Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT05311267
Status:
UNKNOWN
Last Update Posted:
2022-04-05
First Post:
2022-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Action Observation Training (AOT) in the Achievement of Urinary Continence in Men After Robot-assisted Laparoscopic Prostatectomy (RALP)
Sponsor:
Istituto Clinico Humanitas
Organization:
Study Overview
Official Title:
Effects of Action Observation Training (AOT) in the Achievement of Urinary Continence in Men After Robot-assisted Laparoscopic Prostatectomy (RALP)
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: