Pelvic Floor DisordersNCT04172519
Pelvic Floor Muscles Training After Radical Prostatectomy.
A study testing Pre- and post prostatectomy supervised PMFT, Unsupervised PMFT and Supervised PMFT in people with Pelvic Floor Disorders and Urinary Incontinence, run by Nicolaus Copernicus University at 2 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years, men only
- Conditions the study is for
- Pelvic Floor Disorders, Urinary Incontinence, Prostatectomy
- What is being tested?
- Pre- and post prostatectomy supervised PMFT, Unsupervised PMFT and Supervised PMFT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 2 sitesPoland
- Study dates
- 1 Sep 2018to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
The Jan Biziel Hospital, Department of Urology
Bydgoszcz, 85-168
Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz, Department of Physiotherapy
Bydgoszcz, 85-801
About this study
Official title: 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.
Read the 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.
- Conditions
- Pelvic Floor Disorders, Urinary Incontinence, Prostatectomy
- Being tested
- Pre- and post prostatectomy supervised PMFT, Unsupervised PMFT, Supervised PMFT
- Keywords
- pelvic floor muscles training, laparoscopic radical prostatectomy, adenomectomy
- Medical subject headings
- Pelvic Floor Disorders, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre- and post prostatectomy supervised PMFTOther
intervention before and after surgery, supervised exercises
Unsupervised PMFTOther
intervention after surgery, unsupervised exercises
Supervised PMFTOther
intervention after surgery and supervised exercise
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Supervised PMFT |
| Group D | No intervention | Control group, patients after radical laparoscopic prostatectomy, without additional interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 1 day
Histopathological examination questionnaire
operator's assessment
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start1 Sep 2018
- Primary completionOct 2020 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Parallel crossover study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nicolaus Copernicus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnieszka Radzimińska, Nicolaus Copernicus University
- Investigators
- Agnieszka Radzimińska, PhD, Study director, Nicolaus Copernicus University in Torun Collegium Medicum in BydgoszczAleksander Goch, Prof., Study chair, Nicolaus Copernicus University in Torun Collegium Medicum in BydgoszczKatarzyna Strojek, PhD, Principal investigator, Nicolaus Copernicus University in Torun Collegium Medicum in BydgoszczMagdalena Weber-Rajek, PhD, Principal investigator, Nicolaus Copernicus University in Torun Collegium Medicum in BydgoszczAgnieszka Strączyńska, PhD, Principal investigator, Nicolaus Copernicus University in Torun Collegium Medicum in BydgoszczZuzanna Piekorz, PhD, Principal investigator, Nicolaus Copernicus University in Torun Collegium Medicum in BydgoszczHanna Styczyńska, PhD, Principal investigator, Nicolaus Copernicus University in Torun Collegium Medicum in BydgoszczPiotr Jarzemski, MD, PhD, Study director, Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172519
- Sponsor's protocol ID
- NicolausCU
- Status last verified
- Apr 2020
- First submitted
- 18 Nov 2019
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data, can be available at the request of interested parties.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Pelvic Floor Muscles Training for Urinary Incontinence After Radical Prostatectomy. Pilot Study.
- ClinicalTrials.gov ID
- NCT04172519
- Acronym / sponsor ID
- NicolausCU
- Conditions
- Pelvic Floor Disorders, Urinary Incontinence, Prostatectomy
- Keywords
- pelvic floor muscles training, laparoscopic radical prostatectomy, adenomectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Nicolaus Copernicus UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 21 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Parallel crossover study
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Pre- and post prostatectomy supervised PMFTPatients 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 B | Experimental | Other: Unsupervised PMFTPatients 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. |
| Group C | Experimental | Other: Supervised PMFTPatients 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 D | No intervention | –Control group, patients after radical laparoscopic prostatectomy, without additional interventions |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- classical retropubic operation,
- classical perineal surgery,
- operation assisted by daVinci robot,
- partial prostate surgery,
- transurethral resection of the prostate (TURP),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre- and post prostatectomy supervised PMFTintervention before and after surgery, supervised exercises | Other | Group A |
| Unsupervised PMFTintervention after surgery, unsupervised exercises | Other | Group B |
| Supervised PMFTintervention after surgery and supervised exercise | Other | Group C |
Primary outcome
General Self Efficacy Scale (GSES)
Time frame: 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.
Self Esteem Scale (SES)
Time frame: 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.
Beck Depression Inventory - II (BDI - II)
Time frame: 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.
Acceptance of Disease Scale (AIS)
Time frame: 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).
International Index of Erectile Function - 5 (IIEF - 5)
Time frame: 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.
Expanded Prostate Cancer Index Composite-26 (EPIC-26)
Time frame: 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.
EORTC Quality of life Questionnaire -Prostate Cancer Module (EORTC QLQ-PR25)
Time frame: 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).
EORTC Quality of Life Questionnaire core 30 (EORTC QLQ-C30)
Time frame: 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.
International Prostate Symptom Score (I-PSS)
Time frame: 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).
Sex Hormone Binding Globulin (SHGB)
Time frame: 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.
Luteinizing Hormone (LH)
Time frame: 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)
Time frame: 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.
Free testosterone
Time frame: 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.
Total testosterone
Time frame: 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.
Colecalciferol (vitamin D3.)
Time frame: 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).
Myostatin
Time frame: 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
Time frame: 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.
N-terminal telopeptide of type 1 collagen (NTX)
Time frame: 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
C-telopeptide of type 1 collagen (CTX)
Time frame: 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
Multi-parametric pelvic magnetic resonance (mp NMR)
Time frame: 2 days
with evaluation of the prostate gland before surgery and lodge of prostate gland after radical prostatectomy
Gleason Score
Time frame: 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.
Histopathological examination questionnaire
Time frame: 1 day
operator's assessment
TNM Classification of Malignant Tumors (TNM)
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Individual participant dataSharing planned: No. Individual participant data, can be available at the request of interested parties.
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RecruitingPhase 2
Multimodal Prehabilitation and Rehabilitation for Men Undergoing Robot-Assisted Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Prostate Cancer
Recruiting
Comparing the Effect of Two Types of Pelvic Floor Muscle Stimulation Devices to Improve Symptoms of Urinary Incontinence in Women.
Urinary Incontinence, Mixed Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnieszka Radzimińska, PhD study director
Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz
Aleksander Goch, Prof. study chair
Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz
Katarzyna Strojek, PhD principal investigator
Nicolaus Copernicus University in Torun Collegium Medicum in Bydgoszcz
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre- and post prostatectomy supervised PMFT, Unsupervised PMFT and Supervised PMFT in people with Pelvic Floor Disorders and Urinary Incontinence, run by Nicolaus Copernicus University at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Self Efficacy Scale (GSES) (time frame: 1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.