Relations Between Pelvic Floor, Diaphragm and Trunk Muscles

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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence; Prostate Cancer
• Intervention / Treatment: Procedure: Muscles exercises program

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.

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary loss dynamics	Pad weight by grams during 8 hours pad test	6 month after radical prostatectomy
correlation between urinary incontinence and pelvic floor muscles strength and endurance dynamics	correlation coefficient	6 months after radical prostatectomy

Collaborators and Investigators

• Sponsor: Lithuanian University of Health Sciences
• Investigators: Principal Investigator: Daimantas Milonas, MD, PhD, LUHS

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2010
• Primary Completion (Actual): May 30, 2012
• Study Completion (Actual): December 30, 2012

Study Registration Dates

• First Submitted: February 26, 2019
• First Submitted That Met QC Criteria: February 27, 2019
• First Posted (Actual): February 28, 2019

Study Record Updates

• Last Update Posted (Actual): February 28, 2019
• Last Update Submitted That Met QC Criteria: February 27, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Rehabilitation; Incontinence; Prostatectomy
• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence
• Other Study ID Numbers: BE-2-61

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No