Urinary IncontinenceNCT04688047
Urinary Incontinence and Transtheoretical Model
A study testing Nursing care based on the transtheoretical model in people with Urinary Incontinence, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Nursing care based on the transtheoretical model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Mar 2021to 28 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Urinary Incontinence
- Being tested
- Nursing care based on the transtheoretical model
- Keywords
- Urinary Incontinence, transtheoretical model, motivational interviewing, nursing care
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing care based on the transtheoretical modelBehavioural
Nursing care consists of urinary incontinence training, motivational interview and telephone/mail counseling processes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Nursing care based on the transtheoretical model |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of urinary incontinence
Urinary incontinence according to International Consultation on Incontinence Questionnaire - Short Form
Measured: Pre-interview (baseline) and last-interview 3 months after pre-interview (change from baseline at 3 months)
severity of urinary incontinence
Urinary incontinence severity according to Incontinence Severity Index
Measured: 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.
Measured: Pre-interview (baseline) and last-interview 3 months after pre-interview (change from baseline at 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start22 Mar 2021
- Primary completion26 Sep 2021
- Study completion28 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevil Cicek Ozdemir, Kutahya Health Sciences University
- Investigators
- Ayten Senturk Erenel, Prof., Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688047
- Sponsor's protocol ID
- KutahyaSCO
- Status last verified
- Mar 2023
- First submitted
- 21 Dec 2020
- Last updated
- 20 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Incontinence and Transtheoretical Model
- ClinicalTrials.gov ID
- NCT04688047
- Acronym / sponsor ID
- KutahyaSCO
- Conditions
- Urinary Incontinence
- Keywords
- Urinary Incontinence, transtheoretical model, motivational interviewing, nursing care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 26 Sep 2021 (actual)
- Study completion
- 28 Oct 2021 (actual)
- First posted
- 29 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Nursing care based on the transtheoretical modelWomen 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nursing care based on the transtheoretical modelNursing care consists of urinary incontinence training, motivational interview and telephone/mail counseling processes. | Behavioural | Experimental |
Primary outcome
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
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
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayten Senturk Erenel, Prof. study director
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing care based on the transtheoretical model in people with Urinary Incontinence, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of urinary incontinence (time frame: Pre-interview (baseline) and last-interview 3 months after pre-interview (change from baseline at 3 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.