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

NCT01515722 | Completed DMC

• 1 other identifier: 2010-05-106
• Study Type: interventional
• Target: 692
• Locations: 1 country
• Sites: 13

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

Conditions

Overactive Bladder

Keywords

Medication Persistence; Compliance; Health Education Intervention (HEI)

Outcome Measures

Primary Outcomes (1)

• Difference in the % of patients maintaining persistence between no intervention and HEI group

  Definition of "Maintaining Persistence"= a gap of ≤ 30 days between successive prescription fills

  6 months

Secondary Outcomes (7)

• Difference in the % of patients maintaining persistence between no intervention and HEI group

  1, 2 and 4 months

• Difference in the % of the patients with the compliance rate ≥ 80% between no intervention and HEI group

  1, 2, 4, and 6 months

• 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

• Difference in the treatment satisfaction between no intervention and HEI group

  1, 2, 4, and 6 months

Study Arms (2)

Health education intervention (HEI)

EXPERIMENTAL

Behavioral: Health education intervention (HEI)

No intervention

NO INTERVENTION

Interventions

Health education intervention (HEI) BEHAVIORAL

* \<Part 1\> Understanding OAB * \<Part 2\> Behavioral/lifestyle modification * \<Part 3\> Bladder training * \<Part 4\> Understanding antimuscarinics

Health education intervention (HEI)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead
• Pfizer: collaborator

Study Sites (13)

Bucheon St. Mary's Hospital, The Catholic University of Korea

Bucheon-si, 420-717, South Korea

Location

Bucheon Hospital, Soonchunhyang University College of Medicine

Bucheon-si, 420-767, South Korea

Location

Samsung Changwon Hospital, Sungkyunkwan University School of Medicine

Changwon, 630-522, South Korea

Location

Daegu Catholic University College of Medicine

Daegu, 705-034, South Korea

Location

Chungnam National University Hospital

Daejeon, 301-721, South Korea

Location

Chonnam National University Medical School

Gwangju, 501-757, South Korea

Location

Pusan National University Hospital

Pusan, 602-739, South Korea

Location

Cheil General Hospital & Women's Healthcare Center, College of Medicine, Kwandong University

Seoul, 100-380, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

Samsung Medical Center, Sungkyunkwan University School of Medicine

Seoul, 135-710, South Korea

Location

Anam Hospital, College of Medicine, Korea University

Seoul, 136-705, South Korea

Location

Asan Medical Center, Ulsan University College of Medicine

Seoul, 138-736, South Korea

Location

Related Publications (1)

• Funada S, Yoshioka T, Luo Y, Sato A, Akamatsu S, Watanabe N. Bladder training for treating overactive bladder in adults. Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD013571. doi: 10.1002/14651858.CD013571.pub2.

  PMID: 37811598 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive; Medication Adherence; Patient Compliance

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Kyu-Sung Lee, MD, PhD

  Samsung Medical Center, Sungkyunkwan University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2011
• First Posted: January 24, 2012
• Study Start: December 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: June 1, 2012
• Last Updated: March 20, 2020

Record last verified: 2012-01

Locations

KR (13)