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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03858452
Other study ID # BE-2-61
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2010
Est. completion date December 30, 2012

Study information

Verified date February 2019
Source Lithuanian University of Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 148
Est. completion date December 30, 2012
Est. primary completion date May 30, 2012
Accepts healthy volunteers No
Gender Male
Age group 45 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Muscles exercises program


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Lithuanian University of Health Sciences

References & Publications (1)

Zachovajeviene B, Šiupšinskas 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/n — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Effect of activation of different muscles groups on pelvic floor muscles strength Pelvic floor muscles strength was measured in cmH2O 6 months after radical prostatectomy.
Primary Effect of activation of different muscles groups on pelvic floor muscles endurance. Pelvic floor muscles endurance was measured in seconds. 6 months after radical prostatectomy.
Secondary Urinary loss dynamics Pad weight by grams during 8 hours pad test 6 month after radical prostatectomy
Secondary correlation between urinary incontinence and pelvic floor muscles strength and endurance dynamics correlation coefficient 6 months after radical prostatectomy
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