Urinary Bladder, Overactive Clinical Trial
Official title:
Comparative Effectiveness of Three Different Teaching Methods in Behavioural Therapy Program for Female Overactive Bladder: A Randomized Controlled Trial
Verified date | March 2016 |
Source | Gulhane Military Medical Academy |
Contact | n/a |
Is FDA regulated | No |
Health authority | Turkey: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | May 2013 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Turkey | Gulhane Military Medical Academy | Ankara | Kecioren |
Lead Sponsor | Collaborator |
---|---|
Gulhane Military Medical Academy |
Turkey,
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | 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 | No |
Secondary | 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 | No |
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