Behavioural Therapy With Checklist for Overactive Bladder

Not Applicable

Completed

• Conditions: Overactive Bladder
• Interventions: Behavioral: behavioural therapy with written guideline; Drug: Antimuscarinic drugs used in overactive bladder; Behavioral: behavioural therapy with written checklist form to complete

• Registration Number: NCT03662893
• Lead Sponsor: Ankara Training and Research Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2017-12-31
• Study Completion: 2018-04-15
• Status Verified: 2018-09
• Study First Submitted: 2018-09-06
• Study First Submitted QC: 2018-09-07
• Last Update Submitted: 2018-09-07
• Study First Posted: 2018-09-10
• Last Update Posted: 2018-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioural therapy with written guideline	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.
antimuscarinic drug plus verbal behavioural therapy	Antimuscarinic drugs used in overactive bladder	Patients received medical treatment (once or twice per day) plus behavioural therapy without checklist over six-month period.
Behavioural therapy with checklist	behavioural therapy with written checklist form to complete	Patients were instructed to apply behavioural therapy with a written checklist for patients to fully complete over six-month period.
antimuscarinic drug plus verbal behavioural therapy	behavioural therapy with written guideline	Patients received medical treatment (once or twice per day) plus behavioural therapy without checklist over six-month period.
antimuscarinics plus checklist	behavioural therapy with written checklist form to complete	Patients received medical treatment (once or twice per day) with a written checklist to fully complete over six-month period.
antimuscarinics plus checklist	Antimuscarinic drugs used in overactive bladder	Patients received medical treatment (once or twice per day) with a written checklist to fully complete over six-month period.

Primary Outcome Measures

Name	Time	Method
Urinary frequency	6 months	\>8 micturitions per day
Urgency	6 months	\>6 urgency episodes per day

Secondary Outcome Measures

Name	Time	Method
Treatment Benefit Scale	6 months	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''
Urgency urinary incontinence	6 months	\>3 urgency urinary incontinence episodes per day
Nocturia	6 months	\>1 micturition at night

Trial Locations

Locations (1)

Ankara Training and Research Hospital; 🇹🇷 Ankara, Turkey