Effects of High-Intensity Focused Ultrasound (HIFU) Treatment on Fecal Continence and Anorretal Fisiology
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Anal sphicter evaluation
Study Overview
Brief Summary
Investigate the presence of hypotonic anal sphincter after anorectal dilatation and High-Intensity Focused Ultrasound (HiFU) , through the aplication of questionnaires and Anorectal Manometry before and after this treatment.
Detailed Description
Primary Investigate the presence of hypotonic anal sphincter after anorectal dilatation and HiFU procedure
Secondary
- Detect the presence of fecal incontinence
- Demonstrate the absence of alterations in the fecal pattern
- Detect alterations in rectal filling sensation and e evacuation desire
- Evaluate anal pain
PATIENTS AND METHODS Thirty (30) consecutive patients indicated for treatment of prostate cancer with HIFU (FocalOneR, Edap TMS, France) will be selected. The specific inclusion and exclusion criteria are specified below. All should present the diagnosis of usual acinar adenocarcinoma of prostate Gleason score 6 (3 + 3) or Gleason 7 (3 + 4). No patient may have PSA greater than 10.0. A digital prostate exam should show prostate-restricted disease. The clinical staging should be ≤ cT2a. There will be no age limit for inclusion. Patients may not have anatomical, functional or pathological alterations of the anal canal and rectus or history of anorectal trauma and may not have a diagnosis of psychoneurologic diseases, such as: Depression, Stroke, Schizophrenia, Degenerative Neurological Diseases or others.
All patients will be submitted to the manometry study the week prior to HIFU together with the application of specific questionnaires (Cleveland Clinic Incontinence Score-CCIS, Fecal Incontinence Quality of Life Score-FIQLS, and Rome IV for functional constipation. This examination will be conducted in a friendly environment and by experienced professionals.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients of any age with diagnosis of usual acinar adenocarcinoma of the prostate;
- •Patients that treatment with HIFU is an option;
- •And, that they accept to undergo the pre-and post-HIFU anorectal manometry;
- •And, answer the questionnaires applied;
- •And, signature of the informed consent form.
Exclusion Criteria
- •Patients who have no indication of HIFU treatment;
- •Or, who have already undergone some anorectal surgery;
- •Or, that they present some psychoneurological disease;
- •Or, who have anatomical, functional or pathological alterations of the rectum or anal;
Arms & Interventions
Experimental Group
Thirty (30) consecutive patients indicated for treatment of prostate cancer with HIFU (FocalOneR, Edap TMS, France) will be selected to the manometry study before the treatment together with the application of specific questionnaires (Cleveland Clinic Incontinence Score-CCIS, Fecal Incontinence Quality of Life Score-FIQLS, and Rome IV for functional constipation. This evaluaton will be conducted again after the treatment.
Intervention: Anal Manometry (Diagnostic Test)
Outcomes
Primary Outcomes
Anal sphicter evaluation
Time Frame: 2 months
Investigate the presence of hypotonic anal sphincter after anorectal dilatation and HiFU procedure
Secondary Outcomes
No secondary outcomes reported