Prostate CancerNCT01762956
Pelvic Floor Muscles Training in Men Undergoing Radiotherapy for Prostate Cancer: Randomized Controlled Trial
A study testing Pelvic floor muscles training in people with Prostate Cancer and Urologic Diseases, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The pelvic floor disorders are a major problem in our current society with manifestations of micturition disorders, defecatory problems and sexual dysfunction. The pelvic floor muscles training arouses interest due the few studies on this subject. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Prostate Cancer, Urologic Diseases
- What is being tested?
- Pelvic floor muscles training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2015to Dec 2016
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men aged equal or higher than 45 years-old with confirmed diagnosis of prostate cancer by biopsy and having clinical indication for radiotherapy who follow-up in the HCFMRP-USP;
- No age distinction of race, creed and education;
- Men with graduation of PFM function greater than or equal to grade 2 evaluated by anal digital palpation (Oxford Scale Modified);
- Men who voluntarily consent to participate in research.
Who cannot join
- Men with anatomical abnormalities in perineal region due sequelae of surgery, pathology, trauma or injury sites;
- Men with associated neurological pathologies;
- Indication for adjuvant or rescue RT (radical prostatectomy);
- Men with acquired immune deficiency syndrome;
- PFMT carried out previously;
- Men with cardiac pacemakers, aneurysm clips, neurostimulators or other factors that preclude the application of review procedures established in this study;
- Men who have not completed proposed radiotherapy treatment;
- Men who do not accept to participate in this study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Clinical Hospital of Medical College of Ribeirão Preto (HCFMRP)
Ribeirão Preto, São Paulo, 14048-900
About this study
The pelvic floor disorders are a major problem in our current society with manifestations of micturition disorders, defecatory problems and sexual dysfunction. The pelvic floor muscles training arouses interest due the few studies on this subject. Studies are being conducted with emphasis on the post-prostatectomy urinary disorders, however, not associated with radiotherapy. The study of the effect of radiotherapy in these muscles is still uncertain. At right, we do not know if the effect of radiation can trigger important anatomical changes that could lead to pelvic floor disorders manifesting clinically as defecatory and urinary disorders. These issues motivate us to research, focusing on the evaluation of these muscles through magnetic nuclear resonance considering that radiation therapy has been increasingly used as a therapeutic option in the treatment of prostate cancer. The primary objective of this is to verify the effect of pelvic floor muscles training (PFMT) tract symptoms (LUTS), anorectal and sexual complaints in men with prostate cancer (PCa) treated with radiotherapy (RT). Secondly, the objective is to evaluate the effect of PFMT in its function and in the severity of urinary incontinence (UI) and evaluate the quality of life. The assessment of the changes occurred by the effect of radiation separately and jointly to the training of the pelvic floor muscles can help us to better understand some of the dysfunctions presented in this sample of patients as well as understanding the effect and the possible contribution of training of these muscles for treatment and/or prevention of these disorders.
Read the detailed description
This present research is a randomized controlled clinical trial to be held in Clinics Hospital of Medical School of Ribeirão Preto - University of São Paulo (HCFMRP-USP) including men with confirmed diagnosis of prostate cancer by biopsy and having clinical indication for radiotherapy treatment (RT) who follow-up in the HCFMRP-USP and voluntarily consent to participate in this research. After consent, each patient must sign the consent term and then will be allocated by randomization in one of the following study groups:
- Training group (TG): the group of patients undergoing radiotherapy and submitted to pelvic floor muscles training;
- Control group (CG): the group of patients undergoing radiotherapy only. This research consists in four assessment: (1) Assessment 01: before started of radiotherapy; (2) Assessment 02: after two weeks started of RT; (3) Assessment 03: 03 months after started of RT (4) Assessment 04: 06 months after started of RT. All these assessments will be common for the participants of the research independently from the group they belong.
