Behavioural Therapy With Checklist for Overactive Bladder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2018-04-15

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.

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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.

Conditions

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Analysis of treatment response was performed by a single independent urologist blinded to the study groups.

Study Groups

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Behavioural therapy with written guideline

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.

Group Type SHAM_COMPARATOR

behavioural therapy with written guideline

Intervention Type BEHAVIORAL

behavioural therapy with written guideline,which are the same as those in the checklist

Behavioural therapy with checklist

Patients were instructed to apply behavioural therapy with a written checklist for patients to fully complete over six-month period.

Group Type ACTIVE_COMPARATOR

behavioural therapy with written checklist form to complete

Intervention Type BEHAVIORAL

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

antimuscarinic drug plus verbal behavioural therapy

Patients received medical treatment (once or twice per day) plus behavioural therapy without checklist over six-month period.

Group Type ACTIVE_COMPARATOR

Antimuscarinic drugs used in overactive bladder

Intervention Type DRUG

Antimuscarinic drugs (Tolterodine, solifenacin, propiverine, darifenacin,fesoterodine)

behavioural therapy with written guideline

Intervention Type BEHAVIORAL

behavioural therapy with written guideline,which are the same as those in the checklist

antimuscarinics plus checklist

Patients received medical treatment (once or twice per day) with a written checklist to fully complete over six-month period.

Group Type ACTIVE_COMPARATOR

behavioural therapy with written checklist form to complete

Intervention Type BEHAVIORAL

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

Antimuscarinic drugs used in overactive bladder

Intervention Type DRUG

Antimuscarinic drugs (Tolterodine, solifenacin, propiverine, darifenacin,fesoterodine)

Interventions

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behavioural therapy with written checklist form to complete

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

Intervention Type BEHAVIORAL

Antimuscarinic drugs used in overactive bladder

Antimuscarinic drugs (Tolterodine, solifenacin, propiverine, darifenacin,fesoterodine)

Intervention Type DRUG

behavioural therapy with written guideline

behavioural therapy with written guideline,which are the same as those in the checklist

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No