- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05410899
Exercise and Pelvic Floor Health Education Program Effectiveness
June 7, 2022 updated by: SEVGİ GAMZE İRİ, Harran University
Investigation of Effectiveness of Pelvic Floor Health Education and Exercise Program Effectiveness on Women With Urinary Incontinence
The aim of the study is investigation of the effectiveness of Pelvic Floor Health Education and exercise program in women with Urinary Incontinence.
Women diagnosed with both stress and mixed type urinary incontinence were included the study.
Pelvic Floor Health Education and exercise program were applied to women for 12 weeks.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Detailed Description
3 group were created; the first group will applied Pelvic floor health education composed presentation about women health,urinary incontinence, teaching anatomy of the pelvic floor and bladder training ,second group will applied both pelvic floor health education and exercise of pelvic floor muscles for 12 weeks and third group will be control group.Women with urinary incontinence were included the study are continued 12 weeks .
First evaluation is done before education and exercise program, and second evaluation in 6.week and last evaluation after 12 weeks exercise and education program.
Study Type
Observational
Enrollment (Anticipated)
96
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Turkey/Şanlıurfa
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Şanlıurfa, Turkey/Şanlıurfa, Turkey
- Harran University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
The ages between 18 -65 women with urinary incontinence, applying pelvic floor muscle exercise
Description
Inclusion Criteria:
- The ages between 18-65 with urinary incontinence
- Volunteer women who can regularly apply the Pelvic floor muscle exercise program
Exclusion Criteria:
- Having pelvic organ prolapse (Stage≥2),
- Women who are in the neonatal and postnatal period (up to 3 months after birth),
- Situations that will prevent evaluation or communication (cognitive problems, etc.).
- Having a neurological disorder,having urinary tract infection,
- Those who received urinary incontinence treatment or had an operation, • Women who have received training on the pelvic floor before
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Pelvic Floor Health Education
Education will compose presentation about women health, urinary incontinence, teaching anatomy of the pelvic floor and bladder training
|
Women with urinary incontinence will done exercise including pelvic floor muscle and will taught pelvic floor muscle anatomy, physiology, disorders, treatment of disease
Other Names:
|
|
Pelvic Floor Health Education and Exercise Program
pelvic floor health education and exercise of pelvic floor muscles for 12 weeks
|
Women with urinary incontinence will done exercise including pelvic floor muscle and will taught pelvic floor muscle anatomy, physiology, disorders, treatment of disease
Other Names:
|
|
Control
This goup will continue routine treatment such as medication usage
|
Women with urinary incontinence will done exercise including pelvic floor muscle and will taught pelvic floor muscle anatomy, physiology, disorders, treatment of disease
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incontinence severity
Time Frame: 3 month
|
urinary incontinence severity changes frequency of incontinence, using Sandvik severity scale quantity of incontinence, type and time of incontinence, also using voiding diary for three days composed of fluid intake time, voiding time, urinary incontinence time and amount
|
3 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Life style
Time Frame: 3 month
|
women with urinary incontinence decrease quality of life,using visual analog scale (VAS) isolation from their environment, trouble with family
|
3 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 4, 2022
Primary Completion (Anticipated)
September 26, 2022
Study Completion (Anticipated)
September 30, 2022
Study Registration Dates
First Submitted
June 6, 2022
First Submitted That Met QC Criteria
June 6, 2022
First Posted (Actual)
June 8, 2022
Study Record Updates
Last Update Posted (Actual)
June 10, 2022
Last Update Submitted That Met QC Criteria
June 7, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Harran üniversitesi
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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