Stress Urinary IncontinenceNCT05437666
Effects of Pelvic Floor Health Education Program in Women With Stress Urinary Incontinence
A study testing Education and booklet and Booklet in people with Stress Urinary Incontinence, run by Ankara Yildirim Beyazıt University.
Trial summary
The aim of this study is to investigate the effects of pelvic floor health education program on urinary incontinence symptoms, knowledge level and quality of life in women with stress urinary incontinence. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Education and booklet and Booklet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2022to 15 Jul 2023
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between the ages of 18-65
- Women with stress urinary incontinence
- Those who volunteered to participate in the study
- Being literate
Who cannot join
- Having advanced pelvic organ prolapse
- Having a malignancy
- Having a urinary tract infection
- Those who have a problem that interferes with cooperation and understanding
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this study is to investigate the effects of pelvic floor health education program on urinary incontinence symptoms, knowledge level and quality of life in women with stress urinary incontinence.
Read the detailed description
Stress urinary incontinence (SUI) is the involuntary urinary incontinence that develops in parallel with the increase in intra-abdominal pressure and is seen in the absence of detrusor contraction. Studies have shown that SUI, leading to a decrease in the quality of life and worsening of social and health conditions, is more common in women than men.
Knowledge of pelvic floor health or urinary incontinence is generally low. Low level of knowledge or wrong information limits patients' access to treatment. Pelvic floor muscle exercise and lifestyle recommendations are also the first treatment options for SUI.
The information and awareness related to the pelvic floor and SUI can be increase and unhealthy behavioral strategies can be modifiable through education programs. Therefore the education programs related to the pelvic floor health would have positive effects on urinary incontinence symptoms, knowledge level and quality of life. Studies about this issue are needed.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Education and booklet, Booklet
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and bookletOther
The education program was given both an educational presentation accompanied by a physiotherapist once a week for six weeks and a booklet related to the pelvic floor health (pelvic floor, urinary incontinence, risk factors, treatment options, healthy behavioral strategies etc.)
BookletOther
The control group will be given a booklet related to the pelvic floor health (pelvic floor, urinary incontinence, risk factors, treatment options, healthy behavioral strategies etc.)
| Study group | Role | What they receive |
|---|---|---|
| Education group | Experimental | The education program was given both an educational presentation and a booklet related to the pelvic floor health Receives: Other: Education and booklet |
| Control group | Other | The control group will be given a booklet related to the pelvic floor health Receives: Other: Booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of urinary incontinence symptoms
International Consultation on Incontinence Questionnaire-Short Form will be used to evaluate the urinary incontinence symptoms. The scale has 6 questions and 4 dimensions (frequency, severity, type of urinary incontinence, and its effect on daily life). The score to be obtained from the scale varies between "0" and "21". As the score increases, the urinary incontinence symptoms also increases.
Measured: change from baseline at 6 weeks
Secondary outcomes (4)
Pelvic floor health knowledge level
Pelvic Floor Health Knowledge Quiz will be used to evaluate the knowledge level of patients about general pelvic floor health. It consists of 3 subscales (function/dysfunction, risk/etiology subscale and diagnosing/treatment) and total 29 questions.
Total score is calculated by summing the number of correct responses, which range between 0 and 29, where a higher score indicates a higher level of knowledge about the pelvic floor health
Measured: change from baseline at 6 weeks
Urinary incontinence konwledge level
The Prolapse Incontinence Knowledge Quiz-urinary incontinence subscale will be used to evaluate the knowledge level of the urinary incontinence. It consists of 12 items. Total score is calculated by summing the number of correct responses, which range between 0 and 12, where a higher score indicates a higher level of knowledge about urinary incontinence.
Measured: change from baseline at 6 weeks
Life quality
King Health Questionnaire will be used to evaluate the life quality. The questionnaire, consisting of thirty-two items, consists of 2 parts. In the first part, there are 2 questions questioning the general health perception and incontinence effect, and 19 questions dividing the quality of life into 7 areas (role limitations, physical limitations, social limitations, personal relationships, emotional problems, sleep/energy disorders, symptom severity measurement). In the second part, there are 11-item complaint severity scales that evaluate the presence and severity of urinary symptoms. While the best score that can be obtained on the complaint severity scale is "0", the worst score is "30", the best score that can be obtained for all King Health Questionnaire subsections is "0" and the worst score is "100".
