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

NCT04068025 | Completed

• 1 other identifier: 16.01.2018 18/10
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder; Quality of Life

Keywords

incontinence; male; overactive bladder; quality of life

Outcome Measures

Primary Outcomes (1)

• 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.

  20 minutes before and 6 months after the training

Secondary Outcomes (2)

• The Urogenital Distress Inventory (UDI-6)

  20 minutes before and 6 months after the training

• The Incontinence Impact Questionnaire-7 (IIQ-7)

  20 minutes before and 6 months after the training

Other Outcomes (1)

• The Urinary Incontinence Information Evaluation Form (UIIEF)

  20 minutes before and 6 months after the training

Study Arms (2)

No Intervention: Control group

NO INTERVENTION

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.

the IMB model

ACTIVE COMPARATOR

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

Other: Assigned Interventions

Interventions

Assigned Interventions OTHER

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.

the IMB model

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Ankara Yildirim Beyazit University

Ankara, 06010, Turkey (Türkiye)

Location

Related Publications (23)

• Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.

  PMID: 11857671 BACKGROUND

• Stewart WF, Van Rooyen JB, Cundiff GW, Abrams P, Herzog AR, Corey R, Hunt TL, Wein AJ. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003 May;20(6):327-36. doi: 10.1007/s00345-002-0301-4. Epub 2002 Nov 15.

  PMID: 12811491 BACKGROUND

• Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S, Coyne K, Kelleher C, Hampel C, Artibani W, Abrams P. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol. 2006 Dec;50(6):1306-14; discussion 1314-5. doi: 10.1016/j.eururo.2006.09.019. Epub 2006 Oct 2.

  PMID: 17049716 BACKGROUND

• Irwin DE, Abrams P, Milsom I, Kopp Z, Reilly K; EPIC Study Group. Understanding the elements of overactive bladder: questions raised by the EPIC study. BJU Int. 2008 Jun;101(11):1381-7. doi: 10.1111/j.1464-410X.2008.07573.x. Epub 2008 Mar 10.

  PMID: 18336602 BACKGROUND

• Eapen RS, Radomski SB. Gender differences in overactive bladder. Can J Urol. 2016 Feb;23(Suppl 1):2-9.

  PMID: 26924589 BACKGROUND

• Jeon E, Park HA. Development of the IMB Model and an Evidence-Based Diabetes Self-management Mobile Application. Healthc Inform Res. 2018 Apr;24(2):125-138. doi: 10.4258/hir.2018.24.2.125. Epub 2018 Apr 30.

  PMID: 29770246 BACKGROUND

• Zarani F, Besharat MA, Sarami G, Sadeghian S. An information-motivation-behavioral skills (IMB) model-based intervention for CABG patients. Int J Behav Med. 2012 Dec;19(4):543-9. doi: 10.1007/s12529-011-9193-2.

  PMID: 21948041 BACKGROUND

• Kiene SM, Fisher WA, Shuper PA, Cornman DH, Christie S, Macdonald S, Pillay S, Mahlase G, Fisher JD. Understanding HIV transmission risk behavior among HIV-infected South Africans receiving antiretroviral therapy: an information--motivation--behavioral skills model analysis. Health Psychol. 2013 Aug;32(8):860-8. doi: 10.1037/a0030554. Epub 2013 Mar 11.

  PMID: 23477576 BACKGROUND

• Konkle-Parker DJ, Amico KR, McKinney VE. Effects of an intervention addressing information, motivation, and behavioral skills on HIV care adherence in a southern clinic cohort. AIDS Care. 2014;26(6):674-83. doi: 10.1080/09540121.2013.845283. Epub 2013 Oct 14.

  PMID: 24116922 BACKGROUND

• Uebersax JS, Wyman JF, Shumaker SA, McClish DK, Fantl JA. Short forms to assess life quality and symptom distress for urinary incontinence in women: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program for Women Research Group. Neurourol Urodyn. 1995;14(2):131-9. doi: 10.1002/nau.1930140206.

  PMID: 7780440 BACKGROUND

• Cam C, Sakalli M, Ay P, Cam M, Karateke A. Validation of the short forms of the incontinence impact questionnaire (IIQ-7) and the urogenital distress inventory (UDI-6) in a Turkish population. Neurourol Urodyn. 2007;26(1):129-33. doi: 10.1002/nau.20292.

  PMID: 17083117 BACKGROUND

• Aydin Sayilan A, Ozbas A. The Effect of Pelvic Floor Muscle Training On Incontinence Problems After Radical Prostatectomy. Am J Mens Health. 2018 Jul;12(4):1007-1015. doi: 10.1177/1557988318757242. Epub 2018 Mar 14.

