Evaluation of the Effectiveness of Pelvic Floor Muscles Training for Urinary Incontinence After Radical Prostatectomy. Pilot Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 76
- 试验地点
- 4
- 主要终点
- Free testosterone
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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).
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Free testosterone
时间窗: 1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
The test is performed in cases where the interpretation of total testosterone results is questionable or impossible due to fluctuations in SHBG levels.
Beck Depression Inventory - II (BDI - II)
时间窗: 1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
The BDI questionnaire has been the most widely used self-report depression scale. The tool is used in research on mental disorders and to assess the mood of patients suffering from various medical conditions, including oncological, urological, gynecological, and neurological diseases. The BDI-II questionnaire is a 21-item scale with individual item scores ranging from 0 (no symptoms) to 3 (severe symptoms). A total score of 0-8 is considered as no depression, 9-18 indicates moderate depression, and a score of 18+ is considered as severe depression.
General Self Efficacy Scale (GSES)
时间窗: 1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
The raw scores are afterward transformed into standardized sten scores. The higher the score, the higher are self-efficacy beliefs. Score ranges are defined as follows: 1-4 sten, low scores; 5-6 sten, average scores; and 7-10 sten, high scores.
Acceptance of Disease Scale (AIS)
时间窗: 1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
Acceptance of Disease Scale (AIS) which determines the extent to which the patient accepts his own illness and assesses the severity of negative emotions associated with it. This tool contains 8 statements describing the consequences of the disease. Each statement is scored 1-5 (1- lack of acceptance of the disease; 2-5 good adaptation to the disease situation).
Expanded Prostate Cancer Index Composite-26 (EPIC-26)
时间窗: 1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
EPIC-26, contains five symptom domains (urinary incontinence, urinary irritative/obstructive, sexual, bowel, hormonal), scored from 0 (worst) to 100 (best), that can be tracked over time to understand symptom burden, functional outcomes and the impact of side effect management strategies.
Gleason Score
时间窗: 1 day
The Gleason Score ranges from 1-5 and describes how much the cancer from a biopsy looks like healthy tissue (lower score) or abnormal tissue (higher score). Most cancers score a grade of 3 or higher.
Sex Hormone Binding Globulin (SHGB)
时间窗: 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)
时间窗: 1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
Six milliliters of blood will be collected from each subject after at least 12 hours fasting. Participants had to fast over night with the last meal before 7 pm on the day before the investigation.
International Index of Erectile Function - 5 (IIEF - 5)
时间窗: 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.
EORTC Quality of Life Questionnaire core 30 (EORTC QLQ-C30)
时间窗: 1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
EORTC QLQ-C30 assesses HRQoL in cancer patients with 15 scales, each ranging in scores from 0 to 100.
Luteinizing Hormone (LH)
时间窗: 1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
Six milliliters of blood will be collected from each subject after at least 12 hours fasting. Participants had to fast over night with the last meal before 7 pm on the day before the investigation.
Self Esteem Scale (SES)
时间窗: 1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
General Self-Assessment Level Scale is a tool that allows you to assess the level of general self-assessment. It consists of 10 diagnostic statements. The test is designed to indicate the four-level scale, to what extent patients agree with each of these statements. The raw results obtained are converted into standardized sten standards. The following scoring is taken: 1-4 sten - low results; 5-6 sten - average results; 7-10 sten - high results.
Colecalciferol (vitamin D3.)
时间窗: 1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
In the blood should be in the range of 30-50 nmol / l (20 ng / ml).
EORTC Quality of life Questionnaire -Prostate Cancer Module (EORTC QLQ-PR25)
时间窗: 1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
The prostate-specific module EORTC QLQ-PR25 is a self-administered questionnaire that includes 4 subscales for assessment of Urinary symptoms (9 items, labeled US31-US39), Bowel symptoms (4 items, BS40-BS43), Hormonal treatment-related symptoms (6 items, TS44-TS49), and Sexual activity and function (6 items, SX50-SX55).
International Prostate Symptom Score (I-PSS)
时间窗: 1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).
C-telopeptide of type 1 collagen (CTX)
时间窗: 1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
Morning urine collection
TNM Classification of Malignant Tumors (TNM)
时间窗: 1 day
Small, low-grade cancer, no metastasis, no spread to regional lymph nodes, cancer completely removed, resection material seen by pathologist: pT1 pN0 M0 R0 G1; this grouping of T, N, and M would be considered Stage I. Large, high grade cancer, with spread to regional lymph nodes and other organs, not completely removed, seen by pathologist: pT4 pN2 M1 R1 G3; this grouping of T, N, and M would be considered Stage IV.
Total testosterone
时间窗: 1 day 2 weeks before surgery and assessment of change from baseline at 6 weeks, 3 months and 6 months after operation
Six milliliters of blood will be collected from each subject after at least 12 hours fasting. Participants had to fast over night with the last meal before 7 pm on the day before the investigation.
Myostatin
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 2 days
with evaluation of the prostate gland before surgery and lodge of prostate gland after radical prostatectomy
Histopathological examination questionnaire
时间窗: 1 day
operator's assessment
次要结局
未报告次要终点
研究者
Agnieszka Radzimińska
Study Director
Nicolaus Copernicus University