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Relations Between Pelvic Floor, Diaphragm and Trunk Muscles

NCT ID: NCT03858452

Last Updated: 2019-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-01

Study Completion Date

2012-12-30

Brief Summary

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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

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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.

Conditions

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Prostate Cancer Urinary Incontinence

Keywords

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Prostatectomy Rehabilitation Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Pelvic floor muscles training group

Pelvic floor muscles exercises twice a day for 30 min

Group Type ACTIVE_COMPARATOR

Muscles exercises program

Intervention Type PROCEDURE

Diaphragm muscles training group

Breathing exercises twice a day for 30 min

Group Type ACTIVE_COMPARATOR

Muscles exercises program

Intervention Type PROCEDURE

Abdominal muscles training group

Abdominal muscles exercises twice a day for 30 min

Group Type ACTIVE_COMPARATOR

Muscles exercises program

Intervention Type PROCEDURE

Interventions

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Muscles exercises program

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Lithuanian University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Zemyna Milasauskiene

Head of Research and Studies Coordination Centre

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daimantas Milonas, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

LUHS

References

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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.

Reference Type RESULT
PMID: 26421383 (View on PubMed)

Other Identifiers

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BE-2-61

Identifier Type: -

Identifier Source: org_study_id