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

Primary Purpose

Overactive Bladder, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Assigned Interventions
Sponsored by
Ankara Yildirim Beyazıt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Overactive Bladder focused on measuring incontinence, male, overactive bladder, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ankara Yildirim Beyazit University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

No Intervention: Control group

the IMB model

Arm Description

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.

Structured bladder training was applied to the patients in the intervention group via the IMB model.

Outcomes

Primary Outcome Measures

A Change on Incontinence Severity Measured by The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
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

The Urogenital Distress Inventory (UDI-6)
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)
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.

Full Information

First Posted
June 22, 2019
Last Updated
August 22, 2019
Sponsor
Ankara Yildirim Beyazıt University
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1. Study Identification

Unique Protocol Identification Number
NCT04068025
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
February 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ankara Yildirim Beyazıt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Quality of Life
Keywords
incontinence, male, overactive bladder, quality of life

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Intervention: Control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
the IMB model
Arm Type
Active Comparator
Arm Description
Structured bladder training was applied to the patients in the intervention group via the IMB model.
Intervention Type
Other
Intervention Name(s)
Assigned Interventions
Intervention Description
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.
Primary Outcome Measure Information:
Title
A Change on Incontinence Severity Measured by The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
Description
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.
Time Frame
20 minutes before and 6 months after the training
Secondary Outcome Measure Information:
Title
The Urogenital Distress Inventory (UDI-6)
Description
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.
Time Frame
20 minutes before and 6 months after the training
Title
The Incontinence Impact Questionnaire-7 (IIQ-7)
Description
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.
Time Frame
20 minutes before and 6 months after the training
Other Pre-specified Outcome Measures:
Title
The Urinary Incontinence Information Evaluation Form (UIIEF)
Description
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.
Time Frame
20 minutes before and 6 months after the training

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hilal Tüzer, RN, PhD
Organizational Affiliation
Ankara Yildirim Beyazıt University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Elif Gezginci, RN, PhD
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tuba Yılmazer, RN, PhD
Organizational Affiliation
Ankara Yildirim Beyazıt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara Yildirim Beyazit University
City
Ankara
ZIP/Postal Code
06010
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
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Information, Motivation, Behavioral Skills Model on Urinary Incontinence and Quality of Life in Men

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