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CompletedNCT04688047Updated Mar 20, 2023

Urinary Incontinence and Transtheoretical Model

An interventional study of Nursing care based on the transtheoretical model in Urinary Incontinence, sponsored by Kutahya Health Sciences University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-03-20.

Sponsored by Kutahya Health Sciences University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
59
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
Female
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Urinary Incontinence

Keywords

  • Urinary Incontinence
  • transtheoretical model
  • motivational interviewing
  • nursing care
03

In context

Urinary Incontinence

1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.

This study's enrollment of 59 is below the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

Kutahya Health Sciences University is the lead sponsor of 209 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
59 participants (actual)

Study arms

  • Experimental
    Experimental

    Women aged 18 and over with urinary incontinence will be taken. 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.

    Behavioral: Nursing care based on the transtheoretical model

  • No intervention
    Control

    Women aged 18 and over with urinary incontinence will be taken. 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.

Interventions

  • BehavioralNursing care based on the transtheoretical model

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

06

What researchers measure

Primary outcomes

  1. prevalence of urinary incontinence

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

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

  2. severity of urinary incontinence

    Urinary incontinence severity according to Incontinence Severity Index

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

Secondary outcomes

  1. 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.

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

07

Study locations

1 site
  • Kutahya Family Health Centers
    Kutahya, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04688047
Lead sponsor
Kutahya Health Sciences University
Responsible party
Sevil Cicek Ozdemir (Research assistant, Kutahya Health Sciences University) — Principal investigator
First posted
Dec 29, 2020
Start date
Mar 22, 2021
Primary completion
Sep 26, 2021
Completion
Oct 28, 2021
Last update
Mar 20, 2023

Study contacts

Ayten Senturk Erenel, Prof.
study director · Gazi University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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