NCT03858452

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started Sep 2010

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2012

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 28, 2019

Completed
Last Updated

February 28, 2019

Status Verified

February 1, 2019

Enrollment Period

1.7 years

First QC Date

February 26, 2019

Last Update Submit

February 27, 2019

Conditions

Prostate CancerUrinary Incontinence

Keywords

ProstatectomyRehabilitationIncontinence

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Urinary loss dynamics

    6 month after radical prostatectomy

  • correlation between urinary incontinence and pelvic floor muscles strength and endurance dynamics

    6 months after radical prostatectomy

Study Arms (3)

Pelvic floor muscles training group

ACTIVE COMPARATOR

Pelvic floor muscles exercises twice a day for 30 min

Procedure: Muscles exercises program

Diaphragm muscles training group

ACTIVE COMPARATOR

Breathing exercises twice a day for 30 min

Procedure: Muscles exercises program

Abdominal muscles training group

ACTIVE COMPARATOR

Abdominal muscles exercises twice a day for 30 min

Procedure: Muscles exercises program

Interventions

Muscles exercises programPROCEDURE
Abdominal muscles training groupDiaphragm muscles training groupPelvic floor muscles training group

Eligibility Criteria

Age45 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • stable somatic state
  • written informed consent.

You may not qualify if:

  • chronic obstructive pulmonary disease,
  • surgical interventions in abdominal area,
  • complains in lower back,
  • acute musculoskeletal injuries in last 6 months
  • cognitive dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 26421383RESULT

MeSH Terms

Conditions

Prostatic NeoplasmsUrinary Incontinence

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Daimantas Milonas, MD, PhD

    LUHS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Research and Studies Coordination Centre

Study Record Dates

First Submitted

February 26, 2019

First Posted

February 28, 2019

Study Start

September 1, 2010

Primary Completion

May 30, 2012

Study Completion

December 30, 2012

Last Updated

February 28, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will share

De-identified individual participant data for all primary and secondary outcome measures will be made available

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will be available within 12 months of study completion
Access Criteria
Data access request will be reviewed by investigators. Requestors will be required to sign a Data Access Agreement