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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05893394
Other study ID # CLF 23/01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2023
Est. completion date November 30, 2023

Study information

Verified date May 2023
Source Istituto Clinico Humanitas
Contact roberto gatti
Phone 0282245610
Email roberto.gatti@hunimed.eu
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 62
Est. completion date November 30, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy Istituto Clinico Humanitas Rozzano

Sponsors (1)

Lead Sponsor Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation between Core stability functionality and Urinary Incontinence. To evaluate any correlation between Core stability functionality measured with Loumajoki Battery and Urinary Incontinence measured with 24h PAD test. Core stability evaluated 30-40 days before surgery. Urinary incontinence evaluated 45-50 days after surgery
Secondary Correlation between Core stability functionality and Quality of Life. To evaluate any correlation between Core stability functionality measured with Loumajoki Battery and Quality of Life measured with WHO Quality of Life-BREF. Core stability evaluated 30-40 days before surgery. Quality of Life evaluated 30-40 days before surgery
Secondary Variation between Core stability functionality at base line and at follow-up. To evaluate any variation between Core stability functionality at base line and at follow-up measured with Loumajoki Battery. Core stability evaluated 30-40 days before surgery and 45-50 days after surgery
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