Measured: change from baseline at 6 weeks
Compliance with the program
Compliance with the program will be evaluated using a 10-cm visual analog scale. 0 point indicates "did not comply with the program" and 10 point indicates " complied with the program".
Measured: after program (6th week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start15 Jul 2022 (estimated)
- Primary completion15 Oct 2022 (estimated)
- Study completion15 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, seyda toprak celenay, Ankara Yildirim Beyazıt University
- Investigators
- Seyda Toprak Celenay, Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437666
- Sponsor's protocol ID
- 2022/06/27
- Status last verified
- Jun 2022
- First submitted
- 27 Jun 2022
- Last updated
- 29 Jun 2022
- 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 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pelvic Floor Health Education Program in Women With Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT05437666
- Acronym / sponsor ID
- 2022/06/27
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 15 Jul 2022 (estimated)
- Primary completion
- 15 Oct 2022 (estimated)
- Study completion
- 15 Jul 2023 (estimated)
- First posted
- 29 Jun 2022 (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 this study is to investigate the effects of pelvic floor health education program on urinary incontinence symptoms, knowledge level and quality of life in women with stress urinary incontinence.
Detailed description
Stress urinary incontinence (SUI) is the involuntary urinary incontinence that develops in parallel with the increase in intra-abdominal pressure and is seen in the absence of detrusor contraction. Studies have shown that SUI, leading to a decrease in the quality of life and worsening of social and health conditions, is more common in women than men.
Knowledge of pelvic floor health or urinary incontinence is generally low. Low level of knowledge or wrong information limits patients' access to treatment. Pelvic floor muscle exercise and lifestyle recommendations are also the first treatment options for SUI.
The information and awareness related to the pelvic floor and SUI can be increase and unhealthy behavioral strategies can be modifiable through education programs. Therefore the education programs related to the pelvic floor health would have positive effects on urinary incontinence symptoms, knowledge level and quality of life. Studies about this issue are needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education group | Experimental | Other: Education and bookletThe education program was given both an educational presentation and a booklet related to the pelvic floor health |
| Control group | Other | Other: BookletThe control group will be given a booklet related to the pelvic floor health |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being between the ages of 18-65
- Women with stress urinary incontinence
- Those who volunteered to participate in the study
- Being literate
Key exclusion criteria (4 listed)
- Having advanced pelvic organ prolapse
- Having a malignancy
- Having a urinary tract infection
- Those who have a problem that interferes with cooperation and understanding
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 |
|---|---|---|
| Education and bookletThe education program was given both an educational presentation accompanied by a physiotherapist once a week for six weeks and a booklet related to the pelvic floor health (pelvic floor, urinary incontinence, risk factors, treatment options, healthy behavioral strategies etc.) | Other | Education group |
| BookletThe control group will be given a booklet related to the pelvic floor health (pelvic floor, urinary incontinence, risk factors, treatment options, healthy behavioral strategies etc.) | Other | Control group |
Primary outcome
Presence of urinary incontinence symptoms
Time frame: change from baseline at 6 weeks
International Consultation on Incontinence Questionnaire-Short Form will be used to evaluate the urinary incontinence symptoms. The scale has 6 questions and 4 dimensions (frequency, severity, type of urinary incontinence, and its effect on daily life). The score to be obtained from the scale varies between "0" and "21". As the score increases, the urinary incontinence symptoms also increases.
4 secondary outcomes
Pelvic floor health knowledge level
Time frame: change from baseline at 6 weeks
Urinary incontinence konwledge level
Time frame: change from baseline at 6 weeks
Life quality
Time frame: change from baseline at 6 weeks
Compliance with the program
Time frame: after program (6th week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
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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.
Seyda Toprak Celenay principal investigator
Ankara Yildirim Beyazıt University
Questions about this trial
What is this clinical trial studying?
A study testing Education and booklet and Booklet in people with Stress Urinary Incontinence, run by Ankara Yildirim Beyazıt University.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seyda Toprak Celenay (+90312 906 1000, sydtoprak@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of urinary incontinence symptoms (time frame: change from baseline at 6 weeks). 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 29 Jun 2022.