Effects of High-Intensity Focused Ultrasound (HIFU) Treatment on Fecal Continence and Anorretal Fisiology

May 30, 2019 updated by: Hospital de Transplante Doutor Euryclides de Jesus Zerbini
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary Investigate the presence of hypotonic anal sphincter after anorectal dilatation and HiFU procedure

Secondary

  1. Detect the presence of fecal incontinence
  2. Demonstrate the absence of alterations in the fecal pattern
  3. Detect alterations in rectal filling sensation and e evacuation desire
  4. 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.

Patients who met the inclusion and exclusion criteria and who signed the informed consent form will be linked to the study.

REALIZATION OF HIFU, MANOMETRY AND QUESTIONNAIRES All patients treated with HIFU should have prostate volume less than 40g for treatment of hemigland or 30g for whole gland treatments. Patients will have rectal cleansing for 3 to 6 hours prior to the procedure and will be treated according to the FocalOneR treatment protocol, with general anesthesia and bladder catheterization with Foley 16 or 18 Fr catheter. After general anesthesia and positioning, digital dilatation of the anal sphincter and introduction of the HIFU probe will be performed. With the end of treatment, the probe is withdrawn, and the patient awake from the anesthesia. In the anesthetic recovery room will be applied the visual pain scale that will also be applied at the time of hospital discharge and on the thirtieth day of the procedure. Patients may receive common analgesics as needed.

To perform the manometry examination it is necessary that the patient is awake, without effect of sedatives and cooperating with examination. A suppository will be used to clean the rectum 3 to 4 hours prior to the examination. And the pressures of rest and voluntary contraction of the anal sphincter will be evaluated, as well as the behavior of the pubortal muscle during the evacuation maneuver. Retinal inhibitory reflex (RIRA), sensitivity and rectal capacity will also be evaluated.

Questionnaires that evaluate the pre and post HIFU anal physiology will also be applied at the time of manometry.

PLACE OF ACHIEVEMENT OF RESEARCH AND FINANCIAL RESOURCES The selected patients will perform the tests of manometry, the HIFU procedure, the follow-up and treatment of possible complications in the Hospital of Transplants Euryclides de Jesus Zerbini (Hospital Brigadeiro) through the Unique Health System (UHS/SUS). This research does not have any private financial support. The funds will come from the SUS and there will be no excess expenses to the SUS.

THE SAMPLE AND TIME OF RECRUITMENT Thirty (30) consecutive patients will be selected, with indication of treatment of malignant neoplasm of the prostate by the HIFU method, and that they respect the criteria of inclusion and exclusion. The estimated time for recruitment of the completed sample is 30 days. And the deadline for the entire study will be 60 days from the start of the study.

STATISTIC Statistical analysis will be performed with the help of SPSS 17.0 for Windows. Results such as mean, median and prevalence will be calculated. The significance level adopted will be 0.05.

COSTS All manometry examinations will be performed at the Paulista Endoscopy Center (CPE - CNPJ: 48.109.011 / 0001-30). The CPE will make available all the physical structure, employees, trained doctors and materials needed to perform the manometry exams. Patients will be asked to attend CPE (Rua Cincinato Braga, 37, CJ. 12, 1st floor, Bela Vista, SP) and NO COST TO THE BRIGADEIRO HOSPITAL, FOR PATIENTS AND / OR RESEARCHERS.

RISK ANALYSIS, PROTECTION MEASURES AND SUSPENSION OF RESEARCH This research does not involve any experimental procedure. The treatment of patients with HIFU is already established with specific cancer survival results found in the literature for 10 years (7, 8).

The manometry exam is a very safe technique and practically free of complications. In very rare cases, small rectal bleeding of spontaneous resolution, low intensity pain in the anal region, and very rarely, perforation of the rectal mucosa may occur with the need for surgery. (19) In any case, the presence of complications will be treated at the Brigadeiro Hospital, which has urologists 24 hours a day, 7 days a week. In addition, the Brigadeiro Hospital has emergency room for patients 24/7 with clinicians on call and support general surgery staff. The patients will be instructed to return immediately to the Hospital in case of any complications, where they will be attended by a doctor of the urology team and communicated the occurrence to the researchers.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil
        • Euryclides de Jesus Zerbini Transplant Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Patients of any age with diagnosis of usual acinar adenocarcinoma of the prostate;
  2. Patients that treatment with HIFU is an option;
  3. And, that they accept to undergo the pre-and post-HIFU anorectal manometry;
  4. And, answer the questionnaires applied;
  5. And, signature of the informed consent form.

Exclusion Criteria:

  1. Patients who have no indication of HIFU treatment;
  2. Or, who have already undergone some anorectal surgery;
  3. Or, that they present some psychoneurological disease;
  4. Or, who have anatomical, functional or pathological alterations of the rectum or anal;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Diagnostic test: Anal Manometry

A suppository will be used to clean the rectum 3 to 4 hours prior to the examination. And the pressures of rest and voluntary contraction of the anal sphincter will be evaluated, as well as the behavior of the pubortal muscle during the evacuation maneuver. Retinal inhibitory reflex (RIRA), sensitivity and rectal capacity will also be evaluated.

Questionnaires that evaluate the pre and post HIFU anal physiology will also be applied at the time of manometry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anal sphicter evaluation
Time Frame: 2 months
Investigate the presence of hypotonic anal sphincter after anorectal dilatation and HiFU procedure
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Transplante Doutor Euryclides de Jesus Zerbini

Investigators

  • Principal Investigator: Jose RC Silvino, Euryclides de Jesus Zerbini Transplant Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Actual)

February 28, 2019

Study Completion (Actual)

May 30, 2019

Study Registration Dates

First Submitted

September 18, 2017

First Submitted That Met QC Criteria

September 19, 2017

First Posted (Actual)

September 20, 2017

Study Record Updates

Last Update Posted (Actual)

June 3, 2019

Last Update Submitted That Met QC Criteria

May 30, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • HIFU02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anal Continence After High-Intensity Focused Ultrasound (HIFU) Treatment

Clinical Trials on Anal Manometry

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe