Behavioural Therapy Program for Female Overactive Bladder
- Conditions
- Urinary Bladder, Overactive
- Interventions
- Behavioral: Structured training and leafletBehavioral: Structured trainingBehavioral: LeafletBehavioral: Control Group
- Registration Number
- NCT02701010
- Lead Sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 Structured training and leaflet Structured training and leaflet Group 2 Structured training Structured training Group 3 Leaflet Leaflet Group 4 Control Group Control group
- Primary Outcome Measures
Name Time Method Urogenital Distress Inventory (UDI-6) baseline to 6 or 8 weeks improvement in bladder functions at 6-8 weeks of the intervention compared to baseline
Incontinence Impact Questionnaire (IIQ-7) baseline to 6 or 8 weeks improvement in bladder functions at 6-8 weeks of the intervention compared to baseline
- Secondary Outcome Measures
Name Time Method Urinary Incontinence-Specific Quality of Life Instrument (I-QOL) baseline to 6 or 8 weeks positive changes in quality of life at 6-8 weeks of the intervention compared to baseline
Trial Locations
- Locations (1)
Gulhane Military Medical Academy
🇹🇷Ankara, Kecioren, Turkey