Effects of Action Observation Training (AOT) in the Achievement of Urinary Continence in Men After Robot-assisted Laparoscopic Prostatectomy (RALP)
Primary Purpose
Urinary Incontinence
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Action observation training
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence focused on measuring Robot-assisted Laparoscopic Prostatectomy, Action Observation Training, pelvic floor muscle training
Eligibility Criteria
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
Sites / Locations
- Istituto Clinico HumanitasRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
AOT
Control group
Arm Description
Participants who, in addiction to standard rehabilitation program after surgery (isometric exercises), underwent two training session of action observation therapy.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Changes in urinary symptoms using International Prostatic Symptoms Score (IPSS)
The secondary objective is to investigate urinary symptoms using International Prostatic Symptoms Score (IPSS)
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
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)
Full Information
NCT ID
NCT05311267
First Posted
March 11, 2022
Last Updated
April 4, 2022
Sponsor
Istituto Clinico Humanitas
1. Study Identification
Unique Protocol Identification Number
NCT05311267
Brief Title
Effects of Action Observation Training (AOT) in the Achievement of Urinary Continence in Men After Robot-assisted Laparoscopic Prostatectomy (RALP)
Official Title
Effects of Action Observation Training (AOT) in the Achievement of Urinary Continence in Men After Robot-assisted Laparoscopic Prostatectomy (RALP)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
November 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Clinico Humanitas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
Robot-assisted Laparoscopic Prostatectomy, Action Observation Training, pelvic floor muscle training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AOT
Arm Type
Experimental
Arm Description
Participants who, in addiction to standard rehabilitation program after surgery (isometric exercises), underwent two training session of action observation therapy.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Action observation training
Intervention Description
Subject is asked to observe videos with motor contents
Primary Outcome Measure Information:
Title
Changes in continence using "24 hours pad test"
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Changes in urinary symptoms using International Prostatic Symptoms Score (IPSS)
Description
The secondary objective is to investigate urinary symptoms using International Prostatic Symptoms Score (IPSS)
Time Frame
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).
Title
Changes in the quality of life using quality life index (QoL index) 0-6
Description
The secondary objective is to investigate the quality of life using quality life index 0-6
Time Frame
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).
Title
Changes in urinary symptoms using International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
Description
The secondary objective is to investigate urinary symptoms using International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
Time Frame
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).
10. Eligibility
Sex
Male
Gender Based
Yes
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberto MSc Gatti
Phone
0282245610
Email
Roberto.gatti@hunimed.eu
Facility Information:
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Gatti, MSc
12. IPD Sharing Statement
Learn more about this trial
Effects of Action Observation Training (AOT) in the Achievement of Urinary Continence in Men After Robot-assisted Laparoscopic Prostatectomy (RALP)
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