Urinary IncontinenceNCT05410899
Exercise and Pelvic Floor Health Education Program Effectiveness
An observational study of Urinary Incontinence and Pelvic Floor Disorders, run by Harran University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Urinary Incontinence, Pelvic Floor Disorders, Exercise Addiction
- What is being tested?
- exercise
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Jun 2022to 30 Sep 2022
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The ages between 18 -65 women with urinary incontinence, applying pelvic floor muscle exercise
Who may be able to join
- The ages between 18-65 with urinary incontinence
- Volunteer women who can regularly apply the Pelvic floor muscle exercise program
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Harran University Hospital
Sanliurfa, Turkey/Şanlıurfa
About this study
Official title: 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.
Read the 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.
- Being tested
- exercise
- Keywords
- urinary incontinence, exercise, pelvic floor, health education
- Medical subject headings
- Urinary Incontinence, Pelvic Floor Disorders, Motor Activity, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
Also called pelvic floor health education
Women with urinary incontinence will done exercise including pelvic floor muscle and will taught pelvic floor muscle anatomy, physiology, disorders, treatment of disease
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Floor Health Education | Education will compose presentation about women health, urinary incontinence, teaching anatomy of the pelvic floor and bladder training Receives: Other: exercise | |
| Pelvic Floor Health Education and Exercise Program | pelvic floor health education and exercise of pelvic floor muscles for 12 weeks Receives: Other: exercise | |
| Control | This goup will continue routine treatment such as medication usage Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incontinence severity
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
Measured: 3 month
Secondary outcomes (1)
Life style
women with urinary incontinence decrease quality of life,using visual analog scale (VAS) isolation from their environment, trouble with family
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start4 Jun 2022
- Primary completion26 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 96 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SEVGİ GAMZE İRİ, Harran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410899
- Sponsor's protocol ID
- Harran üniversitesi
- Status last verified
- Jun 2022
- First submitted
- 6 Jun 2022
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Effectiveness of Pelvic Floor Health Education and Exercise Program Effectiveness on Women With Urinary Incontinence
- ClinicalTrials.gov ID
- NCT05410899
- Acronym / sponsor ID
- Harran üniversitesi
- Keywords
- urinary incontinence, exercise, pelvic floor, health education
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Study start
- 4 Jun 2022 (actual)
- Primary completion
- 26 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 8 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 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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pelvic Floor Health Education | – | Other: exerciseEducation will compose presentation about women health, urinary incontinence, teaching anatomy of the pelvic floor and bladder training |
| Pelvic Floor Health Education and Exercise Program | – | Other: exercisepelvic floor health education and exercise of pelvic floor muscles for 12 weeks |
| Control | – | Other: exerciseThis goup will continue routine treatment such as medication usage |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The ages between 18 -65 women with urinary incontinence, applying pelvic floor muscle exercise
Key inclusion criteria (2 listed)
- The ages between 18-65 with urinary incontinence
- Volunteer women who can regularly apply the Pelvic floor muscle exercise program
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| exerciseAlso: pelvic floor health educationWomen with urinary incontinence will done exercise including pelvic floor muscle and will taught pelvic floor muscle anatomy, physiology, disorders, treatment of disease | Other | Control, Pelvic Floor Health Education, Pelvic Floor Health Education and Exercise Program |
Primary outcome
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
1 secondary outcome
Life style
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence and Pelvic Floor Disorders, run by Harran 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 2 inclusion and 5 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 10 Jun 2022. 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?
Results are not available in the source record.
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?
Incontinence severity (time frame: 3 month). 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 10 Jun 2022.