Pelvic Floor Muscles Training After Radical Prostatectomy.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2021-09-30

Brief Summary

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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.

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Detailed Description

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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

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Pelvic Floor Disorders Urinary Incontinence Prostatectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Parallel crossover study

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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).

Study Groups

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Group A

Patients who before prostate cancer surgery will receive: psychological consultation, nursing consultation, physiotherapy consultation and intervention (4 visits which will be implemented pelvic floor muscle training). Then patients will have radical laparoscopic prostatectomy, after which (after 2 and 6 weeks) they receive psychological consultation, nursing consultation (immediately after surgery) and physiotherapeutic consultation (supervised exercises - meeting twice a week with a physiotherapist, after 2 weeks from surgery for 3 months - 24 interventions, patients for three months additionally perform the recommended exercises 3 times a day at home for 3 months on their own). Then, 6 months after the surgery, there will also be a physiotherapy consultation.

Group Type EXPERIMENTAL

Pre- and post prostatectomy supervised PMFT

Intervention Type OTHER

intervention before and after surgery, supervised exercises

Group B

Patients who will receive: psychological consultation, nursing consultation, physiotherapy consultation before prostate cancer surgery. Subsequently, patients will have the procedure performed laparoscopic radical prostatectomy, immediately after which they receive psychological consultation, nursing consultation. The physiotherapist consultation will be two weeks after the surgery, during which the physiotherapist will provide an instruction pelvic floor muscle training. Patients do the exercises themselves at home according to the instructions, 3 times a day for 3 months). Physiotherapeutic consultation 6 months after surgery.

Group Type EXPERIMENTAL

Unsupervised PMFT

Intervention Type OTHER

intervention after surgery, unsupervised exercises

Group C

Patients who will not receive any intervention before prostate cancer surgery. Then patients will have radical laparoscopic prostatectomy, after which (after 2 and 6 weeks) they receive psychological consultation, nursing consultation (immediately after surgery) and physiotherapeutic consultation (supervised exercises - meeting twice a week with a physiotherapist, after 2 weeks from surgery for 3 months - 24 interventions, patients for three months additionally perform the recommended exercises 3 times a day at home for 3 months on their own). Physiotherapeutic consultation 6 months after surgery.

Group Type EXPERIMENTAL

Supervised PMFT

Intervention Type OTHER

intervention after surgery and supervised exercise

Group D

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pre- and post prostatectomy supervised PMFT

intervention before and after surgery, supervised exercises

Intervention Type OTHER

Unsupervised PMFT

intervention after surgery, unsupervised exercises

Intervention Type OTHER

Supervised PMFT

intervention after surgery and supervised exercise

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Responsible Party

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Agnieszka Radzimińska

Study Director

Responsibility Role PRINCIPAL_INVESTIGATOR