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

Samsung Medical Center

Status: Completed

Conditions: Overactive Bladder

Treatments: Behavioral: Health education intervention (HEI)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01515722

2010-05-106

Details and patient eligibility

About

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

Full 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.

Enrollment: 692 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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692 participants in 2 patient groups

Health education intervention (HEI)

Experimental group

Treatment:

Behavioral: Health education intervention (HEI)

No intervention

No Intervention group