The Influence of the Body Posture Correcting Therapy on Pelvic Floor Muscles Function

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence,Stress
• Intervention / Treatment: Other: Manual therapy, exercises and education program; Other: Education program

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland
    • The rehabilitation clinic PROFEMED

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Body posture correction; Subjects from study group had an education about pelvic floor and additional a six week body posture therapy.	Other: Manual therapy, exercises and education program; a six week body posture therapy consisted of manual therapy (once per week) and home exercises; education about pelvic floor
OTHER: Without correction of body posture; Subjects form control group had only an education about pelvic floor.	Other: Education program; education about pelvic floor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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)	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	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	6 week (post-treatment)

Collaborators and Investigators

• Sponsor: Katarzyna Jórasz

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ACTUAL): April 1, 2019
• Study Completion (ACTUAL): March 31, 2020

Study Registration Dates

• First Submitted: April 18, 2020
• First Submitted That Met QC Criteria: April 24, 2020
• First Posted (ACTUAL): April 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 29, 2020
• Last Update Submitted That Met QC Criteria: April 24, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Urinary Incontinence, Stress
• Other Study ID Numbers: SKE 01-32/2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No