Pelvic Floor Muscles Training After Radical Prostatectomy.

Evaluation of the Effectiveness of Pelvic Floor Muscles Training for Urinary Incontinence After Radical Prostatectomy. Pilot Study.

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.

Study Overview

• Status: Unknown
• Conditions: Urinary Incontinence; Pelvic Floor Disorders; Prostatectomy
• Intervention / Treatment: Other: Pre- and post prostatectomy supervised PMFT; Other: Unsupervised PMFT; Other: Supervised PMFT

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 Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Bydgoszcz, Poland, 85-168
    • The Jan Biziel Hospital, Department of Urology
  • Bydgoszcz, Poland, 85-801
    • Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz, Department of Physiotherapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; 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.	Other: Pre- and post prostatectomy supervised PMFT; intervention before and after surgery, supervised exercises
Experimental: Group B; 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.	Other: Unsupervised PMFT; intervention after surgery, unsupervised exercises
Experimental: Group C; 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.	Other: Supervised PMFT; intervention after surgery and supervised exercise
No Intervention: Group D; Control group, patients after radical laparoscopic prostatectomy, without additional interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General Self Efficacy Scale (GSES)	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.	1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
Self Esteem Scale (SES)	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.	1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
Beck Depression Inventory - II (BDI - II)	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.	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)	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).	1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
International Index of Erectile Function - 5 (IIEF - 5)	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.	1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
Expanded Prostate Cancer Index Composite-26 (EPIC-26)	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.	1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
EORTC Quality of life Questionnaire -Prostate Cancer Module (EORTC QLQ-PR25)	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).	1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
EORTC Quality of Life Questionnaire core 30 (EORTC QLQ-C30)	EORTC QLQ-C30 assesses HRQoL in cancer patients with 15 scales, each ranging in scores from 0 to 100.	1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
International Prostate Symptom Score (I-PSS)	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).	1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
Sex Hormone Binding Globulin (SHGB)	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.	1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
Luteinizing Hormone (LH)	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.	1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
Follicle Stimulating Hormone (FSH)	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.	1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
Free testosterone	The test is performed in cases where the interpretation of total testosterone results is questionable or impossible due to fluctuations in SHBG levels.	1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
Total testosterone	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.	1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
Colecalciferol (vitamin D3.)	In the blood should be in the range of 30-50 nmol / l (20 ng / ml).	1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
Myostatin	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.	1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
Irisin	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.	1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
N-terminal telopeptide of type 1 collagen (NTX)	Morning urine collection	1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
C-telopeptide of type 1 collagen (CTX)	Morning urine collection	1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
Multi-parametric pelvic magnetic resonance (mp NMR)	with evaluation of the prostate gland before surgery and lodge of prostate gland after radical prostatectomy	2 days
Gleason Score	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.	1 day
Histopathological examination questionnaire	operator's assessment	1 day
TNM Classification of Malignant Tumors (TNM)	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.	1 day

Collaborators and Investigators

• Sponsor: Nicolaus Copernicus University
• Investigators: Study Director: Agnieszka Radzimińska, PhD, Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz; Study Chair: Aleksander Goch, Prof., Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz; Principal Investigator: Katarzyna Strojek, PhD, Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz; Principal Investigator: Magdalena Weber-Rajek, PhD, Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz; Principal Investigator: Agnieszka Strączyńska, PhD, Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz; Principal Investigator: Zuzanna Piekorz, PhD, Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz; Principal Investigator: Hanna Styczyńska, PhD, Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz; Study Director: Piotr Jarzemski, MD, PhD, Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz,; Principal Investigator: Stanisław Wroński, MD, PhD, The Jan Biziel Hospital in Bydgoszcz, Department of Urology; Principal Investigator: Piotr Słupski, MD, The Jan Biziel Hospital in Bydgoszcz, Department of Urology; Principal Investigator: Beata Pilasrka, RN, Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz,; Principal Investigator: Marcin Jarzemski, MD, The Jan Biziel Hospital in Bydgoszcz, Department of Urology; Principal Investigator: Bartosz Brzoszczyk, MD, The Jan Biziel Hospital in Bydgoszcz, Department of Urology

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: November 18, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (Actual): November 21, 2019

Study Record Updates

• Last Update Posted (Actual): April 7, 2020
• Last Update Submitted That Met QC Criteria: April 4, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: pelvic floor muscles training; laparoscopic radical prostatectomy; adenomectomy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Pregnancy Complications; Elimination Disorders; Urinary Incontinence; Enuresis; Pelvic Floor Disorders
• Other Study ID Numbers: NicolausCU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual participant data, can be available at the request of interested parties.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No