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Completed

NCT Number: NCT03662893

Behavioural Therapy With Checklist for Overactive Bladder

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

behavioural therapy with written checklist form to complete

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

Drug

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

behavioural therapy with written guideline

Behavioral

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

Primary outcomes

  1. Urinary frequency

    Time frame: 6 months

    >8 micturitions per day

  2. Urgency

    Time frame: 6 months

    >6 urgency episodes per day

Secondary outcomes

  1. Treatment Benefit Scale

    Time frame: 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''

  2. Urgency urinary incontinence

    Time frame: 6 months

    >3 urgency urinary incontinence episodes per day

  3. Nocturia

    Time frame: 6 months

    >1 micturition at night

Sponsors and collaborators

Lead sponsor

Ankara Training and Research Hospital

Other

Collaborators

  • Ministry of Health, Turkey

Registry information

Official study title

Checklist to Increase Effectiveness of Behavioural Therapy for Overactive Bladder

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Sep 10, 2018
Registry last updated
Sep 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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