Prostate CancerNCT03858452
Relations Between Pelvic Floor, Diaphragm and Trunk Muscles
A study testing Muscles exercises program in people with Prostate Cancer and Urinary Incontinence, run by Lithuanian University of Health Sciences.
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. Read more about this study
- Who is it for?
- Ages 45 to 75 years, men only
- Conditions the study is for
- Prostate Cancer, Urinary Incontinence
- What is being tested?
- Muscles exercises program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2010to 30 Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stable somatic state
- written informed consent.
Who cannot join
- chronic obstructive pulmonary disease,
- surgical interventions in abdominal area,
- complains in lower back,
- acute musculoskeletal injuries in last 6 months
- cognitive dysfunction
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer, Urinary Incontinence
- Being tested
- Muscles exercises program
- Keywords
- Prostatectomy, Rehabilitation, Incontinence
- Medical subject headings
- Prostatic Neoplasms, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscles exercises programProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Pelvic floor muscles training group | Active comparator | Pelvic floor muscles exercises twice a day for 30 min Receives: Procedure: Muscles exercises program |
| Diaphragm muscles training group | Active comparator | Breathing exercises twice a day for 30 min Receives: Procedure: Muscles exercises program |
| Abdominal muscles training group | Active comparator | Abdominal muscles exercises twice a day for 30 min Receives: Procedure: Muscles exercises program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of activation of different muscles groups on pelvic floor muscles strength
Pelvic floor muscles strength was measured in cmH2O
Measured: 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.
Measured: 6 months after radical prostatectomy.
Secondary outcomes (2)
Urinary loss dynamics
Pad weight by grams during 8 hours pad test
Measured: 6 month after radical prostatectomy
correlation between urinary incontinence and pelvic floor muscles strength and endurance dynamics
correlation coefficient
Measured: 6 months after radical prostatectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start1 Sep 2010
- Primary completion30 May 2012
- Study completion30 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zemyna Milasauskiene, Lithuanian University of Health Sciences
- Investigators
- Daimantas Milonas, MD, PhD, Principal investigator, LUHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858452
- Sponsor's protocol ID
- BE-2-61
- Status last verified
- Feb 2019
- First submitted
- 26 Feb 2019
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available
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.
PubMed 26421383
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Functional Relations and Their Changes Between Pelvic Floor, Diaphragm and Trunk Muscles in Men After Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT03858452
- Acronym / sponsor ID
- BE-2-61
- Conditions
- Prostate Cancer, Urinary Incontinence
- Keywords
- Prostatectomy, Rehabilitation, Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 1 Sep 2010 (actual)
- Primary completion
- 30 May 2012 (actual)
- Study completion
- 30 Dec 2012 (actual)
- First posted
- 28 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pelvic floor muscles training group | Active comparator | Procedure: Muscles exercises programPelvic floor muscles exercises twice a day for 30 min |
| Diaphragm muscles training group | Active comparator | Procedure: Muscles exercises programBreathing exercises twice a day for 30 min |
| Abdominal muscles training group | Active comparator | Procedure: Muscles exercises programAbdominal muscles exercises twice a day for 30 min |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- stable somatic state
- written informed consent.
Key exclusion criteria (5 listed)
- chronic obstructive pulmonary disease,
- surgical interventions in abdominal area,
- complains in lower back,
- acute musculoskeletal injuries in last 6 months
- cognitive dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscles exercises program | Procedure or surgery | Abdominal muscles training group, Diaphragm muscles training group, Pelvic floor muscles training group |
Primary outcome
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
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.
2 secondary outcomes
Urinary loss dynamics
Time frame: 6 month after radical prostatectomy
correlation between urinary incontinence and pelvic floor muscles strength and endurance dynamics
Time frame: 6 months after radical prostatectomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- Results publication: PubMed 26421383Zachovajeviene 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daimantas Milonas, MD, PhD principal investigator
LUHS
Questions about this trial
What is this clinical trial studying?
A study testing Muscles exercises program in people with Prostate Cancer and Urinary Incontinence, run by Lithuanian University of Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of activation of different muscles groups on pelvic floor muscles strength (time frame: 6 months after radical prostatectomy.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03858452, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2019.