Urinary Incontinence,StressNCT04366557
The Influence of the Body Posture Correcting Therapy on Pelvic Floor Muscles Function
A study testing Manual therapy, exercises and education program and Education program in people with Urinary Incontinence,Stress, run by Katarzyna Jórasz at 1 site in Poland.
Trial summary
The purpose of this study is to assess the influence of the body posture correcting therapy on pelvic floor muscles function and urinary incontinence problem. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Urinary Incontinence,Stress
- What is being tested?
- Manual therapy, exercises and education program and Education program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2019to 31 Mar 2020
- 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 25 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- stress urinary incontinence (confirmed by a medical examination)
- female
- age between 25 and 45 years old
Who cannot join
- gynecological, spinal, and abdominal surgery (excluding cesarean delivery)
- menopause
- spinal and pelvis injuries
- chronic diseases of the circulatory and respiratory system
- neurlogical accidance
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the influence of the body posture correcting therapy on pelvic floor muscles function and urinary incontinence problem.
Read the detailed description
This randomized, controlled study was aimed to asses influence of a six week global posture correction therapy on pelvic floor muscles function and urinary incontinence problem. Participants were randomly divided into two groups. All subjects overcame assessment of pelvic floor muscles (sEMG, manometry and digital) and completed questionnaire about urinary incontinence problem and general health condition connected with lower tract symptoms. Both groups had a pelvic floor education (what is it, where are the pelvic floor muscle, how to correct contract them etc.) Additionally, the study group had a six week therapy focused on body posture correction. Therapy consisted of manual therapy (once per week) and correction exercises.
- Conditions
- Urinary Incontinence,Stress
- Being tested
- Manual therapy, exercises and education program, Education program
- 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.
Manual therapy, exercises and education programOther
a six week body posture therapy consisted of manual therapy (once per week) and home exercises; education about pelvic floor
Education programOther
education about pelvic floor
| Study group | Role | What they receive |
|---|---|---|
| Body posture correction | Experimental | Subjects from study group had an education about pelvic floor and additional a six week body posture therapy. Receives: Other: Manual therapy, exercises and education program |
| Without correction of body posture | Other | Subjects form control group had only an education about pelvic floor. Receives: Other: Education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)
evaluating the frequency, severity and impact on quality of life (QoL) of urinary incontinence; scoring scale 0-21 (higher scores mean a worse outcome)
Measured: 6 week (post-treatment)
Change in Oswestry Disability Index (ODI)
level of disability connected with chronic lumbar pain; scoring scale 0-50 (higher scores mean a worse outcome)
Measured: 6 week (post-treatment)
Change in King's Health Questionnaire (KHQ)
to assess the impact of lower urinary tract symptoms including urinary incontinence on health related quality of life; the questionnarie consists of three parts; scoring scale: I-II part 0-100; III part 0-30 (higher scores mean a worse outcome)
Measured: 6 week (post-treatment)
Change in sEMG of the pelvic floor muscles
using vaginal probe; average maximum voluntary isometric contraction and relaxation (after 5 attempts); unit of measure - mV (microvolts); higher scores mean a better outcome (contraction); higher scores mean the worse outcome (relaxation)
Measured: 6 week (post-treatment)
Change in manometry of the pelvic floor muscles
to assess the pressure levels performed by voluntary contraction of pelvic floor muscles (after 5 attempts); unit of measure - centimeter of water column (cmH2O); higher scores mean the better outcome
Measured: 6 week (post-treatment)
Change in digital palpation of the pelvic floor muscles using PERFECT shame
to assess power of pelvic floor muscles (P) - scoring scale 1-5 (higher is better), endurance (E) - scoring scale (higher is better), the ability to repeat the contraction with maximum strength (R) - scale 1-10 (higer is better); number of fast contractions (F) - scale 1-15 (higher is better); possibility of elevation of perineum (E) - yes/no; co-contraction of another muscles (C) - yes/no; involuntary contraction during coughing (T) - yes/no
Measured: 6 week (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start1 Jan 2019
- Primary completion1 Apr 2019
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence,StressStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants divided into two groups (the study and the control)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Katarzyna Jórasz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Katarzyna Jórasz, Józef Piłsudski University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366557
- Sponsor's protocol ID
- SKE 01-32/2018
- Status last verified
- Apr 2020
- First submitted
- 18 Apr 2020
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of the Body Posture Correcting Therapy on Pelvic Floor Muscles Function
- ClinicalTrials.gov ID
- NCT04366557
- Acronym / sponsor ID
- SKE 01-32/2018
- Conditions
- Urinary Incontinence,Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Katarzyna JóraszUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 29 Apr 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 purpose of this study is to assess the influence of the body posture correcting therapy on pelvic floor muscles function and urinary incontinence problem.