In each assessment, images of the pelvic floor muscles will be acquired by nuclear magnetic resonance. Parallel to the MRI, there will be a clinical assessment of the patient which consist of anamnesis and physical examination, where the assessment of pelvic floor muscle function will be tested objectively using a perineometer to evaluate the peak and the mean contraction as well as the duration of the performed sustained contraction. Data will be collected from three contractions, whose mean value will be used for this study. The myoelectric activity will be evaluated using electromyography biofeedback with electromyography anal probes. The patient will also answer a quality of life questionnaire (EORTC QLQ-C30 e PR25) and the others questionnaire: ICIQ-SF, QS-M and Jorge-Wexner Scale.
The patient of TG will be included in a supervised training protocol of the pelvic floor muscles. This protocol will be conducted in conjunction with the radiotherapy sessions.
The supervised muscle training will be conducted once a week with 45 minutes each session during the RT (12 weeks - 3 months). In addition to the supervised sessions, patients in this group will be instructed about the practice of home exercises and receive a guidance booklet of exercises with explanations of each exercise to be performed. These exercises must be performed daily and should be written down in the worksheet when they are performed. After this 3 month period, the patients will be encouraged to continue the exercise protocol at home without supervision. They must attend monthly to monitor adherence to home exercises.
The control group (CG) patients will not be instructed to perform pelvic floor exercises, instead they will only be assessed within the stipulated time.
- Conditions
- Prostate Cancer, Urologic Diseases
- Being tested
- Pelvic floor muscles training
- Keywords
- Pelvic floor, Physical Therapy, Prostate cancer, Radiotherapy, Nuclear magnetic resonance
- Medical subject headings
- Prostatic Neoplasms, Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor muscles trainingOther
The supervised muscle training will be conducted once a week with 45 minutes each session during the RT (12 weeks). In addition to the supervised sessions, patients will be instructed about the practice of home exercises and receive a guidance booklet of exercises with explanations of each exercise to be performed. These exercises must be performed daily and should be written down in the worksheet when they are performed. After this 3 month period, the patients will be encouraged to continue the exercise protocol at home without supervision. They must attend monthly to monitor adherence to home exercises.
| Study group | Role | What they receive |
|---|---|---|
| Training group (TG) | Experimental | The group of patients undergoing radiotherapy and submitted to pelvic floor muscles training. Receives: Other: Pelvic floor muscles training |
| Control group(CG) | No intervention | The group of patients undergoing radiotherapy only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the in the LUTS, anorectal and sexual complaints in six months.
Measured: 6 months after radiotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2013 (estimated)
- Study startJul 2015
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: Unobtainable sample size
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Aline Moreira Ribeiro, University of Sao Paulo
- Investigators
- Aline M Ribeiro, Principal investigator, USP Ribeirão PretoHarley F Oliveira, M.D., Study director, USP Ribeirão Preto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01762956
- Sponsor's protocol ID
- 162/2015
- Status last verified
- Jan 2017
- First submitted
- 3 Jan 2013
- Last updated
- 27 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Bo K. Pelvic floor muscle strength and response to pelvic floor muscle training for stress urinary incontinence. Neurourol Urodyn. 2003;22(7):654-8. doi: 10.1002/nau.10153.
PubMed 14595609Centemero A, Rigatti L, Giraudo D, Lazzeri M, Lughezzani G, Zugna D, Montorsi F, Rigatti P, Guazzoni G. Preoperative pelvic floor muscle exercise for early continence after radical prostatectomy: a randomised controlled study. Eur Urol. 2010 Jun;57(6):1039-43. doi: 10.1016/j.eururo.2010.02.028. Epub 2010 Mar 1.
PubMed 20227168Dorey G, Glazener C, Buckley B, Cochran C, Moore K. Developing a pelvic floor muscle training regimen for use in a trial intervention. Physiotherapy. 2009 Sep;95(3):199-209. doi: 10.1016/j.physio.2009.03.003. Epub 2009 Jul 8.
PubMed 19635340Glazener C, Boachie C, Buckley B, Cochran C, Dorey G, Grant A, Hagen S, Kilonzo M, McDonald A, McPherson G, Moore K, Norrie J, Ramsay C, Vale L, N'Dow J. Urinary incontinence in men after formal one-to-one pelvic-floor muscle training following radical prostatectomy or transurethral resection of the prostate (MAPS): two parallel randomised controlled trials. Lancet. 2011 Jul 23;378(9788):328-37. doi: 10.1016/S0140-6736(11)60751-4. Epub 2011 Jul 7.
