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

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01515722
• Other study ID #: 2010-05-106
• Status: Completed
• Phase: N/A
• Start date: December 2010
• Est. completion date: June 2012

Study information

• Verified date: January 2012
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 692
• Est. completion date: June 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Behavioral:
• Health education intervention (HEI)
<Part 1> Understanding OAB <Part 2> Behavioral/lifestyle modification <Part 3> Bladder training <Part 4> Understanding antimuscarinics

Locations

Country	Name	City	State
Korea, Republic of	Bucheon Hospital, Soonchunhyang University College of Medicine	Bucheon
Korea, Republic of	Bucheon St. Mary's Hospital, The Catholic University of Korea	Bucheon
Korea, Republic of	Samsung Changwon Hospital, Sungkyunkwan University School of Medicine	Changwon
Korea, Republic of	Daegu Catholic University College of Medicine	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Chonnam National University Medical School	Gwangju
Korea, Republic of	Pusan National University Hospital	Pusan
Korea, Republic of	Anam Hospital, College of Medicine, Korea University	Seoul
Korea, Republic of	Asan Medical Center, Ulsan University College of Medicine	Seoul
Korea, Republic of	Cheil General Hospital & Women's Healthcare Center, College of Medicine, Kwandong University	Seoul
Korea, Republic of	Samsung Medical Center, Sungkyunkwan University School of Medicine	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Yonsei University College of Medicine	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Secondary	Difference in the % of patients maintaining persistence between no intervention and HEI group		1, 2 and 4 months
Secondary	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	1, 2, 4, and 6 months
Secondary	Difference in the compliance rate between no intervention and HEI group		1, 2, 4 and 6 months
Secondary	Difference in changes in OAB symptoms between no intervention and HEI group	OABSS OAB-q short form questionnaire	1, 2, 4, and 6 months
Secondary	Difference in the treatment satisfaction between no intervention and HEI group		1, 2, 4, and 6 months
Secondary	Reasons for non-persistence	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)	1, 2, 4, and 6 months
Secondary	Adverse events		1, 2, 4, and 6 months