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Educational Program Plus Physiotherapy After Prostatectomy

NCT04284020 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2020-02-25

No results posted yet for this study

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

Interventions

BEHAVIORAL

Therapeutic educational program

See arm/group descriptions

OTHER

PFMT

See arm/group descriptions

OTHER

TTNS

See arm/group descriptions

Sponsors & Collaborators

  • University of Alcala

    lead OTHER

Principal Investigators

  • Maria Torres-Lacomba, PhD · University of Alcalá. FPSM research group. HUPA

  • Beatriz Navarro-Brázalez, PhD · University of Alcalá. FPSM research group. HUPA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04284020 on ClinicalTrials.gov