Educational Program Plus Physiotherapy After Prostatectomy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer; Side Effects
• Intervention / Treatment: Behavioral: Therapeutic educational program; Other: PFMT; Other: TTNS

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cristina Romojaro-Pérez, PhD student; Email: cromojaroperez@gmail.com
• Study Contact Backup: Name: Cristina Romojaro-Pérez, PhD student; Phone Number: 915 75 96 51

Study Locations

• Spain
  • Madrid
    • Alcalá de Henares, Madrid, Spain, 28805
      • Recruiting
      • University of Alcalá. FPSM research group. HUPA
      • Contact: Cristina Romojaro-Pérez, PhD student; Email: cromojaroperez@gmail.com
      • Contact: María Torres-Lacomba, PhD; Email: maria.torres@uah.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Educational program & pelvic floor muscle training; The educational strategy will consist of explaining a healthy lifestyle guide with videos, mobile apps and activities about the anatomy of the pelvic floor and the physiology of the pelvic organs. It will be recommended to avoid risk factors, such as gaining weight, high impact sports, constipation, smoking, or drinking too much caffeine and alcohol. They will also instruct in toilet habits. The pelvic floor muscle training (PFMT) protocol will be applied. Participants will perform exercises with anal biofeedback, perineal and erectile dysfunction electrotherapy protocol and surface electromyography. They will perform PFMT in supine position, sitting, standing and walking. The intervention will last 5 weeks, 2 sessions per week. Each session will last 30/40 minutes. If the patients have overactive bladder symptoms they will perform transcutaneous tibial nerve stimulation (TTNS) protocol. The intervention will last 5 weeks, 2 sessions per week. Each session will last 30 minutes.	Behavioral: Therapeutic educational program; See arm/group descriptions; Other: PFMT; See arm/group descriptions; Other Names: Pelvic floor muscle training; Other: TTNS; See arm/group descriptions; Other Names: Transcutaneous tibial nerve stimulation
Active Comparator: PFMT group; They will receive a basic behavioral educational strategy in the first session including pelvic anatomy and physiology, recommendations to avoid risk factors and toilet habits. The PFMT protocol will be applied. Participants will perform PFMT exercises with anal biofeedback, perineal and erectile dysfunction electrotherapy protocol and surface electromyography. They will perform PFMT in supine position, sitting, standing and walking. The intervention will last 5 weeks, 2 sessions per week. Each session will last 30/40 minutes. If the patients have overactive bladder symptoms they will perform transcutaneous tibial nerve stimulation (TTNS) protocol. The intervention will last 5 weeks, 2 sessions per week. Each session will last 30 minutes.	Other: PFMT; See arm/group descriptions; Other Names: Pelvic floor muscle training; Other: TTNS; See arm/group descriptions; Other Names: Transcutaneous tibial nerve stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: University of Alcala
• Investigators: Study Director: Maria Torres-Lacomba, PhD, University of Alcalá. FPSM research group. HUPA; Study Chair: Beatriz Navarro-Brázalez, PhD, University of Alcalá. FPSM research group. HUPA

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: February 20, 2020
• First Submitted That Met QC Criteria: February 22, 2020
• First Posted (Actual): February 25, 2020

Study Record Updates

• Last Update Posted (Actual): February 25, 2020
• Last Update Submitted That Met QC Criteria: February 22, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 4/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No