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

NCT ID: NCT01515722

Last Updated: 2020-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 692 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2012-06-30

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.

Conditions

Overactive Bladder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Health education intervention (HEI)

Group Type: EXPERIMENTAL

Health education intervention (HEI)

Intervention Type: BEHAVIORAL

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

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Health education intervention (HEI)

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

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyu-Sung Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center, Sungkyunkwan University School of Medicine

Locations

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

Bucheon-si, , South Korea

Bucheon Hospital, Soonchunhyang University College of Medicine

Bucheon-si, , South Korea

Samsung Changwon Hospital, Sungkyunkwan University School of Medicine

Changwon, , South Korea

Daegu Catholic University College of Medicine

Daegu, , South Korea

Chungnam National University Hospital

Daejeon, , South Korea

Chonnam National University Medical School

Gwangju, , South Korea

Pusan National University Hospital

Pusan, , South Korea

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

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Yonsei University College of Medicine

Seoul, , South Korea

Samsung Medical Center, Sungkyunkwan University School of Medicine

Seoul, , South Korea

Anam Hospital, College of Medicine, Korea University

Seoul, , South Korea

Asan Medical Center, Ulsan University College of Medicine

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 37811598 (View on PubMed)

Other Identifiers

2010-05-106

Identifier Type: -

Identifier Source: org_study_id