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

• Sponsor: Katarzyna Jórasz (Other)
• Overall Status: Completed
• CT.gov ID: NCT04366557
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.9
• Patients Per Site Per Month: 4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence,Stress	Other: Manual therapy, exercises and education program; Other: Education program	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participants divided into two groups (the study and the control)Participants divided into two groups (the study and the control)
• Masking: Single (Participant)
• Masking Description: Subjects covered by the assigned number
• Primary Purpose: Treatment
• Official Title: The Influence of the Body Posture Correcting Therapy on Pelvic Floor Muscles Function
• Actual Study Start Date: Jan 1, 2019
• Actual Primary Completion Date: Apr 1, 2019
• Actual Study Completion Date: Mar 31, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF) [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) [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) [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 [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 [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The rehabilitation clinic PROFEMED	Warsaw		Poland

Sponsors and Collaborators

• Katarzyna Jórasz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Katarzyna Jórasz, Principal Investigator, Józef Piłsudski University of Physical Education
• ClinicalTrials.gov Identifier: NCT04366557
• Other Study ID Numbers: SKE 01-32/2018
• First Posted: Apr 29, 2020
• Last Update Posted: Apr 29, 2020
• Last Verified: Apr 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Urinary Incontinence; Urinary Incontinence, Stress

Study Results

No Results Posted as of Apr 29, 2020