Detailed description
This randomized, controlled study was aimed to asses influence of a six week global posture correction therapy on pelvic floor muscles function and urinary incontinence problem. Participants were randomly divided into two groups. All subjects overcame assessment of pelvic floor muscles (sEMG, manometry and digital) and completed questionnaire about urinary incontinence problem and general health condition connected with lower tract symptoms. Both groups had a pelvic floor education (what is it, where are the pelvic floor muscle, how to correct contract them etc.) Additionally, the study group had a six week therapy focused on body posture correction. Therapy consisted of manual therapy (once per week) and correction exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants divided into two groups (the study and the control)
| Arm | Type | Receives |
|---|---|---|
| Body posture correction | Experimental | Other: Manual therapy, exercises and education programSubjects from study group had an education about pelvic floor and additional a six week body posture therapy. |
| Without correction of body posture | Other | Other: Education programSubjects form control group had only an education about pelvic floor. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- stress urinary incontinence (confirmed by a medical examination)
- female
- age between 25 and 45 years old
Key exclusion criteria (5 listed)
- gynecological, spinal, and abdominal surgery (excluding cesarean delivery)
- menopause
- spinal and pelvis injuries
- chronic diseases of the circulatory and respiratory system
- neurlogical accidance
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 |
|---|---|---|
| Manual therapy, exercises and education programa six week body posture therapy consisted of manual therapy (once per week) and home exercises; education about pelvic floor | Other | Body posture correction |
| Education programeducation about pelvic floor | Other | Without correction of body posture |
Primary outcome
Change in Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)
Time frame: 6 week (post-treatment)
evaluating the frequency, severity and impact on quality of life (QoL) of urinary incontinence; scoring scale 0-21 (higher scores mean a worse outcome)
Change in Oswestry Disability Index (ODI)
Time frame: 6 week (post-treatment)
level of disability connected with chronic lumbar pain; scoring scale 0-50 (higher scores mean a worse outcome)
Change in King's Health Questionnaire (KHQ)
Time frame: 6 week (post-treatment)
to assess the impact of lower urinary tract symptoms including urinary incontinence on health related quality of life; the questionnarie consists of three parts; scoring scale: I-II part 0-100; III part 0-30 (higher scores mean a worse outcome)
Change in sEMG of the pelvic floor muscles
Time frame: 6 week (post-treatment)
using vaginal probe; average maximum voluntary isometric contraction and relaxation (after 5 attempts); unit of measure - mV (microvolts); higher scores mean a better outcome (contraction); higher scores mean the worse outcome (relaxation)
Change in manometry of the pelvic floor muscles
Time frame: 6 week (post-treatment)
to assess the pressure levels performed by voluntary contraction of pelvic floor muscles (after 5 attempts); unit of measure - centimeter of water column (cmH2O); higher scores mean the better outcome
Change in digital palpation of the pelvic floor muscles using PERFECT shame
Time frame: 6 week (post-treatment)
to assess power of pelvic floor muscles (P) - scoring scale 1-5 (higher is better), endurance (E) - scoring scale (higher is better), the ability to repeat the contraction with maximum strength (R) - scale 1-10 (higer is better); number of fast contractions (F) - scale 1-15 (higher is better); possibility of elevation of perineum (E) - yes/no; co-contraction of another muscles (C) - yes/no; involuntary contraction during coughing (T) - yes/no
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 29 Apr 2020.
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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?
A study testing Manual therapy, exercises and education program and Education program in people with Urinary Incontinence,Stress, run by Katarzyna Jórasz at 1 site in Poland.
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 3 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: finished, as of the sponsor's last update on 29 Apr 2020. 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 Poland. 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?
Change in Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF) (time frame: 6 week (post-treatment)). The study lists 6 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 29 Apr 2020.