The Influence of the Body Posture Correcting Therapy on Pelvic Floor Muscles Function
Primary Purpose
Urinary Incontinence,Stress
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Manual therapy, exercises and education program
Education program
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence,Stress
Eligibility Criteria
Inclusion Criteria:
- stress urinary incontinence (confirmed by a medical examination)
- female
- age between 25 and 45 years old
Exclusion Criteria:
- gynecological, spinal, and abdominal surgery (excluding cesarean delivery)
- menopause
- spinal and pelvis injuries
- chronic diseases of the circulatory and respiratory system
- neurlogical accidance
Sites / Locations
- The rehabilitation clinic PROFEMED
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Body posture correction
Without correction of body posture
Arm Description
Subjects from study group had an education about pelvic floor and additional a six week body posture therapy.
Subjects form control group had only an education about pelvic floor.
Outcomes
Primary Outcome Measures
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)
Change in Oswestry Disability Index (ODI)
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)
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
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
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
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04366557
Brief Title
The Influence of the Body Posture Correcting Therapy on Pelvic Floor Muscles Function
Official Title
The Influence of the Body Posture Correcting Therapy on Pelvic Floor Muscles Function
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
March 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Katarzyna Jórasz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence,Stress
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants divided into two groups (the study and the control)
Masking
Participant
Masking Description
Subjects covered by the assigned number
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Body posture correction
Arm Type
Experimental
Arm Description
Subjects from study group had an education about pelvic floor and additional a six week body posture therapy.
Arm Title
Without correction of body posture
Arm Type
Other
Arm Description
Subjects form control group had only an education about pelvic floor.
Intervention Type
Other
Intervention Name(s)
Manual therapy, exercises and education program
Intervention Description
a six week body posture therapy consisted of manual therapy (once per week) and home exercises; education about pelvic floor
Intervention Type
Other
Intervention Name(s)
Education program
Intervention Description
education about pelvic floor
Primary Outcome Measure Information:
Title
Change in Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)
Description
evaluating the frequency, severity and impact on quality of life (QoL) of urinary incontinence; scoring scale 0-21 (higher scores mean a worse outcome)
Time Frame
6 week (post-treatment)
Title
Change in Oswestry Disability Index (ODI)
Description
level of disability connected with chronic lumbar pain; scoring scale 0-50 (higher scores mean a worse outcome)
Time Frame
6 week (post-treatment)
Title
Change in King's Health Questionnaire (KHQ)
Description
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)
Time Frame
6 week (post-treatment)
Title
Change in sEMG of the pelvic floor muscles
Description
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)
Time Frame
6 week (post-treatment)
Title
Change in manometry of the pelvic floor muscles
Description
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
Time Frame
6 week (post-treatment)
Title
Change in digital palpation of the pelvic floor muscles using PERFECT shame
Description
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
Time Frame
6 week (post-treatment)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
stress urinary incontinence (confirmed by a medical examination)
female
age between 25 and 45 years old
Exclusion Criteria:
gynecological, spinal, and abdominal surgery (excluding cesarean delivery)
menopause
spinal and pelvis injuries
chronic diseases of the circulatory and respiratory system
neurlogical accidance
Facility Information:
Facility Name
The rehabilitation clinic PROFEMED
City
Warsaw
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
The Influence of the Body Posture Correcting Therapy on Pelvic Floor Muscles Function
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