Information, Motivation, Behavioral Skills Model on Urinary Incontinence and Quality of Life in Men
- Conditions
- Quality of LifeOveractive Bladder
- Interventions
- Other: Assigned Interventions
- Registration Number
- NCT04068025
- Lead Sponsor
- Ankara Yildirim Beyazıt University
- Brief Summary
Multiple studies have shown that education based on the IMB model is effective at bringing about health-related behavior change. The IMB model was found to be effective in developing healthy behaviors aimed at maintaining heart health, providing behavior to prevent smoking addiction, diabetes management, correct nutrition in iron deficiency anemia, and using condoms to prevent HIV. There are no studies in the literature regarding the adaptation of the IMB model to behavioral therapy in patients with OAB or urinary incontinence. To address this, there we aimed to investigate the effect of the IMB model on urinary incontinence and quality of life in men with OAB.
- Detailed Description
This study aimed to investigate the effect of the Information, Motivation, Behavioral Skills Model (IMB) on urinary incontinence and quality of life in men with overactive bladder.
This is a single-center, parallel-group, open-label, randomized controlled clinical trial.
This study was conducted between February 2018 and February 2019, with a total of 60 male patients admitted to the urology clinic of a training and research hospital. Patients over the age of 18, male, and with overactive bladder were included in the study.
Participants were randomized into two equal groups: the intervention group (n=30) and control group (n=30). Structured bladder training with the IMB model was applied to the intervention group. This model was not applied to the control group. The primary outcome was the mean score change over the severity of incontinence measured by the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). The other outcomes were measured by the Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire-7 (IIQ-7), and Urinary Incontinence Information Rating scores. All outcome measures were evaluated before and 6 months after the training. Bladder training with IMB model was found to be effective at ameliorating urinary incontinence and improving quality of life in patients with an overactive bladder.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 60
- Male patient
- Over 18 years old
- Overactive Bladder
- Urge urinary incontinence
- Voluntarily agreed to participate in the research
- Benign prostatic hyperplasia
- Prostate cancer
- Congenital urinary anomalies
- Neurological or spinal cord injury,
- Diabetes mellitus
- Hypertension
- A mental disability
- Receive medical treatment for incontinence
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description the IMB model Assigned Interventions Structured bladder training was applied to the patients in the intervention group via the IMB model.
- Primary Outcome Measures
Name Time Method A Change on Incontinence Severity Measured by The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) 20 minutes before and 6 months after the training The primary outcome measure was the mean score change from baseline incontinence severity at 6 months measured by the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). The ICIQ-SF consists of a total of six items, including the birth date, gender and urinary incontinence characteristics. The score range of this scale is 0-21. High scores indicate increased urinary incontinence severity.
- Secondary Outcome Measures
Name Time Method The Urogenital Distress Inventory (UDI-6) 20 minutes before and 6 months after the training UDI-6 is short forms of the scales developed by Uebersax et al. with six and seven questions, respectively. The Turkish validity study of these forms was made by Cam et al., who reported a Cronbach's alpha coefficient for UDI-6 as 0.74. In this study, the Cronbach's alpha coefficient for UDI-6 was 0.786 before training and 0.746 after the training implementations. Each item was scored between zero and 3, and the total score was calculated in the range of zero to 100. Higher scores obtained from these scales indicate that bladder function is worse.
The Incontinence Impact Questionnaire-7 (IIQ-7) 20 minutes before and 6 months after the training IIQ-7 is short forms of the scales developed by Uebersax et al. with six and seven questions, respectively. The Turkish validity study of these forms was made by Cam et al., who reported a Cronbach's alpha coefficient for IIQ-7 as 0.87. In this study, the Cronbach's alpha coefficient for IIQ-7 was 0.933 before training and 0.902 after the training implementations. Each item was scored between zero and 3, and the total score was calculated in the range of zero to 100. Higher scores obtained from these scales indicate that bladder function is worse.
Trial Locations
- Locations (1)
Ankara Yildirim Beyazit University
🇹🇷Ankara, Turkey