Behavioural Therapy With Checklist for Overactive Bladder

NCT03662893 | Completed

• 1 other identifier: 5002
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder

Keywords

overactive bladder; behavioural therapy; adherence; drug persistence

Outcome Measures

Primary Outcomes (2)

• Urinary frequency

  \>8 micturitions per day

  6 months

• Urgency

  \>6 urgency episodes per day

  6 months

Secondary Outcomes (3)

• Treatment Benefit Scale

  6 months

• Urgency urinary incontinence

  6 months

• Nocturia

  6 months

Study Arms (4)

Behavioural therapy with written guideline

SHAM COMPARATOR

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 checklist

ACTIVE COMPARATOR

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

antimuscarinic drug plus verbal behavioural therapy

ACTIVE COMPARATOR

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; Behavioral: behavioural therapy with written guideline

antimuscarinics plus checklist

ACTIVE COMPARATOR

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; Drug: Antimuscarinic drugs used in overactive bladder

Interventions

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

Behavioural therapy with checklist; antimuscarinics plus checklist

Antimuscarinic drugs used in overactive bladder DRUG

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

antimuscarinic drug plus verbal behavioural therapy; antimuscarinics plus checklist

behavioural therapy with written guideline BEHAVIORAL

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

Behavioural therapy with written guideline; antimuscarinic drug plus verbal behavioural therapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with
• \>8 micturitions,
• \>1 nocturia,
• \>6 urgency or
• \>3 urgency urinary incontinence episodes per 24 h according to 3-day bladder diary.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Training and Research Hospital: lead
• Ministry of Health, Turkey: collaborator

Study Sites (1)

Ankara Training and Research Hospital

Ankara, 06340, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 25400065 RESULT

• 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.

  PMID: 29300292 RESULT

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Koray Agras, Prof

  Ankara Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Analysis of treatment response was performed by a single independent urologist blinded to the study groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 10, 2018
• Study Start: January 1, 2015
• Primary Completion: December 31, 2017
• Study Completion: April 15, 2018
• Last Updated: September 10, 2018

Record last verified: 2018-09

Locations

TU (1)