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

NCT05893394 | Unknown

• 1 other identifier: CLF 23/01
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing Robot-Assisted Laparoscopic Prostatectomy

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, 20089, Italy

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

roberto gatti

CONTACT

0282245610; roberto.gatti@hunimed.eu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 7, 2023
• Study Start: March 1, 2023
• Primary Completion: September 30, 2023
• Study Completion: November 30, 2023
• Last Updated: June 7, 2023

Record last verified: 2023-05

Locations

IT (1)