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Information, Motivation, Behavioral Skills Model on Urinary Incontinence and Quality of Life in Men

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ClinicalTrials.gov Identifier: NCT04068025
Recruitment Status : Completed
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Ankara Yildirim Beyazıt University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Quality of Life Other: Assigned Interventions Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : February 1, 2019

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Arms and Interventions
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Arm Intervention/treatment
No Intervention: No Intervention: Control group
Patients in the control group were given usual care by a health professional who was not involved in the study and who worked in the Department of Urology. After the end of the study, the patients in the control group were also given structured bladder training similar to the patients in the intervention group.
Active Comparator: the IMB model
Structured bladder training was applied to the patients in the intervention group via the IMB model.
 Other: Assigned Interventions

Information: In the information step of the bladder training program given through the IMB model, training was given about pelvic floor muscle exercises, bladder program formation, and lifestyle change. The training was conducted face-to-face by the nurse researcher for about 15-20 min, and the training booklet was given to the patients.

Motivation: The patients in the intervention group were interviewed by the nurse researcher by phone or face-to-face in the 1st, 3rd, and 6th months after the training. The patients were motivated by providing information and counseling on the necessary issues. This process was carried out using motivational interviewing principles. Patients were given positive behavioral feedback and encouraged to control urinary incontinence.

Behavioral Skills: Behavioral skills related to urinary incontinence were evaluated 6 months after the training,together with their effects on urinary incontinence symptom score and quality of life.


Outcome Measures
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Primary Outcome Measures :
  1. A Change on Incontinence Severity Measured by The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) [ Time Frame: 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 :
  1. The Urogenital Distress Inventory (UDI-6) [ Time Frame: 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.

  2. The Incontinence Impact Questionnaire-7 (IIQ-7) [ Time Frame: 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.


Other Outcome Measures:
  1. The Urinary Incontinence Information Evaluation Form (UIIEF) [ Time Frame: 20 minutes before and 6 months after the training ]
    Urinary Incontinence Information Evaluation Form (UIIEF) is an information form consisting of 10 multiple choice questions prepared by researchers literature-based and expert opinions. Each item is scored between 0-10 and the total score is calculated in the range of 0-100. The scores obtained from this form provide information about the change of information score means.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04068025


Locations
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Turkey
Ankara Yildirim Beyazit University
Ankara, Turkey, 06010
Sponsors and Collaborators
Ankara Yildirim Beyazıt University
Investigators
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Study Director: Hilal Tüzer, RN, PhD Ankara Yildirim Beyazıt University
Principal Investigator: Elif Gezginci, RN, PhD Saglik Bilimleri Universitesi
Principal Investigator: Tuba Yılmazer, RN, PhD Ankara Yildirim Beyazıt University
More Information
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Additional Information:

Publications:

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Responsible Party: Ankara Yildirim Beyazıt University
ClinicalTrials.gov Identifier: NCT04068025    
Other Study ID Numbers: 16.01.2018 18/10
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ankara Yildirim Beyazıt University:
incontinence
male
overactive bladder
quality of life
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
 Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Urinary Bladder Diseases