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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by University of Sao Paulo
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Aline Moreira Ribeiro, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01762956
First received: January 3, 2013
Last updated: January 12, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Prostate Cancer
Urologic Diseases
Other: Pelvic floor muscles training

Study Type: Interventional
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 Urinary Disorders in Men With Prostate Cancer Undergoing Radiotherapy

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Changes in the value of pelvic floor muscle strength in six months [ Time Frame: 6 months after radiotherapy. ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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 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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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;
  • 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;
  • 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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01762956

Contacts
Contact: Aline M Ribeiro +551681105875 amribeiro@usp.br

Locations
Brazil
Clinical Hospital of Medical College of Ribeirão Preto (HCFMRP) Not yet recruiting
Ribeirão Preto, São Paulo, Brazil, 14048-900
Contact: Aline M Ribeiro    +551681105875    amribeiro@usp.br   
Principal Investigator: Aline M Ribeiro         
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Aline M Ribeiro USP Ribeirão Preto
Study Director: Harley F Oliveira, M.D. USP Ribeirão Preto
  More Information

Publications:
Responsible Party: Aline Moreira Ribeiro, Physiotherapist, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01762956     History of Changes
Other Study ID Numbers: 11179/2011
Study First Received: January 3, 2013
Last Updated: January 12, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
Pelvic floor
Physical Therapy
Prostate cancer
Radiotherapy
Nuclear magnetic resonance

Additional relevant MeSH terms:
Prostatic Neoplasms
Urologic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014