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Completed

NCT Number: NCT01515722

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon-si, South Korea

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About this study

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.

  • 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
  • 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
  • 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.

  • Part 4: Understanding antimuscarinics How the medicine works How to take it Tips that may help manage side effects- dry mouth, constipation Therapy expectations
  • HEI include 3-day voiding diary for self tracking method.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Health education intervention (HEI)

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

Primary outcomes

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

    Time frame: 6 months

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

Secondary outcomes

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

    Time frame: 1, 2 and 4 months

  2. 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

    Calculation of Compliance (%)= (total no. of drug prescribed - no. of remained drug)/total no. of drug prescribed x 100

  3. Difference in the compliance rate between no intervention and HEI group

    Time frame: 1, 2, 4 and 6 months

  4. Difference in changes in OAB symptoms between no intervention and HEI group

    Time frame: 1, 2, 4, and 6 months

    OABSS OAB-q short form questionnaire

  5. Difference in the treatment satisfaction between no intervention and HEI group

    Time frame: 1, 2, 4, and 6 months

  6. Reasons for non-persistence

    Time frame: 1, 2, 4, and 6 months

    Definition of non-persistence = a gap of > 30 days between successive prescription fills

    Examples

    • Insufficient clinical response
    • Adverse event
    • Satisfied with treatment response
    • Laboratory abnormality
    • Subject died
    • Protocol violation
    • Lost to F/U
    • Subject no longer willing to participate in study
    • Pregnancy
    • High patient out-pocket cost
    • Others (provide detailed reason)

  7. Adverse events

    Time frame: 1, 2, 4, and 6 months

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Pfizer

Registry information

Official study title

Interventions to Enhance Medication Persistence and Compliance in Patients With Overactive Bladder : 6-month, Randomized, Open-label, Multi-center Trial

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jan 24, 2012
Registry last updated
Mar 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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