Educational Program Plus Physiotherapy After Prostatectomy

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    84
  • sponsor
    University of Alcala
Updated on 23 January 2021
prostatectomy
a 10
impotence
immunological adjuvant

Summary

Objective: to find out the effectiveness of therapeutic education program plus pelvic-perineal physical therapy in radical robotic prostatectomy men in terms of quality of life (QoL), urinary incontinence (UI), erectile dysfunction (ED) and muscle strength.

Design: Randomized, controlled and single blinded clinical trial. Participants will be randomly assigned in two groups. Experimental group: training pelvic-perineal physical therapy plus lifestyle education. Control group: training in pelvic-perineal physical therapy only. In the 2 groups several physical therapy measurements will be undertaken: 1st before physical therapy treatment, 2nd, 3 th and 4th after 3, 6 and 12 months after initial measurement.

Study subjects: Post radical robotic prostatectomy men, which have not been already treated with adjuvant treatment and pelvic-perineal physical therapy, and after reading, understanding and freely signing an informed consent form.

Sample size: 84 subjects will be included (42 subjects per group). To have a statistical power of 90% to detect an average difference of 10 points between two groups in the change of quality of life according to the questionnaire validated in Spanish SF-12, assuming a standard deviation of the change of 20 points based on the study from Hou et al, establishing an alpha risk of 0.05, in a bilateral contrast and assuming a 10% of drops outs.

Data analysis: Separate analyzes of each variable collected in the two groups will be carried out. For continuous variables, means, medians, standard deviations and quartiles will be calculated, depending on the assumption or not, respectively, of the assumption of their normality previously determined with the Shapiro Wilk test (S-W). Qualitative variables will be described with absolute and relative percentage frequencies. Effectiveness will be evaluated by comparing between the two groups of the change in outcome variables between measurements.

Details
Condition Malignant neoplasm of prostate, Prostatic disorder, aspects of adverse effects, Prostate Disorders, Prostate Cancer, Early, Recurrent, Treatment Side Effects, Prostate Cancer, prostate carcinoma, prostate cancers
Treatment TTNS, PFMT, Therapeutic educational program
Clinical Study IdentifierNCT04284020
SponsorUniversity of Alcala
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Men had undergone radical robotic prostate surgery
Men reading, understanding and freely signing an informed consent form

Exclusion Criteria

Participants who had received adjuvant therapies (chemotherapy, radiotherapy) before pelvic-perineal physical therapy treatment
Men with a history of pelvic organ surgery
Men with chronic diseases that affects their quality of life
Participants with psychiatric or neurological problems
Postoperative men with cognitive limitations to understand information, respond to questionnaires, consent and / or participate in the study
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