Effects of Pelvic Floor Health Education Program in Women With Stress Urinary Incontinence
Primary Purpose
Stress Urinary Incontinence
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Education and booklet
Booklet
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence
Eligibility Criteria
Inclusion Criteria:
- Being between the ages of 18-65
- Women with stress urinary incontinence
- Those who volunteered to participate in the study
- Being literate
Exclusion Criteria:
- Having advanced pelvic organ prolapse
- Having a malignancy
- Having a urinary tract infection
- Those who have a problem that interferes with cooperation and understanding
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Education group
Control group
Arm Description
The education program was given both an educational presentation and a booklet related to the pelvic floor health
The control group will be given a booklet related to the pelvic floor health
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
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".
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".
Full Information
NCT ID
NCT05437666
First Posted
June 27, 2022
Last Updated
June 27, 2022
Sponsor
Ankara Yildirim Beyazıt University
1. Study Identification
Unique Protocol Identification Number
NCT05437666
Brief Title
Effects of Pelvic Floor Health Education Program in Women With Stress Urinary Incontinence
Official Title
Effects of Pelvic Floor Health Education Program in Women With Stress Urinary Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 15, 2022 (Anticipated)
Primary Completion Date
October 15, 2022 (Anticipated)
Study Completion Date
July 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Yildirim Beyazıt University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Education group
Arm Type
Experimental
Arm Description
The education program was given both an educational presentation and a booklet related to the pelvic floor health
Arm Title
Control group
Arm Type
Other
Arm Description
The control group will be given a booklet related to the pelvic floor health
Intervention Type
Other
Intervention Name(s)
Education and booklet
Intervention Description
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.)
Intervention Type
Other
Intervention Name(s)
Booklet
Intervention Description
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.)
Primary Outcome Measure Information:
Title
Presence of urinary incontinence symptoms
Description
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.
Time Frame
change from baseline at 6 weeks
Secondary Outcome Measure Information:
Title
Pelvic floor health knowledge level
Description
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
Time Frame
change from baseline at 6 weeks
Title
Urinary incontinence konwledge level
Description
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.
Time Frame
change from baseline at 6 weeks
Title
Life quality
Description
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".
Time Frame
change from baseline at 6 weeks
Title
Compliance with the program
Description
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".
Time Frame
after program (6th week)
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women with stress urinary incontinence
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Being between the ages of 18-65
Women with stress urinary incontinence
Those who volunteered to participate in the study
Being literate
Exclusion Criteria:
Having advanced pelvic organ prolapse
Having a malignancy
Having a urinary tract infection
Those who have a problem that interferes with cooperation and understanding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seyda Toprak Celenay
Phone
+90312 906 1000
Email
sydtoprak@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seyda Toprak Celenay
Organizational Affiliation
Ankara Yildirim Beyazıt University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Effects of Pelvic Floor Health Education Program in Women With Stress Urinary Incontinence
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