- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01762956
Pelvic Floor Muscles Training in Men Undergoing Radiotherapy for Prostate Cancer: Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
São Paulo
-
Ribeirão Preto, São Paulo, Brazil, 14048-900
- Clinical Hospital of Medical College of Ribeirão Preto (HCFMRP)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Training group (TG)
The group of patients undergoing radiotherapy and submitted to pelvic floor muscles training.
|
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.
|
No Intervention: Control group(CG)
The group of patients undergoing radiotherapy only.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in the in the LUTS, anorectal and sexual complaints in six months.
Time Frame: 6 months after radiotherapy.
|
6 months after radiotherapy.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Aline M Ribeiro, USP Ribeirão Preto
- Study Director: Harley F Oliveira, M.D., USP Ribeirão Preto
Publications and helpful links
General Publications
- Centemero 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.
- 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.
- Dorey 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.
- Glazener 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. Erratum In: Lancet. 2012 Feb 4;379(9814):412.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 162/2015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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