Effects of Action Observation Training (AOT) in the Achievement of Urinary Continence in Men After Robot-assisted Laparoscopic Prostatectomy (RALP)

Urinary Incontinence Clinical Trial

Official title:

Effects of Action Observation Training (AOT) in the Achievement of Urinary Continence in Men After Robot-assisted Laparoscopic Prostatectomy (RALP)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05311267
• Other study ID #: 751
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: November 15, 2022

Study information

• Verified date: April 2022
• Source: Istituto Clinico Humanitas
• Contact: Roberto MSc Gatti
• Phone: 0282245610
• Email: Roberto.gatti[@]hunimed.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Urinary incontinence (UI) is one of the most common side effects of radical prostatectomy (RP) and compromises men's quality of life. The first line treatment for urinary incontinence is the conservative approach of Pelvic Floor Muscle Training (PFMT) but, up to date, there seems to be no statistically significant difference in the effectiveness of several proposed physiotherapy treatments. Literature highlights the importance of also adding an educational component regarding the intentional contraction of the pelvic floor muscles (a skill termed "the Knack"). Moreover, in some studies, carried out on a sample of women, was introduced the use of virtual reality. This increased the adherence to treatment and showed an improvement in urinary continence. In addition to virtual reality, another intervention methodology used in physiotherapy is the one of Action Observation training (AOT) whose effectiveness has been proven both in sports and rehabilitation. However, currently the effect of this innovative type of treatment has not yet been studied in men with UI following radical prostatectomy intervention. The aim of this clinical study is to investigate the effectiveness of using AOT on urinary incontinence in subjects undergoing robotic radical prostatectomy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: November 15, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients who have undergone Robot-assisted Laparoscopic Prostatectomy with post-operative IU.
• Objectivity of recruitment and contraction of pelvic floor musculature (PP) at manual perineal testing.

Exclusion Criteria:

• Preoperative incontinence
• Pre-intervention radiotherapy
• Previous urogenital surgery beyond Robot-assisted Laparoscopic Prostatectomy.
• Concomitant presence of neurological, internal or musculoskeletal diseases that may affect functional or motor recovery.
• Less than 5 seconds of endurance in PP contraction

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

Other:
• Action observation training
Subject is asked to observe videos with motor contents

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in continence using "24 hours pad test"	The primary outcome is to investigate if there is a difference in continence between the experimental and the control group at each physiotherapy session and compared to the baseline (T0).To quantify the extent of these losses, the weight of absorbent devices used by patients in the 24 hours prior to each evaluation will be measured.	Both groups will be evaluated 45 days after surgery (T0), 1-week after T0 (T1), 2 weeks after T0 (T2), 4 weeks after T0 (T4), 6 weeks after T0 (T6) and 8 weeks after T0 (T8), 3 months after T8 (T9).
Secondary	Changes in urinary symptoms using International Prostatic Symptoms Score (IPSS)	The secondary objective is to investigate urinary symptoms using International Prostatic Symptoms Score (IPSS)	Both groups will be evaluated 45 days after surgery (T0), 8 weeks after T0 (T8) or earlier in case of achievement of the primary goal in previous sessions (T1, T2, T4, T6), and 3 months after T8 (T9).
Secondary	Changes in the quality of life using quality life index (QoL index) 0-6	The secondary objective is to investigate the quality of life using quality life index 0-6	Both groups will be evaluated 45 days after surgery (T0), 8 weeks after T0 (T8) or earlier in case of achievement of the primary goal in previous sessions (T1, T2, T4, T6), and 3 months after T8 (T9).
Secondary	Changes in urinary symptoms using International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)	The secondary objective is to investigate urinary symptoms using International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)	Both groups will be evaluated 45 days after surgery (T0), 8 weeks after T0 (T8) or earlier in case of achievement of the primary goal in previous sessions (T1, T2, T4, T6), and 3 months after T8 (T9).