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Educational Program Plus Physiotherapy After Prostatectomy

NCT04284020 · University of Alcala · Updated 25 Feb 2020

What is being tested
Therapeutic educational program; PFMT; TTNS
For
Prostate Cancer; Side Effects
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years to 75 years. About 84 people. The full rules are on the registry page.
Where
Spain
When
Starts or started 1 Dec 2019, ends 31 Dec 2022. Registered 25 Feb 2020.
Results
None posted yet.

In the researchers' words

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…
ClinicalTrials.gov, NCT04284020

Sites

  • University of Alcalá. FPSM research group. HUPAAlcalá de Henares, Madrid, Spain