Status not kept up to date
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…
Sites
- University of Alcalá. FPSM research group. HUPAAlcalá de Henares, Madrid, Spain
