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Core Stability as a Prognostic Factor of Urinary Incontinence in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy

Sponsor
Istituto Clinico Humanitas (Other)
Overall Status
Recruiting
CT.gov ID
NCT05893394
Collaborator
(none)
62
Enrollment
1
Location
9
Anticipated Duration (Months)
6.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    62 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Core Stability as a Prognostic Factor of Urinary Incontinence in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
    Actual Study Start Date :
    Mar 1, 2023
    Anticipated Primary Completion Date :
    Sep 30, 2023
    Anticipated Study Completion Date :
    Nov 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Correlation between Core stability functionality and Urinary Incontinence. [Core stability evaluated 30-40 days before surgery. Urinary incontinence evaluated 45-50 days after surgery]

      To evaluate any correlation between Core stability functionality measured with Loumajoki Battery and Urinary Incontinence measured with 24h PAD test.

    Secondary Outcome Measures

    1. Correlation between Core stability functionality and Quality of Life. [Core stability evaluated 30-40 days before surgery. Quality of Life evaluated 30-40 days before surgery]

      To evaluate any correlation between Core stability functionality measured with Loumajoki Battery and Quality of Life measured with WHO Quality of Life-BREF.

    2. Variation between Core stability functionality at base line and at follow-up. [Core stability evaluated 30-40 days before surgery and 45-50 days after surgery]

      To evaluate any variation between Core stability functionality at base line and at follow-up measured with Loumajoki Battery.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Istituto Clinico Humanitas Rozzano Italy 20089

    Sponsors and Collaborators

    • Istituto Clinico Humanitas

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Istituto Clinico Humanitas
    ClinicalTrials.gov Identifier:
    NCT05893394
    Other Study ID Numbers:
    • CLF 23/01
    First Posted:
    Jun 7, 2023
    Last Update Posted:
    Jun 7, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Urinary Incontinence
    Enuresis

    Study Results

    No Results Posted as of Jun 7, 2023