Behavioural Therapy With Checklist for Overactive Bladder

Checklist to Increase Effectiveness of Behavioural Therapy 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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Behavioral: behavioural therapy with written guideline; Behavioral: behavioural therapy with written checklist form to complete; Drug: Antimuscarinic drugs used in overactive bladder

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06340
    • Ankara Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / 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.	Behavioral: behavioural therapy with written guideline; behavioural therapy with written guideline,which are the same as those in the checklist; Drug: Antimuscarinic drugs used in overactive bladder; Antimuscarinic drugs (Tolterodine, solifenacin, propiverine, darifenacin,fesoterodine)
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary frequency	>8 micturitions per day	6 months
Urgency	>6 urgency episodes per day	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Benefit Scale	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''	6 months
Urgency urinary incontinence	>3 urgency urinary incontinence episodes per day	6 months
Nocturia	>1 micturition at night	6 months

Collaborators and Investigators

• Sponsor: Ankara Training and Research Hospital
• Collaborators: Ministry of Health, Turkey
• Investigators: Study Chair: Koray Agras, Prof, Ankara Training and Research Hospital

Publications and helpful links

General Publications

• Dumoulin C, Hunter KF, Moore K, Bradley CS, Burgio KL, Hagen S, Imamura M, Thakar R, Williams K, Chambers T. Conservative management for female urinary incontinence and pelvic organ prolapse review 2013: Summary of the 5th International Consultation on Incontinence. Neurourol Urodyn. 2016 Jan;35(1):15-20. doi: 10.1002/nau.22677. Epub 2014 Nov 15.
• Gezginci E, Iyigun E, Yilmaz S. Comparison of 3 Different Teaching Methods for a Behavioral Therapy Program for Female Overactive Bladder: A Randomized Controlled Trial. J Wound Ostomy Continence Nurs. 2018 Jan/Feb;45(1):68-74. doi: 10.1097/WON.0000000000000398.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): April 15, 2018

Study Registration Dates

• First Submitted: September 6, 2018
• First Submitted That Met QC Criteria: September 7, 2018
• First Posted (Actual): September 10, 2018

Study Record Updates

• Last Update Posted (Actual): September 10, 2018
• Last Update Submitted That Met QC Criteria: September 7, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: adherence; overactive bladder; behavioural therapy; drug persistence
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Antagonists; Cholinergic Agents; Muscarinic Antagonists
• Other Study ID Numbers: 5002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No