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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
Lithuanian University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostatectomy, Rehabilitation, Incontinence

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

    First Posted
    February 26, 2019
    Last Updated
    February 27, 2019
    Sponsor
    Lithuanian University of Health Sciences
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    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

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    Relations Between Pelvic Floor, Diaphragm and Trunk Muscles

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