Clinical trial NCT01515722: Interventions to Enhance Medication Persistence and Compliance in Patients With Overactive Bladder
Official title: Interventions to Enhance Medication Persistence and Compliance in Patients With Overactive Bladder : 6-month, Randomized, Open-label, Multi-center Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Keywords: Medication Persistence
Compliance
Health Education Intervention (HEI)
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2012-01-24
Enrollment: 692
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Difference in the % of patients maintaining persistence between no intervention and HEI group
timeFrame: 6 months
Secondary outcomes:
measure: Difference in the % of patients maintaining persistence between no intervention and HEI group
timeFrame: 1, 2 and 4 months
measure: Difference in the % of the patients with the compliance rate ≥ 80% between no intervention and HEI group
timeFrame: 1, 2, 4, and 6 months
measure: Difference in the compliance rate between no intervention and HEI group
timeFrame: 1, 2, 4 and 6 months
measure: Difference in changes in OAB symptoms between no intervention and HEI group
timeFrame: 1, 2, 4, and 6 months
measure: Difference in the treatment satisfaction between no intervention and HEI group
timeFrame: 1, 2, 4, and 6 months
measure: Reasons for non-persistence
timeFrame: 1, 2, 4, and 6 months
measure: Adverse events
timeFrame: 1, 2, 4, and 6 months
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Bucheon St. Mary's Hospital, The Catholic University of Korea
city: Bucheon
country: Korea, Republic of
facility: Bucheon Hospital, Soonchunhyang University College of Medicine
city: Changwon
country: Korea, Republic of
facility: Samsung Changwon Hospital, Sungkyunkwan University School of Medicine
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University College of Medicine
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Medical School
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Cheil General Hospital & Women's Healthcare Center, College of Medicine, Kwandong University
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center, Sungkyunkwan University School of Medicine
city: Seoul
country: Korea, Republic of
facility: Anam Hospital, College of Medicine, Korea University
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, Ulsan University College of Medicine
Study officials:
affiliation: Samsung Medical Center, Sungkyunkwan University School of Medicine
name: Kyu-Sung Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: