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Trial Title:
Core Stability as a Prognostic Factor of Urinary Incontinence in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
NCT ID:
NCT05893394
Condition:
Prostate Cancer
Conditions: Official terms:
Urinary Incontinence
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Patients undergoing Robot-Assisted Laparoscopic Prostatectomy
Sampling method:
Probability Sample
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
Gender:
Male
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Istituto Clinico Humanitas
Address:
City:
Rozzano
Zip:
20089
Country:
Italy
Status:
Recruiting
Contact:
Last name:
roberto gatti
Phone:
0282245610
Email:
roberto.gatti@hunimed.eu
Start date:
March 1, 2023
Completion date:
November 30, 2023
Lead sponsor:
Agency:
Istituto Clinico Humanitas
Agency class:
Other
Source:
Istituto Clinico Humanitas
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05893394
