Trial Information

Pelvic Floor Muscles Training in Urinary Disorders in Men With Prostate Cancer Undergoing Radiotherapy

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.