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Completed

NCT Number: NCT04688047

Urinary Incontinence and Transtheoretical Model

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.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kutahya Family Health Centers

Kütahya, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nursing care based on the transtheoretical model

Behavioral

Nursing care consists of urinary incontinence training, motivational interview and telephone/mail counseling processes.

Primary outcomes

  1. prevalence of urinary incontinence

    Time frame: Pre-interview (baseline) and last-interview 3 months after pre-interview (change from baseline at 3 months)

    Urinary incontinence according to International Consultation on Incontinence Questionnaire - Short Form

  2. severity of urinary incontinence

    Time frame: Pre-interview (baseline) and last-interview 3 months after pre-interview (change from baseline at 3 months)

    Urinary incontinence severity according to Incontinence Severity Index

Secondary outcomes

  1. Quality of life due to urinary incontinence

    Time frame: Pre-interview (baseline) and last-interview 3 months after pre-interview (change from baseline at 3 months)

    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.

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 29, 2020
Registry last updated
Mar 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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