Clinical trial NCT05311267: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Incontinence
Keywords: Robot-assisted Laparoscopic Prostatectomy
Action Observation Training
pelvic floor muscle training
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2022-04-05
Enrollment: 92
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Changes in continence using "24 hours pad test"
timeFrame: 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:
measure: Changes in urinary symptoms using International Prostatic Symptoms Score (IPSS)
timeFrame: 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).
measure: Changes in the quality of life using quality life index (QoL index) 0-6
timeFrame: 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).
measure: Changes in urinary symptoms using International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
timeFrame: 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).
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
Study officials:
References: