Clinical trial NCT04172519: Pelvic Floor Muscles Training After Radical Prostatectomy.
Official title: Evaluation of the Effectiveness of Pelvic Floor Muscles Training for Urinary Incontinence After Radical Prostatectomy. Pilot Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Floor Disorders
Urinary Incontinence
Prostatectomy
Keywords: pelvic floor muscles training
laparoscopic radical prostatectomy
adenomectomy
Lead sponsor: Nicolaus Copernicus University
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 76
Sex: MALE
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Parallel crossover study
Primary purpose: TREATMENT

Brief 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.

Detailed description: The subject of the study is to assess the impact of physiotherapeutic intervention in the form of pelvic floor muscle training in patients after laparoscopic radical prostatectomy. A randomized control trials will be carried out on a group of about 300 people (men over 40 years of age) before and after radical prostatectomy. The examined people will be divided into 4 groups and will be assessed before and after surgery: 2 weeks, 6 weeks, 3 months and 6 months. All participants in the study will undergo tests such as: urodynamic, biochemical, MRI, standardized questionnaires regarding the quality of life, physiotherapeutic assessment, histopathological assessment, and cancer progression assessment.

Eligibility criteria: Inclusion Criteria:

* patients diagnosed with prostate cancer qualified for surgery
* patients who underwent radical prostatectomy
* 40-85 years of age.
* patients who gave their written consent to participate in the study
* patient's joining the program will always be preceded by a medical consultation and exclusion of contraindications to therapy
* patients able to understand Polish.

Exclusion Criteria:

* classical retropubic operation,
* classical perineal surgery,
* operation assisted by daVinci robot,
* partial prostate surgery,
* transurethral resection of the prostate (TURP),
* the research will not involve incapacitated persons, soldiers of the basic service, persons deprived of their liberty and remaining in official or other dependence with the persons conducting the examination,
* patient's disagreement to participate in pelvic floor muscle training
* intraoperative and postoperative complications preventing the introduction of early rehabilitation ((damage to the external sphincter, urinary tract infection, bladder neck narrowing),
* prostate cancer recurrence,
* no incontinence after surgery,
* urinary incontinence before surgery,
* previous prostate surgery.

Primary outcomes:
measure: General Self Efficacy Scale (GSES)
timeFrame: 1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
measure: Self Esteem Scale (SES)
timeFrame: 1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
measure: Beck Depression Inventory - II (BDI - II)
timeFrame: 1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
measure: Acceptance of Disease Scale (AIS)
timeFrame: 1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
measure: International Index of Erectile Function - 5 (IIEF - 5)
timeFrame: 1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
measure: Expanded Prostate Cancer Index Composite-26 (EPIC-26)
timeFrame: 1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
measure: EORTC Quality of life Questionnaire -Prostate Cancer Module (EORTC QLQ-PR25)
timeFrame: 1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
measure: EORTC Quality of Life Questionnaire core 30 (EORTC QLQ-C30)
timeFrame: 1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
measure: International Prostate Symptom Score (I-PSS)
timeFrame: 1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
measure: Sex Hormone Binding Globulin (SHGB)
timeFrame: 1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
measure: Luteinizing Hormone (LH)
timeFrame: 1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
measure: Follicle Stimulating Hormone (FSH)
timeFrame: 1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
measure: Free testosterone
timeFrame: 1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
measure: Total testosterone
timeFrame: 1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
measure: Colecalciferol (vitamin D3.)
timeFrame: 1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
measure: Myostatin
timeFrame: 1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
measure: Irisin
timeFrame: 1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
measure: N-terminal telopeptide of type 1 collagen (NTX)
timeFrame: 1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
measure: C-telopeptide of type 1 collagen (CTX)
timeFrame: 1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
measure: Multi-parametric pelvic magnetic resonance (mp NMR)
timeFrame: 2 days
measure: Gleason Score
timeFrame: 1 day
measure: Histopathological examination questionnaire
timeFrame: 1 day
measure: TNM Classification of Malignant Tumors (TNM)
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
facility: The Jan Biziel Hospital, Department of Urology
city: Bydgoszcz
country: Poland
facility: Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz, Department of Physiotherapy
Study officials:
affiliation: Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz
name: Agnieszka Radzimińska, PhD
role: STUDY_DIRECTOR
affiliation: Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz
name: Aleksander Goch, Prof.
role: STUDY_CHAIR
affiliation: Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz
name: Katarzyna Strojek, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz
name: Magdalena Weber-Rajek, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz
name: Agnieszka Strączyńska, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz
name: Zuzanna Piekorz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz
name: Hanna Styczyńska, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz,
name: Piotr Jarzemski, MD, PhD
role: STUDY_DIRECTOR
affiliation: The Jan Biziel Hospital in Bydgoszcz, Department of Urology
name: Stanisław Wroński, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Jan Biziel Hospital in Bydgoszcz, Department of Urology
name: Piotr Słupski, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz,
name: Beata Pilasrka, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: The Jan Biziel Hospital in Bydgoszcz, Department of Urology
name: Marcin Jarzemski, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Jan Biziel Hospital in Bydgoszcz, Department of Urology
name: Bartosz Brzoszczyk, MD
role: PRINCIPAL_INVESTIGATOR
References: