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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05893394
• Other study ID #: CLF 23/01
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Enuresis
• Prostate Cancer
• Urinary Incontinence

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