  PMID: 29540090 BACKGROUND

• Shell DF, Newman IM, Perry CM, Folsom AR. Changing intentions to use smokeless tobacco: an application of the IMB model. Am J Health Behav. 2011 Sep;35(5):568-80. doi: 10.5993/ajhb.35.5.6.

  PMID: 22040618 BACKGROUND

• Walsh JL, Senn TE, Scott-Sheldon LA, Vanable PA, Carey MP. Predicting condom use using the Information-Motivation-Behavioral Skills (IMB) model: a multivariate latent growth curve analysis. Ann Behav Med. 2011 Oct;42(2):235-44. doi: 10.1007/s12160-011-9284-y.

  PMID: 21638196 BACKGROUND

• Osborn CY, Egede LE. Validation of an Information-Motivation-Behavioral Skills model of diabetes self-care (IMB-DSC). Patient Educ Couns. 2010 Apr;79(1):49-54. doi: 10.1016/j.pec.2009.07.016. Epub 2009 Aug 21.

  PMID: 19699601 BACKGROUND

• Mittal M, Senn TE, Carey MP. Intimate partner violence and condom use among women: does the information-motivation-behavioral skills model explain sexual risk behavior? AIDS Behav. 2012 May;16(4):1011-9. doi: 10.1007/s10461-011-9949-3.

  PMID: 21484278 BACKGROUND

• Malow RM, Devieux JG, Stein JA, Rosenberg R, Lerner BG, Attonito J, Villalba K. Neurological function, information-motivation-behavioral skills factors, and risk behaviors among HIV-positive alcohol users. AIDS Behav. 2012 Nov;16(8):2297-308. doi: 10.1007/s10461-012-0246-6.

  PMID: 22767030 BACKGROUND

• Ndebele M, Kasese-Hara M, Greyling M. Application of the information, motivation and behavioural skills model for targeting HIV risk behaviour amongst adolescent learners in South Africa. SAHARA J. 2012 Dec;9 Suppl 1:S37-47. doi: 10.1080/17290376.2012.744903.

  PMID: 23234378 BACKGROUND

• Kudo Y. Effectiveness of a condom use educational program developed on the basis of the Information-Motivation-Behavioral Skills model. Jpn J Nurs Sci. 2013 Jun;10(1):24-40. doi: 10.1111/j.1742-7924.2012.00207.x. Epub 2012 Mar 30.

  PMID: 23735087 BACKGROUND

• Ybarra ML, Korchmaros JD, Prescott TL, Birungi R. A Randomized Controlled Trial to Increase HIV Preventive Information, Motivation, and Behavioral Skills in Ugandan Adolescents. Ann Behav Med. 2015 Jun;49(3):473-85. doi: 10.1007/s12160-014-9673-0.

  PMID: 25633626 BACKGROUND

• Ribeiro LH, Prota C, Gomes CM, de Bessa J Jr, Boldarine MP, Dall'Oglio MF, Bruschini H, Srougi M. Long-term effect of early postoperative pelvic floor biofeedback on continence in men undergoing radical prostatectomy: a prospective, randomized, controlled trial. J Urol. 2010 Sep;184(3):1034-9. doi: 10.1016/j.juro.2010.05.040.

  PMID: 20643454 BACKGROUND

• Thuroff JW, Abrams P, Andersson KE, Artibani W, Chapple CR, Drake MJ, Hampel C, Neisius A, Schroder A, Tubaro A. EAU guidelines on urinary incontinence. Eur Urol. 2011 Mar;59(3):387-400. doi: 10.1016/j.eururo.2010.11.021. Epub 2010 Nov 24.

  PMID: 21130559 BACKGROUND

• Nambiar AK, Bosch R, Cruz F, Lemack GE, Thiruchelvam N, Tubaro A, Bedretdinova DA, Ambuhl D, Farag F, Lombardo R, Schneider MP, Burkhard FC. EAU Guidelines on Assessment and Nonsurgical Management of Urinary Incontinence. Eur Urol. 2018 Apr;73(4):596-609. doi: 10.1016/j.eururo.2017.12.031. Epub 2018 Feb 3.

  PMID: 29398262 BACKGROUND

Related Links

• Peyman N, Abdollahi M. Using of information-motivation-behavioral skills model on nutritional behaviors in controlling anemia among girl students. J Research\&Health. 2016; 12

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hilal Tüzer, RN, PhD

  Ankara Yildirim Beyazıt University

  STUDY DIRECTOR

• Elif Gezginci, RN, PhD

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

• Tuba Yılmazer, RN, PhD

  Ankara Yildirim Beyazıt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2019
• First Posted: August 28, 2019
• Study Start: February 1, 2018
• Primary Completion: August 1, 2018
• Study Completion: February 1, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)