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Behavioural Therapy With Checklist for Overactive Bladder

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ClinicalTrials.gov Identifier: NCT03662893
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : September 10, 2018
Sponsor:
Collaborator:
Ministry of Health, Turkey
Information provided by (Responsible Party):
Muhammet Fatih Kilinc, 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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Behavioral: behavioural therapy with written checklist form to complete Drug: Antimuscarinic drugs used in overactive bladder Behavioral: behavioural therapy with written guideline Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Masking: Single (Outcomes Assessor)
Masking Description: Analysis of treatment response was performed by a single independent urologist blinded to the study groups.
Primary Purpose: Treatment
Official Title: Checklist to Increase Effectiveness of Behavioural Therapy for Overactive Bladder
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : April 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: 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.
Behavioral: behavioural therapy with written guideline
behavioural therapy with written guideline,which are the same as those in the checklist

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

Active Comparator: antimuscarinic drug plus verbal behavioural therapy
Patients received medical treatment (once or twice per day) plus behavioural therapy without checklist over six-month period.
Drug: Antimuscarinic drugs used in overactive bladder
Antimuscarinic drugs (Tolterodine, solifenacin, propiverine, darifenacin,fesoterodine)

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

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

Drug: Antimuscarinic drugs used in overactive bladder
Antimuscarinic drugs (Tolterodine, solifenacin, propiverine, darifenacin,fesoterodine)




Primary Outcome Measures :
  1. Urinary frequency [ Time Frame: 6 months ]
    >8 micturitions per day

  2. Urgency [ Time Frame: 6 months ]
    >6 urgency episodes per day


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662893


Locations
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Turkey
Ankara Training and Research Hospital
Ankara, Turkey, 06340
Sponsors and Collaborators
Ankara Training and Research Hospital
Ministry of Health, Turkey
Investigators
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Study Chair: Koray Agras, Prof Ankara Training and Research Hospital
Publications of Results:
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Responsible Party: Muhammet Fatih Kilinc, Principal Investigator, Ankara Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03662893    
Other Study ID Numbers: 5002
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Muhammet Fatih Kilinc, Ankara Training and Research Hospital:
overactive bladder
behavioural therapy
adherence
drug persistence
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs