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

NCT ID: NCT05311267

Last Updated: 2022-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-11-15

Brief Summary

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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.

Detailed Description

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Conditions

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Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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AOT

Participants who, in addiction to standard rehabilitation program after surgery (isometric exercises), underwent two training session of action observation therapy.

Group Type EXPERIMENTAL

Action observation training

Intervention Type OTHER

Subject is asked to observe videos with motor contents

Control group

Participants who received standard rehabilitation program after surgery. The control group, before performing the functional exercises watched two videos of different landscapes lasting 4 minutes each.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Action observation training

Subject is asked to observe videos with motor contents

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Istituto Clinico Humanitas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Istituto Clinico Humanitas

Rozzano, Milano, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Roberto MSc Gatti

Role: CONTACT

0282245610

Facility Contacts

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Roberto Gatti, MSc

Role: primary

Other Identifiers

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751

Identifier Type: -

Identifier Source: org_study_id

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