Behavioural Therapy With Checklist for Overactive Bladder

Study Overview
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Brief Summary
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The aim of this study is to investigate the efficiency of this newly-established checklist for overactive bladder (OAB) and whether determinate to adherence and persistence rate of combination of behavioural therapy and anticholinergic medications in patients with OAB.

Detailed Description
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Overactive bladder (OAB) can worsen quality of life but it is not life-threatening condition. Although OAB medications effectively decrease disturbing symptoms of OAB, there are a lot of adverse side effects such as dry mouth, cognitive changes, constipation, urinary retention, blurred vision and dyspepsia. Therefore, guidelines have firstly recommended behavioural therapy which are noninvasive and not linked with adverse side effects. These behavioural recommendations include an advice on fluid balance, bladder retraining, urgency suppression or normal voiding techniques, pelvic floor muscle training, caffeine reduction, dietary changes, weight loss and other life style changes to improve lower urinary tract symptoms of OAB. Educational leaflets, verbal or audio-visual instructions and trainings for behavioural therapy have been recommended for patients with OAB, however, to date these beneficial instructions have not been documented as a written checklist. Therefore, they were collected and developed as a written checklist to instruct the patients. The aim of this study was to investigate the efficiency of this newly-established checklist for OAB and whether determinate to adherence and persistence rate of combination of behavioural therapy and anticholinergic medications in patients with OAB.

Official Title
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Checklist to Increase Effectiveness of Behavioural Therapy for Overactive Bladder

Conditions
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Overactive Bladder

Intervention / Treatment
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* Behavioral: behavioural therapy with written checklist form to complete
* Drug: Antimuscarinic drugs used in overactive bladder
* Behavioral: behavioural therapy with written guideline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with >8 micturitions, >1 nocturia, >6 urgency or >3 urgency urinary incontinence episodes per 24 h according to 3-day bladder diary. Exclusion Criteria: active urinary tract infection, a maximum flow rate of 15 ml. per second or less at least 2 uroflow studies, residual volume of 100 cc or more, any medications for OAB, benign prostatic obstruction, polyuria (>3 l per 24 hour), endocrinological disease such as diabetes mellitus or diabetes insipidus which can cause polyuria, neurological or psychological disease disease, prostate or bladder cancer, renal disease, hypertension, genitourinary or congenital abnormality, history of transobturator or transvaginal tape or pelvic organ prolapse surgery pelvic radiation or surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group I were instructed to apply only written guideline forms of behavioural therapy which were the same as those in the checklist, Group II were instructed to apply behavioural therapy with a written checklist for patients to fully complete and Group III received medical treatment plus behavioural therapy without checklist. Group IV received medical treatment with a written checklist to fully complete
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Behavioural therapy with written guideline<br>Patients were instructed to apply only written guideline forms of behavioural therapy which were the same as those in the checklist over six-month period. | Behavioral: behavioural therapy with written guideline<br>* behavioural therapy with written guideline,which are the same as those in the checklist<br>|
| Active Comparator: Behavioural therapy with checklist<br>Patients were instructed to apply behavioural therapy with a written checklist for patients to fully complete over six-month period. | Behavioral: behavioural therapy with written checklist form to complete<br>* Behavioural therapy for overactive bladder such as advice on fluid balance, bladder retraining, urgency suppression or normal voiding techniques, pelvic floor muscle training, caffeine reduction, dietary changes, weight loss and other life style changes<br>|
| Active Comparator: antimuscarinic drug plus verbal behavioural therapy<br>Patients received medical treatment (once or twice per day) plus behavioural therapy without checklist over six-month period. | Drug: Antimuscarinic drugs used in overactive bladder<br>* Antimuscarinic drugs (Tolterodine, solifenacin, propiverine, darifenacin,fesoterodine)<br>Behavioral: behavioural therapy with written guideline<br>* behavioural therapy with written guideline,which are the same as those in the checklist<br>|
| Active Comparator: antimuscarinics plus checklist<br>Patients received medical treatment (once or twice per day) with a written checklist to fully complete over six-month period. | Behavioral: behavioural therapy with written checklist form to complete<br>* Behavioural therapy for overactive bladder such as advice on fluid balance, bladder retraining, urgency suppression or normal voiding techniques, pelvic floor muscle training, caffeine reduction, dietary changes, weight loss and other life style changes<br>Drug: Antimuscarinic drugs used in overactive bladder<br>* Antimuscarinic drugs (Tolterodine, solifenacin, propiverine, darifenacin,fesoterodine)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary frequency | >8 micturitions per day | 6 months | 
| Urgency | >6 urgency episodes per day | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Benefit Scale | Treatment Benefit Scale is consisted of four category including a score of 1 (greatly improved) or 2 (improved) is considered ''yes,'' and a score of 3 (not changed)or 4 (worsened) was considered ''no'' | 6 months | 
| Urgency urinary incontinence | >3 urgency urinary incontinence episodes per day | 6 months | 
| Nocturia | >1 micturition at night | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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overactive bladder, behavioural therapy, adherence, drug persistence