Pelvic Floor Muscles Training After Radical Prostatectomy.

NCT04172519 | Unknown

• 1 other identifier: NicolausCU
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

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.

Conditions

Pelvic Floor Disorders; Urinary Incontinence; Prostatectomy

Keywords

pelvic floor muscles training; laparoscopic radical prostatectomy; adenomectomy

Outcome Measures

Primary Outcomes (23)

• 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

Study Arms (4)

Group A

EXPERIMENTAL

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

Group B

EXPERIMENTAL

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

Group C

EXPERIMENTAL

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

Group D

NO INTERVENTION

Control group, patients after radical laparoscopic prostatectomy, without additional interventions

Interventions

Pre- and post prostatectomy supervised PMFT OTHER

intervention before and after surgery, supervised exercises

Group A

Unsupervised PMFT OTHER

intervention after surgery, unsupervised exercises

Group B

Supervised PMFT OTHER

intervention after surgery and supervised exercise

Group C

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients diagnosed with prostate cancer qualified for surgery
• patients who underwent radical prostatectomy
• years of age.
• patients who gave their written consent to participate in the study
• patients able to understand Polish.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nicolaus Copernicus University: lead

Study Sites (2)

The Jan Biziel Hospital, Department of Urology

Bydgoszcz, 85-168, Poland

Location

Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz, Department of Physiotherapy

Bydgoszcz, 85-801, Poland

Location

MeSH Terms

Conditions

Pelvic Floor Disorders; Urinary Incontinence

Interventions

Lead

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Metals

Study Officials

• Agnieszka Radzimińska, PhD

  Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz

  STUDY DIRECTOR

• Aleksander Goch, Prof.

  Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

• Piotr Jarzemski, MD, PhD

  Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz,

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Stratified randomization was ensured by allocating the subjects using a simple method. One person picked envelopes with group allocation numbers from a computer generated random number table. It should be noted that the main investigator was blinded during the group allocation process. The randomized control trials (RCT) reporting quality has been improved using the CONSORT statement (Consolidated Standards of Reporting Trials).
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director

Model Details: Parallel crossover study

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 21, 2019
• Study Start: September 1, 2018
• Primary Completion: October 1, 2020
• Study Completion: September 1, 2021
• Last Updated: April 7, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)