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Behavioural Therapy With Checklist for Overactive Bladder

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
behavioural therapy with written checklist form to complete
Antimuscarinic drugs used in overactive bladder
behavioural therapy with written guideline
Sponsored by
Ankara Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring overactive bladder, behavioural therapy, adherence, drug persistence

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ankara Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Sham Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Behavioural therapy with written guideline

Behavioural therapy with checklist

antimuscarinic drug plus verbal behavioural therapy

antimuscarinics plus checklist

Arm Description

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.

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

Patients received medical treatment (once or twice per day) plus behavioural therapy without checklist over six-month period.

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

Outcomes

Primary Outcome Measures

Urinary frequency
>8 micturitions per day
Urgency
>6 urgency episodes per day

Secondary Outcome Measures

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''
Urgency urinary incontinence
>3 urgency urinary incontinence episodes per day
Nocturia
>1 micturition at night

Full Information

First Posted
September 6, 2018
Last Updated
September 7, 2018
Sponsor
Ankara Training and Research Hospital
Collaborators
Ministry of Health, Turkey
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1. Study Identification

Unique Protocol Identification Number
NCT03662893
Brief Title
Behavioural Therapy With Checklist for Overactive Bladder
Official Title
Checklist to Increase Effectiveness of Behavioural Therapy for Overactive Bladder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
April 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Training and Research Hospital
Collaborators
Ministry of Health, Turkey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
overactive bladder, behavioural therapy, adherence, drug persistence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Analysis of treatment response was performed by a single independent urologist blinded to the study groups.
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioural therapy with written guideline
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Behavioural therapy with checklist
Arm Type
Active Comparator
Arm Description
Patients were instructed to apply behavioural therapy with a written checklist for patients to fully complete over six-month period.
Arm Title
antimuscarinic drug plus verbal behavioural therapy
Arm Type
Active Comparator
Arm Description
Patients received medical treatment (once or twice per day) plus behavioural therapy without checklist over six-month period.
Arm Title
antimuscarinics plus checklist
Arm Type
Active Comparator
Arm Description
Patients received medical treatment (once or twice per day) with a written checklist to fully complete over six-month period.
Intervention Type
Behavioral
Intervention Name(s)
behavioural therapy with written checklist form to complete
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Antimuscarinic drugs used in overactive bladder
Intervention Description
Antimuscarinic drugs (Tolterodine, solifenacin, propiverine, darifenacin,fesoterodine)
Intervention Type
Behavioral
Intervention Name(s)
behavioural therapy with written guideline
Intervention Description
behavioural therapy with written guideline,which are the same as those in the checklist
Primary Outcome Measure Information:
Title
Urinary frequency
Description
>8 micturitions per day
Time Frame
6 months
Title
Urgency
Description
>6 urgency episodes per day
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Treatment Benefit Scale
Description
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''
Time Frame
6 months
Title
Urgency urinary incontinence
Description
>3 urgency urinary incontinence episodes per day
Time Frame
6 months
Title
Nocturia
Description
>1 micturition at night
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Koray Agras, Prof
Organizational Affiliation
Ankara Training and Research Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Ankara Training and Research Hospital
City
Ankara
ZIP/Postal Code
06340
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25400065
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.
Results Reference
result
PubMed Identifier
29300292
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.
Results Reference
result

Learn more about this trial

Behavioural Therapy With Checklist for Overactive Bladder

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