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Clinical Trials/NCT03662893
NCT03662893
Completed
Not Applicable

Checklist to Increase Effectiveness of Behavioural Therapy for Overactive Bladder

Ankara Training and Research Hospital1 site in 1 country120 target enrollmentJanuary 1, 2015

Overview

Phase
Not Applicable
Intervention
behavioural therapy with written guideline
Conditions
Overactive Bladder
Sponsor
Ankara Training and Research Hospital
Enrollment
120
Locations
1
Primary Endpoint
Urinary frequency
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2015
End Date
April 15, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ankara Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Muhammet Fatih Kilinc

Principal Investigator

Ankara Training and Research Hospital

Eligibility Criteria

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

Arms & Interventions

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.

Intervention: behavioural therapy with written guideline

Behavioural therapy with checklist

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

Intervention: behavioural therapy with written checklist form to complete

antimuscarinic drug plus verbal behavioural therapy

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

Intervention: Antimuscarinic drugs used in overactive bladder

antimuscarinic drug plus verbal behavioural therapy

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

Intervention: behavioural therapy with written guideline

antimuscarinics plus checklist

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

Intervention: behavioural therapy with written checklist form to complete

antimuscarinics plus checklist

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

Intervention: Antimuscarinic drugs used in overactive bladder

Outcomes

Primary Outcomes

Urinary frequency

Time Frame: 6 months

\>8 micturitions per day

Urgency

Time Frame: 6 months

\>6 urgency episodes per day

Secondary Outcomes

  • Treatment Benefit Scale(6 months)
  • Urgency urinary incontinence(6 months)
  • Nocturia(6 months)

Study Sites (1)

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