Relations Between Pelvic Floor, Diaphragm and Trunk Muscles
Primary Purpose
Prostate Cancer, Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Muscles exercises program
Sponsored by

About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostatectomy, Rehabilitation, Incontinence
Eligibility Criteria
Inclusion Criteria:
- stable somatic state
- written informed consent.
Exclusion Criteria:
- chronic obstructive pulmonary disease,
- surgical interventions in abdominal area,
- complains in lower back,
- acute musculoskeletal injuries in last 6 months
- cognitive dysfunction
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Pelvic floor muscles training group
Diaphragm muscles training group
Abdominal muscles training group
Arm Description
Pelvic floor muscles exercises twice a day for 30 min
Breathing exercises twice a day for 30 min
Abdominal muscles exercises twice a day for 30 min
Outcomes
Primary Outcome Measures
Effect of activation of different muscles groups on pelvic floor muscles strength
Pelvic floor muscles strength was measured in cmH2O
Effect of activation of different muscles groups on pelvic floor muscles endurance.
Pelvic floor muscles endurance was measured in seconds.
Secondary Outcome Measures
Urinary loss dynamics
Pad weight by grams during 8 hours pad test
correlation between urinary incontinence and pelvic floor muscles strength and endurance dynamics
correlation coefficient
Full Information
NCT ID
NCT03858452
First Posted
February 26, 2019
Last Updated
February 27, 2019
Sponsor
Lithuanian University of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03858452
Brief Title
Relations Between Pelvic Floor, Diaphragm and Trunk Muscles
Official Title
Evaluation of Functional Relations and Their Changes Between Pelvic Floor, Diaphragm and Trunk Muscles in Men After Radical Prostatectomy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2010 (Actual)
Primary Completion Date
May 30, 2012 (Actual)
Study Completion Date
December 30, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lithuanian University of Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The present study evaluates the functional relations of pelvic floor, diaphragm, and torso muscles, their variation and correlations with urinary incontinence while separately training physical characteristics of the mentioned muscles in men after radical prostatectomy.
Detailed Description
During the last two decades, the connection between pelvic floor muscles (PFM) and abdominal muscles or diaphragm has been detected: PFM contract and relax during the inhalation and exhalation in pace with the diaphragm; the activity of the PFM increases with the increase of intra-abdominal pressure during forced exhalations or cough. The role of pelvic floor is essential for the synergy of diaphragm and abdominal muscles in maintenance of intra-abdominal pressure. According to the aforementioned physiological functional relationships, the investigators have postulated a hypothesis that diaphragm muscles training and abdominal muscles training could have similar effect as direct PFM training on pelvic floor muscles strength and pelvic floor muscles endurance measured using perineometer in men after radical prostatectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Urinary Incontinence
Keywords
Prostatectomy, Rehabilitation, Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
148 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pelvic floor muscles training group
Arm Type
Active Comparator
Arm Description
Pelvic floor muscles exercises twice a day for 30 min
Arm Title
Diaphragm muscles training group
Arm Type
Active Comparator
Arm Description
Breathing exercises twice a day for 30 min
Arm Title
Abdominal muscles training group
Arm Type
Active Comparator
Arm Description
Abdominal muscles exercises twice a day for 30 min
Intervention Type
Procedure
Intervention Name(s)
Muscles exercises program
Primary Outcome Measure Information:
Title
Effect of activation of different muscles groups on pelvic floor muscles strength
Description
Pelvic floor muscles strength was measured in cmH2O
Time Frame
6 months after radical prostatectomy.
Title
Effect of activation of different muscles groups on pelvic floor muscles endurance.
Description
Pelvic floor muscles endurance was measured in seconds.
Time Frame
6 months after radical prostatectomy.
Secondary Outcome Measure Information:
Title
Urinary loss dynamics
Description
Pad weight by grams during 8 hours pad test
Time Frame
6 month after radical prostatectomy
Title
correlation between urinary incontinence and pelvic floor muscles strength and endurance dynamics
Description
correlation coefficient
Time Frame
6 months after radical prostatectomy
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
stable somatic state
written informed consent.
Exclusion Criteria:
chronic obstructive pulmonary disease,
surgical interventions in abdominal area,
complains in lower back,
acute musculoskeletal injuries in last 6 months
cognitive dysfunction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daimantas Milonas, MD, PhD
Organizational Affiliation
LUHS
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data for all primary and secondary outcome measures will be made available
IPD Sharing Time Frame
Data will be available within 12 months of study completion
IPD Sharing Access Criteria
Data access request will be reviewed by investigators. Requestors will be required to sign a Data Access Agreement
Citations:
PubMed Identifier
26421383
Citation
Zachovajeviene B, Siupsinskas L, Zachovajevas P, Milonas D. Dynamics of pelvic floor muscle functional parameters and their correlations with urinary incontinence in men after radical prostatectomy. Neurourol Urodyn. 2017 Jan;36(1):126-131. doi: 10.1002/nau.22887. Epub 2015 Sep 30.
Results Reference
result
Learn more about this trial
Relations Between Pelvic Floor, Diaphragm and Trunk Muscles
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