Educational Program Plus Physiotherapy After Prostatectomy

University of Alcala

Status: Unknown

Conditions: Prostate Cancer; Side Effects

Treatments: Behavioral: Therapeutic educational program; Other: TTNS; Other: PFMT

Study type: Interventional

Funder types: Other

Identifiers

NCT04284020

4/2018

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 2 patient groups

Educational program & pelvic floor muscle training

Experimental group

Description:

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.

Treatment:

Behavioral: Therapeutic educational program

Other: PFMT

Other: TTNS

PFMT group

Active Comparator group

Description:

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.

Treatment:

Other: PFMT

Other: TTNS