Pelvic Floor Muscles Training in Men Undergoing Radiotherapy for Prostate Cancer: Randomized Controlled Trial
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 through magnetic resonance imaging in patients undergoing radiotherapy for prostate cancer. Secondary objectives are limited in to evaluate the quality of life index of the sample measured using WHO Quality of Life-BREF (WHOQOL-BREF) and investigate the effect of irradiation of the prostate on the strength and myoelectric activity of the pelvic floor muscles evaluated by perineometry and electromyography respectively. 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Pelvic Floor Muscles Training in Men Undergoing Radiotherapy for Prostate Cancer: Randomized Controlled Trial|
- Changes in the value of pelvic floor muscle strength in six months [ Time Frame: 6 months after radiotherapy. ] [ Designated as safety issue: No ]
|Study Start Date:||June 2015|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Experimental: Training group (TG)
The group of patients undergoing radiotherapy and submitted to pelvic floor muscles training.
Other: Pelvic floor muscles training
The supervised muscle training will be conducted twice a week with 45 minutes each session during 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 accompanied by an audio CD with explanations of each exercise to be performed. The patient will be encouraged to perform the exercises while listening to the audio compact disk (CD) for better adherence to the program. 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.
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 around 60 years with confirmed diagnosis of prostate cancer by biopsy and having clinical indication for radiotherapy 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 06 months started of radiotherapy; (3) Assessment 03: 06 months after the assessment 02; (4) Assessment 04: 06 months after the assessment 03. 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 (WHOQOL-BREF) which consists of 26 questions, where two questions are general issues of quality of life and the other representing the 24 facets that make up the original instrument, the WHOQOL-100: physical domain, the psychological domain and social relationships, environment.
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 twice a week with 45 minutes each session during 12 weeks (3 months), 24 sessions in total. 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 accompanied by an audio CD with explanations of each exercise to be performed. The patient will be encouraged to perform the exercises while listening to the audio CD for better adherence to the program. 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01762956
|Contact: Aline M Ribeirofirstname.lastname@example.org|
|Clinical Hospital of Medical College of Ribeirão Preto (HCFMRP)||Recruiting|
|Ribeirão Preto, São Paulo, Brazil, 14048-900|
|Contact: Aline M Ribeiro +551681105875 email@example.com|
|Principal Investigator: Aline M Ribeiro|
|Principal Investigator:||Aline M Ribeiro||USP Ribeirão Preto|
|Study Director:||Harley F Oliveira, M.D.||USP Ribeirão Preto|