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Overactive BladderNCT01515722

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

A study testing Health education intervention (HEI) in people with Overactive Bladder, run by Samsung Medical Center at 13 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Overactive Bladder
What is being tested?
Health education intervention (HEI)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
692 participants
Where
13 sitesSouth Korea
Study dates
Dec 2010to Jun 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

South Korea13 sites

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

    Bucheon-si, 420-717

  • Bucheon Hospital, Soonchunhyang University College of Medicine

    Bucheon-si, 420-767

  • Samsung Changwon Hospital, Sungkyunkwan University School of Medicine

    Changwon, 630-522

  • Daegu Catholic University College of Medicine

    Daegu, 705-034

  • Chungnam National University Hospital

    Daejeon, 301-721

  • Chonnam National University Medical School

    Gwangju, 501-757

  • Pusan National University Hospital

    Pusan, 602-739

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

    Seoul, 100-380

  • Seoul National University Hospital

    Seoul, 110-744

  • Yonsei University College of Medicine

    Seoul, 120-752

  • Samsung Medical Center, Sungkyunkwan University School of Medicine

    Seoul, 135-710

  • Anam Hospital, College of Medicine, Korea University

    Seoul, 136-705

  • Asan Medical Center, Ulsan University College of Medicine

    Seoul, 138-736

Other trials in South Korea

About this study

Official title: 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

Read the 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.
Being tested
Health education intervention (HEI)
Keywords
Medication Persistence, Compliance, Health Education Intervention (HEI)
Medical subject headings
Urinary Bladder, Overactive, Medication Adherence, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health education intervention (HEI)Behavioural

    • <Part 1> Understanding OAB
    • <Part 2> Behavioral/lifestyle modification
    • <Part 3> Bladder training
    • <Part 4> Understanding antimuscarinics
Study groups in NCT01515722
Study groupRoleWhat they receive
Health education intervention (HEI)ExperimentalNot described
Receives: Behavioral: Health education intervention (HEI)
No interventionNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 months

Secondary outcomes (7)

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

    Measured: 1, 2 and 4 months

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

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

    Measured: 1, 2, 4, and 6 months

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

    Measured: 1, 2, 4 and 6 months

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

    OABSS OAB-q short form questionnaire

    Measured: 1, 2, 4, and 6 months

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

    Measured: 1, 2, 4, and 6 months

  6. Reasons for non-persistence

    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)

    Measured: 1, 2, 4, and 6 months

  7. Adverse events

    Measured: 1, 2, 4, and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2012 (estimated)
  2. Study startDec 2010
  3. Primary completionDec 2011
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
692 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01515722
Sponsor's protocol ID
2010-05-106
Status last verified
Jan 2012
First submitted
22 Jul 2011
Last updated
20 Mar 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 37811598

Questions about this trial

What is this clinical trial studying?

A study testing Health education intervention (HEI) in people with Overactive Bladder, run by Samsung Medical Center at 13 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in the % of patients maintaining persistence between no intervention and HEI group (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01515722, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2020.

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