Educational Program Plus Physiotherapy After Prostatectomy
Efficacy of Therapeutic Education After Radical Robotic Prostate Surgery: Randomized Clinical Trial
1 other identifier
interventional
84
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable prostate-cancer
Started Dec 2019
Typical duration for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2019
CompletedFirst Submitted
Initial submission to the registry
February 20, 2020
CompletedFirst Posted
Study publicly available on registry
February 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedFebruary 25, 2020
February 1, 2020
3.1 years
February 20, 2020
February 22, 2020
Conditions
Outcome Measures
Primary Outcomes (6)
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.
Study Arms (2)
Educational program & pelvic floor muscle training
EXPERIMENTALThe 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.
PFMT group
ACTIVE COMPARATORThey 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.
Interventions
See arm/group descriptions
See arm/group descriptions
See arm/group descriptions
Eligibility Criteria
You may qualify if:
- Men had undergone radical robotic prostate surgery.
- Men reading, understanding and freely signing an informed consent form.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alcalá. FPSM research group. HUPA
Alcalá de Henares, Madrid, 28805, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
February 20, 2020
First Posted
February 25, 2020
Study Start
December 1, 2019
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
February 25, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share