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Behavioural Therapy Program for Female Overactive Bladder

Primary Purpose

Urinary Bladder, Overactive

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Structured training and leaflet
Structured training
Leaflet
Control Group
Sponsored by
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Bladder, Overactive focused on measuring behavioral therapy, overactive bladder, urinary incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Eligible participants were all ambulatory adults aged 18 or over with predominant iOAB syndrome with or without stress urinary incontinence (the number of urgency and urgency incontinence episodes exceeded the number of stress incontinence episodes and other accidents in bladder diary), who were candidates for behavioural therapy as a first-line treatment after initial clinical assessment, including history, physical examination, symptom questionnaires, 3-day bladder diary, repeated uroflowmetry and postvoid residual measurements for all patients and urodynamics for some patients with a suspicion of presence of the exclusion criteria.

Exclusion criteria were pregnancy, suspected neurogenic disease, stress predominant mixed urinary incontinence, continuous urinary leakage, previous anti-incontinence surgery, voiding dysfunction (PVR> 100 ml), genitourinary malignancies, current or previous behavioural therapy programs, previous or current use of antimuscarinic agents, symptomatic pelvic organ prolapse, severe co-morbidities such as congestive heart failure, chronic renal failure, impaired cognitive functions.

Sites / Locations

  • Gulhane Military Medical Academy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Sham Comparator

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

Structured training and leaflet

Structured training

Leaflet

Control group

Outcomes

Primary Outcome Measures

Urogenital Distress Inventory (UDI-6)
improvement in bladder functions at 6-8 weeks of the intervention compared to baseline
Incontinence Impact Questionnaire (IIQ-7)
improvement in bladder functions at 6-8 weeks of the intervention compared to baseline

Secondary Outcome Measures

Urinary Incontinence-Specific Quality of Life Instrument (I-QOL)
positive changes in quality of life at 6-8 weeks of the intervention compared to baseline

Full Information

First Posted
March 2, 2016
Last Updated
March 4, 2016
Sponsor
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
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1. Study Identification

Unique Protocol Identification Number
NCT02701010
Brief Title
Behavioural Therapy Program for Female Overactive Bladder
Official Title
Comparative Effectiveness of Three Different Teaching Methods in Behavioural Therapy Program for Female Overactive Bladder: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Researchers aimed to identify the effectiveness of three methods of patient education for behavioral therapy (BT), including verbal instructions combined with a leaflet on a structured training program of BT, only verbal instructions on a structured training and only a leaflet on a structured BT training. Therefore, a randomized controlled trial was designed to compare effectiveness of those methods of patient education in BT based on the two validated patient- reported outcome measures (PROMs) for women with overactive bladder. Idiopathic overactive bladder (iOAB) symptoms in female patients are perceived as normal, which does not threaten life and not require to be treated immediately. It is necessary to raise the awareness of iOAB on women. The education and consultancy role of continence nurses is important in the treatment and care of urinary incontinence (UI) associated with iOAB. In the study, it was seen that the training to be provided to patients is helpful regardless of the teaching method used. Also it was found that the method of verbal instructions in the form of a structured training plus giving a leaflet to patient is the most effective method of BT for female iOAB.
Detailed Description
Behavioural therapy (BT) is the first-line treatment for urinary incontinence including idiopathic overactive bladder (iOAB) syndrome. It requires education of the actively participated patient as well as time and effort from the clinician. However, the most effective method for patient education in BT remains unclear. Researchers designed a randomized controlled trial to compare effectiveness of 3 different methods of patient education in BT for women with overactive bladder. The sample of the study consisted of 60 iOAB female patients who applied to urogynecology clinic between November 2012 and April 2013. These patients were equally randomized into 4 groups of teaching models for BT. Group I included the patients educated by a continence nurse's verbal instructions in the form of a structured training including bladder training, bladder control strategies, pelvic floor muscle training and lifestyle changes and a leaflet containing information stated in structured training, group II included the patients taught by a continence nurse as the only verbal structured training, group III included the patients who were given only the leaflet and group IV was the control group consisted of female iOAB patients who were given an unstructured training by a healthcare worker with no specific experience in continence care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder, Overactive
Keywords
behavioral therapy, overactive bladder, urinary incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Structured training and leaflet
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Structured training
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
Leaflet
Arm Title
Group 4
Arm Type
Sham Comparator
Arm Description
Control group
Intervention Type
Behavioral
Intervention Name(s)
Structured training and leaflet
Intervention Description
The patients who were given both "explanatory verbal instructions of the educational leaflet on the structured behavioural therapy for iOAB" by continence nurse and the educational leaflet were included in this group.
Intervention Type
Behavioral
Intervention Name(s)
Structured training
Intervention Description
The patients who were given only "explanatory verbal instructions of the educational leaflet on the structured behavioural therapy" by continence nurse were included in this group.
Intervention Type
Behavioral
Intervention Name(s)
Leaflet
Intervention Description
The patients who were given "only educational leaflet" were included in this group.
Intervention Type
Behavioral
Intervention Name(s)
Control Group
Intervention Description
Patients who were given unstructured explanations about continence care by a healthcare worker were included in control group.
Primary Outcome Measure Information:
Title
Urogenital Distress Inventory (UDI-6)
Description
improvement in bladder functions at 6-8 weeks of the intervention compared to baseline
Time Frame
baseline to 6 or 8 weeks
Title
Incontinence Impact Questionnaire (IIQ-7)
Description
improvement in bladder functions at 6-8 weeks of the intervention compared to baseline
Time Frame
baseline to 6 or 8 weeks
Secondary Outcome Measure Information:
Title
Urinary Incontinence-Specific Quality of Life Instrument (I-QOL)
Description
positive changes in quality of life at 6-8 weeks of the intervention compared to baseline
Time Frame
baseline to 6 or 8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Eligible participants were all ambulatory adults aged 18 or over with predominant iOAB syndrome with or without stress urinary incontinence (the number of urgency and urgency incontinence episodes exceeded the number of stress incontinence episodes and other accidents in bladder diary), who were candidates for behavioural therapy as a first-line treatment after initial clinical assessment, including history, physical examination, symptom questionnaires, 3-day bladder diary, repeated uroflowmetry and postvoid residual measurements for all patients and urodynamics for some patients with a suspicion of presence of the exclusion criteria. Exclusion criteria were pregnancy, suspected neurogenic disease, stress predominant mixed urinary incontinence, continuous urinary leakage, previous anti-incontinence surgery, voiding dysfunction (PVR> 100 ml), genitourinary malignancies, current or previous behavioural therapy programs, previous or current use of antimuscarinic agents, symptomatic pelvic organ prolapse, severe co-morbidities such as congestive heart failure, chronic renal failure, impaired cognitive functions.
Facility Information:
Facility Name
Gulhane Military Medical Academy
City
Ankara
State/Province
Kecioren
ZIP/Postal Code
06010
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
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Behavioural Therapy Program for Female Overactive Bladder

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