Educational Program Plus Physiotherapy After Prostatectomy

Not Applicable

• Conditions: Side Effects; Prostate Cancer
• Interventions: Behavioral: Therapeutic educational program; Other: PFMT; Other: TTNS

• Registration Number: NCT04284020
• Lead Sponsor: University of Alcala

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-01
• Status Verified: 2020-02
• Study First Submitted: 2020-02-20
• Study First Submitted QC: 2020-02-22
• Last Update Submitted: 2020-02-22
• Study First Posted: 2020-02-25
• Last Update Posted: 2020-02-25
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Educational program & pelvic floor muscle training	TTNS	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.
PFMT group	TTNS	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.
Educational program & pelvic floor muscle training	Therapeutic educational program	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.
Educational program & pelvic floor muscle training	PFMT	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.
PFMT group	PFMT	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.

Primary Outcome Measures

Name	Time	Method
Change in Prostatic Symptoms	4 measurements to evaluate: before physical therapy treatment, 3 months, 6 months and 12 months after initial measurement.	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.
Change in QoL	4 measurements to evaluate: before physical therapy treatment, 3 months, 6 months and 12 months after initial measurement.	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).
Change in UI	4 measurements to evaluate: before physical therapy treatment, 3 months, 6 months and 12 months after initial measurement.	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.
Change in Pelvic Floor Muscle Strength	4 measurements to evaluate: before physical therapy treatment, 3 months, 6 months and 12 months after initial measurement.	The measuring consists of 4 factors: strength, relax, endurance and repeatability.; It will be measured with manometry (mmHg).
Change in ED	4 measurements to evaluate: before physical therapy treatment, 3 months, 6 months and 12 months after initial measurement.	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).
Assess adherence and satisfaction to treatment	4 measurements to evaluate: before physical therapy treatment, 3 months, 6 months and 12 months after initial measurement.	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).

Trial Locations

Locations (1)

University of Alcalá. FPSM research group. HUPA; 🇪🇸 Alcalá de Henares, Madrid, Spain