Behavioural Therapy With Checklist for Overactive Bladder

Overactive Bladder Clinical Trial

Official title:

Checklist to Increase Effectiveness of Behavioural Therapy for Overactive Bladder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03662893
• Other study ID #: 5002
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: April 15, 2018

Study information

• Verified date: September 2018
• Source: Ankara Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 15, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

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)

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

Locations

Country	Name	City	State
Turkey	Ankara Training and Research Hospital	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
Ankara Training and Research Hospital	Ministry of Health, Turkey

Country where clinical trial is conducted

Turkey, 

References & 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 In — View Citation

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.0000000000 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary frequency	>8 micturitions per day	6 months
Primary	Urgency	>6 urgency episodes per day	6 months
Secondary	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
Secondary	Urgency urinary incontinence	>3 urgency urinary incontinence episodes per day	6 months
Secondary	Nocturia	>1 micturition at night	6 months