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

Sponsor

Ankara Yildirim Beyazıt University (Other)

Overall Status

Completed

CT.gov ID

NCT04068025

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder Quality of Life	Other: Assigned Interventions	N/A

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

Study Type:

Interventional

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 :

Feb 1, 2018

Actual Primary Completion Date :

Aug 1, 2018

Actual Study Completion Date :

Feb 1, 2019

Arms and Interventions

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.

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

Primary Outcome Measures

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

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.

Other Outcome Measures

The Urinary Incontinence Information Evaluation Form (UIIEF) [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ankara Yildirim Beyazit University	Ankara		Turkey	06010

Sponsors and Collaborators

Ankara Yildirim Beyazıt University

Investigators

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