Urinary Incontinence and Transtheoretical Model

Urinary Incontinence Clinical Trial

Official title:

Urinary Incontinence and Transtheoretical Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04688047
• Other study ID #: KutahyaSCO
• Status: Completed
• Phase: N/A
• Start date: March 22, 2021
• Est. completion date: October 28, 2021

Study information

• Verified date: March 2023
• Source: Kutahya Health Sciences University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to evaluate the effectiveness of nursing care given online to women with urinary incontinence based on the Transtheoretical (Change) Model.

Description:

The research was planned as a randomized experimental design with pre-test and post-test control groups. The research will be conducted in Kutahya, Turkey.

A total of seven online interviews will be conducted with the women in the experimental group, one of which is pre-test, one is the last interview where the post-tests are applied, and five of which are motivational. Women in the experimental group were interviewed every 2 weeks and the women will be followed up by phone/mail every 2 weeks. A total of two online interviews will be conducted with women in the control group, one of which is a pre-test interview and one is a final interview where post-tests are applied. No application will be made to women in the control group. All online calls to be made will be conducted via the WhatsApp application.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: October 28, 2021
• Est. primary completion date: September 26, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion criteria

• 18 years or above

• Diagnosis of urinary incontinence according to the International Consultation of Incontinence Questionnaire - Short Form (ICIQ-SF)

• Mild to moderate incontinence according to the Incontinence Severity Index (ISI)

• Having a smartphone

• Using the WhatsApp application

• Being at one of the stages of pre-contemplation, contemplation, preparation, and action according to the evaluation form for stages of change

• Volunteering to participate in the study

Exclusion criteria

• Having risk factors that are thought to affect urinary incontinence (pregnancy; giving birth within the last year; having been diagnosed with recurrent urinary tract infection; having any health problem affecting the muscle and/or nervous system; having been diagnosed with a disease that increases intra-abdominal pressure and causes coughing, such as asthma, chronic obstructive pulmonary disease; using drugs that may cause urinary incontinence, such as diuretics, anticholinergics, antidepressants, antiparkinsonian, antihistamines, sedatives, narcotic analgesics for the past year; having been diagnosed with pelvic organ prolapse; receiving education and treatment for urinary incontinence in the last year)

• Being at the maintenance stage according to the evaluation form for stages of change

• Not volunteering to participate in the study

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

Behavioral:
• Nursing care based on the transtheoretical model
Nursing care consists of urinary incontinence training, motivational interview and telephone/mail counseling processes.

Locations

Country	Name	City	State
Turkey	Kutahya Family Health Centers	Kutahya

Sponsors (1)

Lead Sponsor	Collaborator
Kutahya Health Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of urinary incontinence	Urinary incontinence according to International Consultation on Incontinence Questionnaire - Short Form	Pre-interview (baseline) and last-interview 3 months after pre-interview (change from baseline at 3 months)
Primary	severity of urinary incontinence	Urinary incontinence severity according to Incontinence Severity Index	Pre-interview (baseline) and last-interview 3 months after pre-interview (change from baseline at 3 months)
Secondary	Quality of life due to urinary incontinence	Quality of life due to urinary incontinence according to incontinence quality of life scale Incontinence quality of life scale scale consists of 22 questions in total. The questions are scored between 1 and 5 points. The minimum value that can be obtained from the scale is 22, the maximum value is 110. It is seen that the higher the score in this scale, the higher the quality of life of the individual.	Pre-interview (baseline) and last-interview 3 months after pre-interview (change from baseline at 3 months)