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

NCT01515722

Last updated date
Study Location
Asan Medical Center, Ulsan University College of Medicine
Seoul, , 138-736, Korea, Republic of
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Overactive Bladder
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Interventions to Enhance Medication Persistence and Compliance in Patients With Overactive Bladder
Official Title  ICMJE Interventions to Enhance Medication Persistence and Compliance in Patients With Overactive Bladder : 6-month, Randomized, Open-label, Multi-center Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Overactive Bladder
Intervention  ICMJE Behavioral: Health education intervention (HEI)
  • <Part 1> Understanding OAB
  • <Part 2> Behavioral/lifestyle modification
  • <Part 3> Bladder training
  • <Part 4> Understanding antimuscarinics
Study Arms  ICMJE
  • Experimental: Health education intervention (HEI)
    Intervention: Behavioral: Health education intervention (HEI)
  • No Intervention: No intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 23, 2012)
692
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01515722
Other Study ID Numbers  ICMJE 2010-05-106
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Samsung Medical Center
Study Sponsor  ICMJE Samsung Medical Center
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Kyu-Sung Lee, MD, PhDSamsung Medical Center, Sungkyunkwan University School of Medicine
PRS Account Samsung Medical Center
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP