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Relations Between Pelvic Floor, Diaphragm and Trunk Muscles

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03858452
Recruitment Status : Completed
First Posted : February 28, 2019
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Zemyna Milasauskiene, Lithuanian University of Health Sciences

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Urinary Incontinence Procedure: Muscles exercises program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Functional Relations and Their Changes Between Pelvic Floor, Diaphragm and Trunk Muscles in Men After Radical Prostatectomy
Actual Study Start Date : September 1, 2010
Actual Primary Completion Date : May 30, 2012
Actual Study Completion Date : December 30, 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Pelvic floor muscles training group
Pelvic floor muscles exercises twice a day for 30 min
Procedure: Muscles exercises program
Active Comparator: Diaphragm muscles training group
Breathing exercises twice a day for 30 min
Procedure: Muscles exercises program
Active Comparator: Abdominal muscles training group
Abdominal muscles exercises twice a day for 30 min
Procedure: Muscles exercises program



Primary Outcome Measures :
  1. Effect of activation of different muscles groups on pelvic floor muscles strength [ Time Frame: 6 months after radical prostatectomy. ]
    Pelvic floor muscles strength was measured in cmH2O

  2. Effect of activation of different muscles groups on pelvic floor muscles endurance. [ Time Frame: 6 months after radical prostatectomy. ]
    Pelvic floor muscles endurance was measured in seconds.


Secondary Outcome Measures :
  1. Urinary loss dynamics [ Time Frame: 6 month after radical prostatectomy ]
    Pad weight by grams during 8 hours pad test

  2. correlation between urinary incontinence and pelvic floor muscles strength and endurance dynamics [ Time Frame: 6 months after radical prostatectomy ]
    correlation coefficient



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858452


Sponsors and Collaborators
Lithuanian University of Health Sciences
Investigators
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Principal Investigator: Daimantas Milonas, MD, PhD LUHS
Publications of Results:
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Responsible Party: Zemyna Milasauskiene, Head of Research and Studies Coordination Centre, Lithuanian University of Health Sciences
ClinicalTrials.gov Identifier: NCT03858452    
Other Study ID Numbers: BE-2-61
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available within 12 months of study completion
Access Criteria: Data access request will be reviewed by investigators. Requestors will be required to sign a Data Access Agreement

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zemyna Milasauskiene, Lithuanian University of Health Sciences:
Prostatectomy
Rehabilitation
Incontinence
Additional relevant MeSH terms:
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Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations