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

Urinary Incontinence,Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04366557
• Other study ID #: SKE 01-32/2018
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: April 2020
• Source: Józef Pilsudski University of Physical Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 31, 2020
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Incontinence,Stress

Intervention

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
• Education program
education about pelvic floor

Locations

Country	Name	City	State
Poland	The rehabilitation clinic PROFEMED	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Katarzyna Jórasz

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)