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Pelvic Floor Muscles Training After Radical Prostatectomy.

Primary Purpose

Pelvic Floor Disorders, Urinary Incontinence, Prostatectomy

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Pre- and post prostatectomy supervised PMFT
Unsupervised PMFT
Supervised PMFT
Sponsored by
Nicolaus Copernicus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Floor Disorders focused on measuring pelvic floor muscles training, laparoscopic radical prostatectomy, adenomectomy

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • The Jan Biziel Hospital, Department of Urology
  • Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz, Department of Physiotherapy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Group A

Group B

Group C

Group D

Arm Description

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.

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.

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.

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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).
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.
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.
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).
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.
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).
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.
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.
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.
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.
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.
Colecalciferol (vitamin D3.)
In the blood should be in the range of 30-50 nmol / l (20 ng / ml).
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.
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.
N-terminal telopeptide of type 1 collagen (NTX)
Morning urine collection
C-telopeptide of type 1 collagen (CTX)
Morning urine collection
Multi-parametric pelvic magnetic resonance (mp NMR)
with evaluation of the prostate gland before surgery and lodge of prostate gland after radical prostatectomy
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.
Histopathological examination questionnaire
operator's assessment
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.

Secondary Outcome Measures

Full Information

First Posted
November 18, 2019
Last Updated
April 4, 2020
Sponsor
Nicolaus Copernicus University
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1. Study Identification

Unique Protocol Identification Number
NCT04172519
Brief Title
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

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nicolaus Copernicus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Disorders, Urinary Incontinence, Prostatectomy
Keywords
pelvic floor muscles training, laparoscopic radical prostatectomy, adenomectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Parallel crossover study
Masking
ParticipantOutcomes Assessor
Masking Description
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).
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B
Arm Type
Experimental
Arm Description
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.
Arm Title
Group C
Arm Type
Experimental
Arm Description
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.
Arm Title
Group D
Arm Type
No Intervention
Arm Description
Control group, patients after radical laparoscopic prostatectomy, without additional interventions
Intervention Type
Other
Intervention Name(s)
Pre- and post prostatectomy supervised PMFT
Intervention Description
intervention before and after surgery, supervised exercises
Intervention Type
Other
Intervention Name(s)
Unsupervised PMFT
Intervention Description
intervention after surgery, unsupervised exercises
Intervention Type
Other
Intervention Name(s)
Supervised PMFT
Intervention Description
intervention after surgery and supervised exercise
Primary Outcome Measure Information:
Title
General Self Efficacy Scale (GSES)
Description
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.
Time Frame
1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
Title
Self Esteem Scale (SES)
Description
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.
Time Frame
1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
Title
Beck Depression Inventory - II (BDI - II)
Description
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.
Time Frame
1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
Title
Acceptance of Disease Scale (AIS)
Description
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).
Time Frame
1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
Title
International Index of Erectile Function - 5 (IIEF - 5)
Description
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.
Time Frame
1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
Title
Expanded Prostate Cancer Index Composite-26 (EPIC-26)
Description
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.
Time Frame
1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
Title
EORTC Quality of life Questionnaire -Prostate Cancer Module (EORTC QLQ-PR25)
Description
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).
Time Frame
1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
Title
EORTC Quality of Life Questionnaire core 30 (EORTC QLQ-C30)
Description
EORTC QLQ-C30 assesses HRQoL in cancer patients with 15 scales, each ranging in scores from 0 to 100.
Time Frame
1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
Title
International Prostate Symptom Score (I-PSS)
Description
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).
Time Frame
1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
Title
Sex Hormone Binding Globulin (SHGB)
Description
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.
Time Frame
1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
Title
Luteinizing Hormone (LH)
Description
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.
Time Frame
1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
Title
Follicle Stimulating Hormone (FSH)
Description
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.
Time Frame
1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
Title
Free testosterone
Description
The test is performed in cases where the interpretation of total testosterone results is questionable or impossible due to fluctuations in SHBG levels.
Time Frame
1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
Title
Total testosterone
Description
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.
Time Frame
1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
Title
Colecalciferol (vitamin D3.)
Description
In the blood should be in the range of 30-50 nmol / l (20 ng / ml).
Time Frame
1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
Title
Myostatin
Description
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.
Time Frame
1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
Title
Irisin
Description
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.
Time Frame
1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
Title
N-terminal telopeptide of type 1 collagen (NTX)
Description
Morning urine collection
Time Frame
1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
Title
C-telopeptide of type 1 collagen (CTX)
Description
Morning urine collection
Time Frame
1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
Title
Multi-parametric pelvic magnetic resonance (mp NMR)
Description
with evaluation of the prostate gland before surgery and lodge of prostate gland after radical prostatectomy
Time Frame
2 days
Title
Gleason Score
Description
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.
Time Frame
1 day
Title
Histopathological examination questionnaire
Description
operator's assessment
Time Frame
1 day
Title
TNM Classification of Malignant Tumors (TNM)
Description
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.
Time Frame
1 day

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnieszka Radzimińska, PhD
Organizational Affiliation
Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Aleksander Goch, Prof.
Organizational Affiliation
Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Katarzyna Strojek, PhD
Organizational Affiliation
Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Magdalena Weber-Rajek, PhD
Organizational Affiliation
Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Agnieszka Strączyńska, PhD
Organizational Affiliation
Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zuzanna Piekorz, PhD
Organizational Affiliation
Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hanna Styczyńska, PhD
Organizational Affiliation
Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Piotr Jarzemski, MD, PhD
Organizational Affiliation
Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz,
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Stanisław Wroński, MD, PhD
Organizational Affiliation
The Jan Biziel Hospital in Bydgoszcz, Department of Urology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Piotr Słupski, MD
Organizational Affiliation
The Jan Biziel Hospital in Bydgoszcz, Department of Urology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Beata Pilasrka, RN
Organizational Affiliation
Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz,
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marcin Jarzemski, MD
Organizational Affiliation
The Jan Biziel Hospital in Bydgoszcz, Department of Urology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bartosz Brzoszczyk, MD
Organizational Affiliation
The Jan Biziel Hospital in Bydgoszcz, Department of Urology
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Jan Biziel Hospital, Department of Urology
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz, Department of Physiotherapy
City
Bydgoszcz
ZIP/Postal Code
85-801
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data, can be available at the request of interested parties.

Learn more about this trial

Pelvic Floor Muscles Training After Radical Prostatectomy.

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