PubMed 21741700
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Floor Muscles Training in Men Undergoing Radiotherapy for Prostate Cancer: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01762956
- Acronym / sponsor ID
- 162/2015
- Conditions
- Prostate Cancer, Urologic Diseases
- Keywords
- Pelvic floor, Physical Therapy, Prostate cancer, Radiotherapy, Nuclear magnetic resonance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unobtainable sample size
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jul 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 8 Jan 2013 (estimated)
- 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 pelvic floor disorders are a major problem in our current society with manifestations of micturition disorders, defecatory problems and sexual dysfunction. The pelvic floor muscles training arouses interest due the few studies on this subject. Studies are being conducted with emphasis on the post-prostatectomy urinary disorders, however, not associated with radiotherapy. The study of the effect of radiotherapy in these muscles is still uncertain. At right, we do not know if the effect of radiation can trigger important anatomical changes that could lead to pelvic floor disorders manifesting clinically as defecatory and urinary disorders. These issues motivate us to research, focusing on the evaluation of these muscles through magnetic nuclear resonance considering that radiation therapy has been increasingly used as a therapeutic option in the treatment of prostate cancer. The primary objective of this is to verify the effect of pelvic floor muscles training (PFMT) tract symptoms (LUTS), anorectal and sexual complaints in men with prostate cancer (PCa) treated with radiotherapy (RT). Secondly, the objective is to evaluate the effect of PFMT in its function and in the severity of urinary incontinence (UI) and evaluate the quality of life. The assessment of the changes occurred by the effect of radiation separately and jointly to the training of the pelvic floor muscles can help us to better understand some of the dysfunctions presented in this sample of patients as well as understanding the effect and the possible contribution of training of these muscles for treatment and/or prevention of these disorders.
Detailed description
This present research is a randomized controlled clinical trial to be held in Clinics Hospital of Medical School of Ribeirão Preto - University of São Paulo (HCFMRP-USP) including men with confirmed diagnosis of prostate cancer by biopsy and having clinical indication for radiotherapy treatment (RT) who follow-up in the HCFMRP-USP and voluntarily consent to participate in this research. After consent, each patient must sign the consent term and then will be allocated by randomization in one of the following study groups:
- Training group (TG): the group of patients undergoing radiotherapy and submitted to pelvic floor muscles training;
- Control group (CG): the group of patients undergoing radiotherapy only. This research consists in four assessment: (1) Assessment 01: before started of radiotherapy; (2) Assessment 02: after two weeks started of RT; (3) Assessment 03: 03 months after started of RT (4) Assessment 04: 06 months after started of RT. All these assessments will be common for the participants of the research independently from the group they belong.
In each assessment, images of the pelvic floor muscles will be acquired by nuclear magnetic resonance. Parallel to the MRI, there will be a clinical assessment of the patient which consist of anamnesis and physical examination, where the assessment of pelvic floor muscle function will be tested objectively using a perineometer to evaluate the peak and the mean contraction as well as the duration of the performed sustained contraction. Data will be collected from three contractions, whose mean value will be used for this study. The myoelectric activity will be evaluated using electromyography biofeedback with electromyography anal probes. The patient will also answer a quality of life questionnaire (EORTC QLQ-C30 e PR25) and the others questionnaire: ICIQ-SF, QS-M and Jorge-Wexner Scale.
The patient of TG will be included in a supervised training protocol of the pelvic floor muscles. This protocol will be conducted in conjunction with the radiotherapy sessions.
The supervised muscle training will be conducted once a week with 45 minutes each session during the RT (12 weeks - 3 months). In addition to the supervised sessions, patients in this group will be instructed about the practice of home exercises and receive a guidance booklet of exercises with explanations of each exercise to be performed. These exercises must be performed daily and should be written down in the worksheet when they are performed. After this 3 month period, the patients will be encouraged to continue the exercise protocol at home without supervision. They must attend monthly to monitor adherence to home exercises.
