Clinical trial NCT04068025: Information, Motivation, Behavioral Skills Model on Urinary Incontinence and Quality of Life in Men
Official title: The Effect of Information, Motivation, Behavioral Skills Model on Urinary Incontinence and Quality of Life in Men With Overactive Bladder: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Quality of Life
Keywords: incontinence
male
overactive bladder
quality of life
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* Male patient
* Over 18 years old
* Overactive Bladder
* Urge urinary incontinence
* Voluntarily agreed to participate in the research

Exclusion Criteria:

* Benign prostatic hyperplasia
* Prostate cancer
* Congenital urinary anomalies
* Neurological or spinal cord injury,
* Diabetes mellitus
* Hypertension
* A mental disability
* Receive medical treatment for incontinence

Primary outcomes:
measure: A Change on Incontinence Severity Measured by The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
timeFrame: 20 minutes before and 6 months after the training
Secondary outcomes:
measure: The Urogenital Distress Inventory (UDI-6)
timeFrame: 20 minutes before and 6 months after the training
measure: The Incontinence Impact Questionnaire-7 (IIQ-7)
timeFrame: 20 minutes before and 6 months after the training
Other outcomes:
measure: The Urinary Incontinence Information Evaluation Form (UIIEF)
timeFrame: 20 minutes before and 6 months after the training
Locations:
city: Ankara
country: Turkey
facility: Ankara Yildirim Beyazit University
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Hilal Tüzer, RN, PhD
role: STUDY_DIRECTOR
affiliation: Saglik Bilimleri Universitesi
name: Elif Gezginci, RN, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara Yildirim Beyazıt University
name: Tuba Yılmazer, RN, PhD
role: PRINCIPAL_INVESTIGATOR
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