Behavioural Therapy Program for Female Overactive Bladder

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparative Effectiveness of Three Different Teaching Methods in Behavioural Therapy Program for Female Overactive Bladder: A Randomized Controlled Trial

Conditions
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Urinary Bladder, Overactive

Intervention / Treatment
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* Behavioral: Structured training and leaflet
* Behavioral: Structured training
* Behavioral: Leaflet
* Behavioral: Control Group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Structured training and leaflet | Behavioral: Structured training and leaflet<br>* 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.<br>|
| Active Comparator: Group 2<br>Structured training | Behavioral: Structured training<br>* 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.<br>|
| Active Comparator: Group 3<br>Leaflet | Behavioral: Leaflet<br>* The patients who were given only educational leaflet were included in this group.<br>|
| Sham Comparator: Group 4<br>Control group | Behavioral: Control Group<br>* Patients who were given unstructured explanations about continence care by a healthcare worker were included in control group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urogenital Distress Inventory (UDI-6) | improvement in bladder functions at 6-8 weeks of the intervention compared to baseline | baseline to 6 or 8 weeks | 
| Incontinence Impact Questionnaire (IIQ-7) | improvement in bladder functions at 6-8 weeks of the intervention compared to baseline | baseline to 6 or 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | baseline to 6 or 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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behavioral therapy, overactive bladder, urinary incontinence