Behavioural Therapy With Checklist for Overactive Bladder

Ankara Training and Research Hospital

Status

Completed

Conditions

Overactive Bladder

Treatments

Drug: Antimuscarinic drugs used in overactive bladder

Behavioral: behavioural therapy with written guideline

Behavioral: behavioural therapy with written checklist form to complete

Study type

Interventional

Funder types

Other

Identifiers

NCT03662893

5002

Details and patient eligibility

About

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.

Full description

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.

Enrollment

120 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

120 participants in 4 patient groups

Behavioural therapy with written guideline

Sham Comparator group

Description:

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.

Treatment:

Behavioral: behavioural therapy with written guideline

Behavioural therapy with checklist

Active Comparator group

Description:

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

Treatment:

Behavioral: behavioural therapy with written checklist form to complete

antimuscarinic drug plus verbal behavioural therapy

Active Comparator group

Description:

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