Educational Program Plus Physiotherapy After Prostatectomy

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04284020
• Other study ID #: 4/2018
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2020
• Source: University of Alcala
• Contact: Cristina Romojaro-Pérez, PhD student
• Email: cromojaroperez[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Side Effects

Intervention

Behavioral:
• Therapeutic educational program
See arm/group descriptions

Other:
• PFMT
See arm/group descriptions
• TTNS
See arm/group descriptions

Locations

Country	Name	City	State
Spain	University of Alcalá. FPSM research group. HUPA	Alcalá de Henares	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
University of Alcala

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in QoL	It will be assessed by Short Form 12 (SF-12) Spanish version. The SF-12 consist in 12 items of 8 dimensions: 2 items about physical function, 1 item about social function, 2 items about physical role, 2 items about emotional role, 2 items about mental health, 1 item about vitality, 1 items about body pain, 1 item about general health. The 8 dimensions are scored from 0 (bad health) to 100 (optimal state of health).	4 measurements to evaluate: before physical therapy treatment, 3 months, 6 months and 12 months after initial measurement.
Primary	Change in UI	It will be assessed by International Consultation on Incontinence Questionnaire Urinary Incontinence (ICIQ-UI) Spanish version.; The ICIQ-UI SF consist in 3 items (Frequency, Quantity and Impact) and 8 questions to identify the UI type. The 3 items are scored from 0 (no incontinence) to 21 (severe incontinence).; It will be assessed by 1 hour Pad Test. The Pad test consists in weigh a compress after being used under standardized conditions.	4 measurements to evaluate: before physical therapy treatment, 3 months, 6 months and 12 months after initial measurement.
Primary	Change in Prostatic Symptoms	It will be assessed by International Prostate Symptom Score (IPSS) Spanish version.; The IPSS consist of 6 items plus one about quality of life. The 6 items are scored from 1-7 (mild symptomatology), 8-19 (moderate symptomatology) to 20-35 (severe symptomatology).The item about quality of life is measured qualitatively.	4 measurements to evaluate: before physical therapy treatment, 3 months, 6 months and 12 months after initial measurement.
Primary	Change in Pelvic Floor Muscle Strength	The measuring consists of 4 factors: strength, relax, endurance and repeatability.; It will be measured with manometry (mmHg).	4 measurements to evaluate: before physical therapy treatment, 3 months, 6 months and 12 months after initial measurement.
Primary	Change in ED	It will be assessed by Short Questionnaire for Erectile Dysfunction (SQUED) Spanish version.; The SQUED consist of 3 items. The 3 items are scored from 0 (severe dysfunction) to 15 (no dysfunction).	4 measurements to evaluate: before physical therapy treatment, 3 months, 6 months and 12 months after initial measurement.
Primary	Assess adherence and satisfaction to treatment	It will be assessed by benefit, satisfaction and willingness to continue treatment questionnaire (BSD) Spanish version.; The BSD consist of 3 items: perception of the benefit, satisfaction with the treatment and willingness of the patient to continue with the treatment.; The 3 items are scored from 0 (no satisfaction and no adherence) to 10 (much satisfaction and adherence).	4 measurements to evaluate: before physical therapy treatment, 3 months, 6 months and 12 months after initial measurement.