NCT04284020

Educational Program Plus Physiotherapy After Prostatectomy

Efficacy of Therapeutic Education After Radical Robotic Prostate Surgery: Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: University of Alcala · Academic / Other
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer
• Side Effects

Interventions

Type	Name	Description
BEHAVIORAL	Therapeutic educational program	See arm/group descriptions
OTHER	PFMT	See arm/group descriptions
OTHER	TTNS	See arm/group descriptions

Timeline

• Start date: 2019-12-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2020-02-25
• Last updated: 2020-02-25

Locations

1 site across 1 country: Spain