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Completed

NCT Number: NCT03858452

Relations Between Pelvic Floor, Diaphragm and Trunk Muscles

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.

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Key information

Conditions

Prostate Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urological Manifestations

Age range

45 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Muscles exercises program

Procedure

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Lithuanian University of Health Sciences

Other

Registry information

Official study title

Evaluation of Functional Relations and Their Changes Between Pelvic Floor, Diaphragm and Trunk Muscles in Men After Radical Prostatectomy

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 28, 2019
Registry last updated
Feb 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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