The control group (CG) patients will not be instructed to perform pelvic floor exercises, instead they will only be assessed within the stipulated time.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training group (TG) | Experimental | Other: Pelvic floor muscles trainingThe group of patients undergoing radiotherapy and submitted to pelvic floor muscles training. |
| Control group(CG) | No intervention | –The group of patients undergoing radiotherapy only. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men aged equal or higher than 45 years-old with confirmed diagnosis of prostate cancer by biopsy and having clinical indication for radiotherapy who follow-up in the HCFMRP-USP;
- No age distinction of race, creed and education;
- Men with graduation of PFM function greater than or equal to grade 2 evaluated by anal digital palpation (Oxford Scale Modified);
- Men who voluntarily consent to participate in research.
Key exclusion criteria (8 listed)
- Men with anatomical abnormalities in perineal region due sequelae of surgery, pathology, trauma or injury sites;
- Men with associated neurological pathologies;
- Indication for adjuvant or rescue RT (radical prostatectomy);
- Men with acquired immune deficiency syndrome;
- PFMT carried out previously;
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 |
|---|---|---|
| Pelvic floor muscles trainingThe supervised muscle training will be conducted once a week with 45 minutes each session during the RT (12 weeks). In addition to the supervised sessions, patients will be instructed about the practice of home exercises and receive a guidance booklet of exercises with explanations of each exercise to be performed. These exercises must be performed daily and should be written down in the worksheet when they are performed. After this 3 month period, the patients will be encouraged to continue the exercise protocol at home without supervision. They must attend monthly to monitor adherence to home exercises. | Other | Training group (TG) |
Primary outcome
Changes in the in the LUTS, anorectal and sexual complaints in six months.
Time frame: 6 months after radiotherapy.
Results and safety
The study was stopped early (reason given: Unobtainable sample size). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2017.
- Background: PubMed 14595609Bo K. Pelvic floor muscle strength and response to pelvic floor muscle training for stress urinary incontinence. Neurourol Urodyn. 2003;22(7):654-8. doi: 10.1002/nau.10153.
- Background: PubMed 20227168Centemero A, Rigatti L, Giraudo D, Lazzeri M, Lughezzani G, Zugna D, Montorsi F, Rigatti P, Guazzoni G. Preoperative pelvic floor muscle exercise for early continence after radical prostatectomy: a randomised controlled study. Eur Urol. 2010 Jun;57(6):1039-43. doi: 10.1016/j.eururo.2010.02.028. Epub 2010 Mar 1.
- Background: PubMed 19635340Dorey G, Glazener C, Buckley B, Cochran C, Moore K. Developing a pelvic floor muscle training regimen for use in a trial intervention. Physiotherapy. 2009 Sep;95(3):199-209. doi: 10.1016/j.physio.2009.03.003. Epub 2009 Jul 8.
- Background: PubMed 21741700Glazener C, Boachie C, Buckley B, Cochran C, Dorey G, Grant A, Hagen S, Kilonzo M, McDonald A, McPherson G, Moore K, Norrie J, Ramsay C, Vale L, N'Dow J. Urinary incontinence in men after formal one-to-one pelvic-floor muscle training following radical prostatectomy or transurethral resection of the prostate (MAPS): two parallel randomised controlled trials. Lancet. 2011 Jul 23;378(9788):328-37. doi: 10.1016/S0140-6736(11)60751-4. Epub 2011 Jul 7.
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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.
Aline M Ribeiro principal investigator
USP Ribeirão Preto
Harley F Oliveira, M.D. study director
USP Ribeirão Preto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor muscles training in people with Prostate Cancer and Urologic Diseases, run by University of Sao Paulo at 1 site in Brazil.
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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 27 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early (reason given: Unobtainable sample size). Results are not available in the source record.
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?
Changes in the in the LUTS, anorectal and sexual complaints in six months. (time frame: 6 months after radiotherapy.). 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 NCT01762956, which also lists 4 linked publications.
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 27 Jan 2017.