Pelvic Floor Muscles Training in Men Undergoing Radiotherapy for Prostate Cancer: Randomized Controlled Trial

NCT01762956 | Terminated

• 1 other identifier: 162/2015
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Prostate Cancer; Urologic Diseases

Keywords

Pelvic floor; Physical Therapy; Prostate cancer; Radiotherapy; Nuclear magnetic resonance

Outcome Measures

Primary Outcomes (1)

• Changes in the in the LUTS, anorectal and sexual complaints in six months.

  6 months after radiotherapy.

Study Arms (2)

Training group (TG)

EXPERIMENTAL

The group of patients undergoing radiotherapy and submitted to pelvic floor muscles training.

Other: Pelvic floor muscles training

Control group(CG)

NO INTERVENTION

The group of patients undergoing radiotherapy only.

Interventions

Pelvic floor muscles training OTHER

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.

Training group (TG)

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Clinical Hospital of Medical College of Ribeirão Preto (HCFMRP)

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

Related Publications (4)

• 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.

  PMID: 14595609 BACKGROUND

• 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.

  PMID: 20227168 BACKGROUND

• 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.

  PMID: 19635340 BACKGROUND

• 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.

  PMID: 21741700 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Urologic Diseases

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Aline M Ribeiro

  USP Ribeirão Preto

  PRINCIPAL INVESTIGATOR

• Harley F Oliveira, M.D.

  USP Ribeirão Preto

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: January 3, 2013
• First Posted: January 8, 2013
• Study Start: July 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 27, 2017

Record last verified: 2017-01

Locations

BR (1)