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Completed

NCT Number: NCT04366557

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.

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Key information

Conditions

Urinary Incontinence,Stress Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

25 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The rehabilitation clinic PROFEMED

Warsaw, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manual therapy, exercises and education program

Other

a six week body posture therapy consisted of manual therapy (once per week) and home exercises; education about pelvic floor

Education program

Other

education about pelvic floor

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Katarzyna Jórasz

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Apr 29, 2020
Registry last updated
Apr 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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