Medication Persistence
Compliance
Health Education Intervention (HEI)

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014