Pelvic Floor Muscles Training After Radical Prostatectomy.

Summary

Prostate cancer (PCa) is a malignant tumor commonly diagnosed among men in the USA and Europe. About 81% of cases of prostate cancer are detected early on, which allows patients to receive effective treatment. High risk cancer patients may undergo radical prostatectomy (RP) which includes the removal of the entire prostate gland together with both seminal vesicles, prostatic urethra, and bilateral pelvic lymph nodes. Even though RP has been improved over decades, patients are still at risk of surgical and post-surgical complications. The most common complications include urinary incontinence and erectile dysfunction. Pelvic floor muscle training is recognized as the physiotherapeutic modality for the treatment of urinary incontinence in men after radical prostatectomy. This method is recommended by the European Association of Urology. However, the literature analysis and systematic review carried out by our team prove that there are relatively few clinical trials with a well-developed research protocol assessing this form of therapy. In order to objectify the effects of therapy, we will assess both psychosocial aspects, as well as try to answer the question whether biochemical parameters can be a marker of pelvic floor muscles. In previous own research, we obtained promising results by examining biochemical parameters during pelvic floor muscle activity in women with stress urinary incontinence.

Conditions

• Pelvic Floor Disorders
• Urinary Incontinence
• Prostatectomy

Interventions

OTHER

Pre- and post prostatectomy supervised PMFT

intervention before and after surgery, supervised exercises

OTHER

Unsupervised PMFT

intervention after surgery, unsupervised exercises

OTHER

Supervised PMFT

intervention after surgery and supervised exercise

Sponsors & Collaborators

• Nicolaus Copernicus University

  lead OTHER

Principal Investigators

• Agnieszka Radzimińska, PhD · Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz

• Aleksander Goch, Prof. · Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz

• Katarzyna Strojek, PhD · Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz

• Magdalena Weber-Rajek, PhD · Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz

• Agnieszka Strączyńska, PhD · Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz

• Zuzanna Piekorz, PhD · Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz

• Hanna Styczyńska, PhD · Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz

• Piotr Jarzemski, MD, PhD · Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz,

• Stanisław Wroński, MD, PhD · The Jan Biziel Hospital in Bydgoszcz, Department of Urology

• Piotr Słupski, MD · The Jan Biziel Hospital in Bydgoszcz, Department of Urology

• Beata Pilasrka, RN · Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz,

• Marcin Jarzemski, MD · The Jan Biziel Hospital in Bydgoszcz, Department of Urology

• Bartosz Brzoszczyk, MD · The Jan Biziel Hospital in Bydgoszcz, Department of Urology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

40 Years

Max Age

85 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-09-01

Primary Completion

2020-10-31

Completion

2021-09-30

Countries

• Poland

Study Locations