Clinical trial NCT03662893: Behavioural Therapy With Checklist for Overactive Bladder
Official title: Checklist to Increase Effectiveness of Behavioural Therapy for Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Keywords: overactive bladder
behavioural therapy
adherence
drug persistence
Lead sponsor: Ankara Training and Research Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Turkey
First posted: 2018-09-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Urinary frequency
timeFrame: 6 months
measure: Urgency
timeFrame: 6 months
Secondary outcomes:
measure: Treatment Benefit Scale
timeFrame: 6 months
measure: Urgency urinary incontinence
timeFrame: 6 months
measure: Nocturia
timeFrame: 6 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Training and Research Hospital
Study officials:
affiliation: Ankara Training and Research Hospital
name: Koray Agras, Prof
role: STUDY_CHAIR
References:
citation: 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.
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.0000000000000398.