Clinical trial NCT05893394: Core Stability as a Prognostic Factor of Urinary Incontinence in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
Official title: Core Stability as a Prognostic Factor of Urinary Incontinence in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 62
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing Robot-Assisted Laparoscopic Prostatectomy

Brief summary: The study aims at investigating the possible correlation between core stability muscles and urinary incontinence following Robot-Assisted Laparoscopic Prostatectomy.

Sixty-two patients who are candidates for Robot-Assisted Laparoscopic Prostatectomy will be enrolled. All participants will be asked to be evaluated in their core stability functionality 30-40 days before Robot-Assisted Laparoscopic Prostatectomy intervention. The core stability functionality result will be correlated with the urinary incontinence 45-50 days after intervention.

Detailed description: The study aims at investigating the correlation between core stability muscles and urinary incontinence following Robot-Assisted Laparoscopic Prostatectomy.

All sixty-two participants will be asked to be evaluated in their core stability functionality 30-40 days before Robot-Assisted Laparoscopic Prostatectomy intervention. Core stability functionality will be evaluated through the Loumajoki Battery of tests, composed of 10 simple items in which the patients have to maintain core stability. In addition a Quality of Life questionnaire (WHO Quality of Life-BREF) will be administered. The core stability functionality result will be correlated with urinary incontinence measured by the 24h PAD test 45-50 days after intervention. At this point core stability will be evaluated again as done before.

Eligibility criteria: Inclusion Criteria:

* Patient who are candidates for Robot-Assisted Laparoscopic Prostatectomy
* Objectivity of core muscles recruitment through the Loumajoki Battery

Exclusion Criteria:

* Pre-surgery incontinence
* Pre-intervention radiotherapy treatment
* Previous urogenital surgery
* Concomitant presence of neurological, internal medicine or musculoskeletal system pathologies that may affect functional or motor recovery
* Subjects with cognitive deficits and/or psychiatric disorders
* Lumbar stabilization or abdominal interventions
* Acute low back pain

Primary outcomes:
measure: Correlation between Core stability functionality and Urinary Incontinence.
timeFrame: Core stability evaluated 30-40 days before surgery. Urinary incontinence evaluated 45-50 days after surgery
Secondary outcomes:
measure: Correlation between Core stability functionality and Quality of Life.
timeFrame: Core stability evaluated 30-40 days before surgery. Quality of Life evaluated 30-40 days before surgery
measure: Variation between Core stability functionality at base line and at follow-up.
timeFrame: Core stability evaluated 30-40 days before surgery and 45-50 days after surgery
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
Study officials:
References: