Pelvic Floor Muscles Training After Radical Prostatectomy.

Not Applicable

• Conditions: Urinary Incontinence; Pelvic Floor Disorders; Prostatectomy
• Interventions: Other: Pre- and post prostatectomy supervised PMFT; Other: Supervised PMFT; Other: Unsupervised PMFT

• Registration Number: NCT04172519
• Lead Sponsor: Nicolaus Copernicus University

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.

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2019-11-18
• Study First Submitted QC: 2019-11-19
• Study First Posted: 2019-11-21
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-04
• Last Update Posted: 2020-04-07
• Primary Completion: 2020-10
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 76

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A	Pre- and post prostatectomy supervised PMFT	Patients who before prostate cancer surgery will receive: psychological consultation, nursing consultation, physiotherapy consultation and intervention (4 visits which will be implemented pelvic floor muscle training). Then patients will have radical laparoscopic prostatectomy, after which (after 2 and 6 weeks) they receive psychological consultation, nursing consultation (immediately after surgery) and physiotherapeutic consultation (supervised exercises - meeting twice a week with a physiotherapist, after 2 weeks from surgery for 3 months - 24 interventions, patients for three months additionally perform the recommended exercises 3 times a day at home for 3 months on their own). Then, 6 months after the surgery, there will also be a physiotherapy consultation.
Group C	Supervised PMFT	Patients who will not receive any intervention before prostate cancer surgery. Then patients will have radical laparoscopic prostatectomy, after which (after 2 and 6 weeks) they receive psychological consultation, nursing consultation (immediately after surgery) and physiotherapeutic consultation (supervised exercises - meeting twice a week with a physiotherapist, after 2 weeks from surgery for 3 months - 24 interventions, patients for three months additionally perform the recommended exercises 3 times a day at home for 3 months on their own). Physiotherapeutic consultation 6 months after surgery.
Group B	Unsupervised PMFT	Patients who will receive: psychological consultation, nursing consultation, physiotherapy consultation before prostate cancer surgery. Subsequently, patients will have the procedure performed laparoscopic radical prostatectomy, immediately after which they receive psychological consultation, nursing consultation. The physiotherapist consultation will be two weeks after the surgery, during which the physiotherapist will provide an instruction pelvic floor muscle training. Patients do the exercises themselves at home according to the instructions, 3 times a day for 3 months). Physiotherapeutic consultation 6 months after surgery.

Primary Outcome Measures

Name	Time	Method
Free testosterone	1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation	The test is performed in cases where the interpretation of total testosterone results is questionable or impossible due to fluctuations in SHBG levels.
Beck Depression Inventory - II (BDI - II)	1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation	The BDI questionnaire has been the most widely used self-report depression scale. The tool is used in research on mental disorders and to assess the mood of patients suffering from various medical conditions, including oncological, urological, gynecological, and neurological diseases. The BDI-II questionnaire is a 21-item scale with individual item scores ranging from 0 (no symptoms) to 3 (severe symptoms). A total score of 0-8 is considered as no depression, 9-18 indicates moderate depression, and a score of 18+ is considered as severe depression.
General Self Efficacy Scale (GSES)	1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation	The raw scores are afterward transformed into standardized sten scores. The higher the score, the higher are self-efficacy beliefs. Score ranges are defined as follows: 1-4 sten, low scores; 5-6 sten, average scores; and 7-10 sten, high scores.
Acceptance of Disease Scale (AIS)	1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation	Acceptance of Disease Scale (AIS) which determines the extent to which the patient accepts his own illness and assesses the severity of negative emotions associated with it. This tool contains 8 statements describing the consequences of the disease. Each statement is scored 1-5 (1- lack of acceptance of the disease; 2-5 good adaptation to the disease situation).
Expanded Prostate Cancer Index Composite-26 (EPIC-26)	1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation	EPIC-26, contains five symptom domains (urinary incontinence, urinary irritative/obstructive, sexual, bowel, hormonal), scored from 0 (worst) to 100 (best), that can be tracked over time to understand symptom burden, functional outcomes and the impact of side effect management strategies.
Gleason Score	1 day	The Gleason Score ranges from 1-5 and describes how much the cancer from a biopsy looks like healthy tissue (lower score) or abnormal tissue (higher score). Most cancers score a grade of 3 or higher.
Sex Hormone Binding Globulin (SHGB)	1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation	Six milliliters of blood will be collected from each subject after at least 12 hours fasting. Participants had to fast over night with the last meal before 7 pm on the day before the investigation.
Follicle Stimulating Hormone (FSH)	1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation	Six milliliters of blood will be collected from each subject after at least 12 hours fasting. Participants had to fast over night with the last meal before 7 pm on the day before the investigation.
International Index of Erectile Function - 5 (IIEF - 5)	1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation	The International Index of Erectile Function - 5, which consists of 15 items and 5 domains, is a psychometrically valid and reliable instrument that was developed through consultations with an international panel of experts for use in determining efficacy of treatment in controlled clinical trials.
N-terminal telopeptide of type 1 collagen (NTX)	1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation	Morning urine collection
EORTC Quality of Life Questionnaire core 30 (EORTC QLQ-C30)	1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation	EORTC QLQ-C30 assesses HRQoL in cancer patients with 15 scales, each ranging in scores from 0 to 100.
Luteinizing Hormone (LH)	1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation	Six milliliters of blood will be collected from each subject after at least 12 hours fasting. Participants had to fast over night with the last meal before 7 pm on the day before the investigation.
Self Esteem Scale (SES)	1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation	General Self-Assessment Level Scale is a tool that allows you to assess the level of general self-assessment. It consists of 10 diagnostic statements. The test is designed to indicate the four-level scale, to what extent patients agree with each of these statements. The raw results obtained are converted into standardized sten standards. The following scoring is taken: 1-4 sten - low results; 5-6 sten - average results; 7-10 sten - high results.
Colecalciferol (vitamin D3.)	1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation	In the blood should be in the range of 30-50 nmol / l (20 ng / ml).
EORTC Quality of life Questionnaire -Prostate Cancer Module (EORTC QLQ-PR25)	1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation	The prostate-specific module EORTC QLQ-PR25 is a self-administered questionnaire that includes 4 subscales for assessment of Urinary symptoms (9 items, labeled US31-US39), Bowel symptoms (4 items, BS40-BS43), Hormonal treatment-related symptoms (6 items, TS44-TS49), and Sexual activity and function (6 items, SX50-SX55).
International Prostate Symptom Score (I-PSS)	1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation	Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).
C-telopeptide of type 1 collagen (CTX)	1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation	Morning urine collection
TNM Classification of Malignant Tumors (TNM)	1 day	Small, low-grade cancer, no metastasis, no spread to regional lymph nodes, cancer completely removed, resection material seen by pathologist: pT1 pN0 M0 R0 G1; this grouping of T, N, and M would be considered Stage I.; Large, high grade cancer, with spread to regional lymph nodes and other organs, not completely removed, seen by pathologist: pT4 pN2 M1 R1 G3; this grouping of T, N, and M would be considered Stage IV.
Total testosterone	1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation	Six milliliters of blood will be collected from each subject after at least 12 hours fasting. Participants had to fast over night with the last meal before 7 pm on the day before the investigation.
Myostatin	1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation	Six milliliters of blood will be collected from each subject after at least 12 hours fasting into Vacuette tubes with EDTA anticoagulant. Participants had to fast over night with the last meal before 7 pm on the day before the investigation.
Irisin	1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation	Six milliliters of blood will be collected from each subject after at least 12 hours fasting into Vacuette tubes with EDTA anticoagulant. Participants had to fast over night with the last meal before 7 pm on the day before the investigation.
Multi-parametric pelvic magnetic resonance (mp NMR)	2 days	with evaluation of the prostate gland before surgery and lodge of prostate gland after radical prostatectomy
Histopathological examination questionnaire	1 day	operator's assessment

Trial Locations

Locations (2)

The Jan Biziel Hospital, Department of Urology; 🇵🇱 Bydgoszcz, Poland

Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz, Department of Physiotherapy; 🇵🇱 Bydgoszcz, Poland