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

NCT04366557 | Completed

• 1 other identifier: SKE 01-32/2018
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence,Stress

Outcome Measures

Primary Outcomes (6)

• 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)

Study Arms (2)

Body posture correction

EXPERIMENTAL

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

Without correction of body posture

OTHER

Subjects form control group had only an education about pelvic floor.

Other: Education program

Interventions

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

Body posture correction

Education program OTHER

education about pelvic floor

Without correction of body posture

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• stress urinary incontinence (confirmed by a medical examination)
• female
• age between 25 and 45 years old

You may not qualify if:

• gynecological, spinal, and abdominal surgery (excluding cesarean delivery)
• menopause
• spinal and pelvis injuries
• chronic diseases of the circulatory and respiratory system
• neurlogical accidance

Sponsors & Collaborators

• Katarzyna Jórasz: lead

Study Sites (1)

The rehabilitation clinic PROFEMED

Warsaw, Poland

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Musculoskeletal Manipulations; Exercise; Early Intervention, Educational

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects covered by the assigned number
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants divided into two groups (the study and the control)

Study Record Dates

• First Submitted: April 18, 2020
• First Posted: April 29, 2020
• Study Start: January 1, 2019
• Primary Completion: April 1, 2019
• Study Completion: March 31, 2020
• Last Updated: April 29, 2020

Record last verified: 2020-04

Locations

PL (1)