Clinical trial NCT04284020: Educational Program Plus Physiotherapy After Prostatectomy
Official title: Efficacy of Therapeutic Education After Radical Robotic Prostate Surgery: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Side Effects
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2020-02-25
Enrollment: 84
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups: 1 experimental and 1 control group
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in QoL
timeFrame: 4 measurements to evaluate: before physical therapy treatment, 3 months, 6 months and 12 months after initial measurement.
measure: Change in UI
timeFrame: 4 measurements to evaluate: before physical therapy treatment, 3 months, 6 months and 12 months after initial measurement.
measure: Change in Prostatic Symptoms
timeFrame: 4 measurements to evaluate: before physical therapy treatment, 3 months, 6 months and 12 months after initial measurement.
measure: Change in Pelvic Floor Muscle Strength
timeFrame: 4 measurements to evaluate: before physical therapy treatment, 3 months, 6 months and 12 months after initial measurement.
measure: Change in ED
timeFrame: 4 measurements to evaluate: before physical therapy treatment, 3 months, 6 months and 12 months after initial measurement.
measure: Assess adherence and satisfaction to treatment
timeFrame: 4 measurements to evaluate: before physical therapy treatment, 3 months, 6 months and 12 months after initial measurement.
Secondary outcomes:
Other outcomes:
Locations:
city: Alcalá de Henares
country: Spain
facility: University of Alcalá. FPSM research group. HUPA
state: Madrid
Study officials:
affiliation: University of Alcalá. FPSM research group. HUPA
name: Maria Torres-Lacomba, PhD
role: STUDY_DIRECTOR
affiliation: University of Alcalá. FPSM research group. HUPA
name: Beatriz Navarro-Brázalez, PhD
role: STUDY_CHAIR
References: