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

NCT05311267 | Unknown

• 1 other identifier: 751
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence

Keywords

Robot-assisted Laparoscopic Prostatectomy; Action Observation Training; pelvic floor muscle training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Changes in 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).

• Changes in the quality of life using quality life index (QoL 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).

• Changes in 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).

Study Arms (2)

AOT

EXPERIMENTAL

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

Other: Action observation training

Control group

NO INTERVENTION

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.

Interventions

Action observation training OTHER

Subject is asked to observe videos with motor contents

AOT

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Roberto MSc Gatti

CONTACT

0282245610; Roberto.gatti@hunimed.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: April 5, 2022
• Study Start: October 1, 2020
• Primary Completion: September 30, 2022
• Study Completion: November 15, 2022
• Last Updated: April 5, 2022

Record last verified: 2022-04

Locations

IT (1)