<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03289221</url>
  </required_header>
  <id_info>
    <org_study_id>HIFU02</org_study_id>
    <nct_id>NCT03289221</nct_id>
  </id_info>
  <brief_title>Effects of High-Intensity Focused Ultrasound (HIFU) Treatment on Fecal Continence and Anorretal Fisiology</brief_title>
  <official_title>Effects of High-Intensity Focused Ultrasound (HIFU) Treatment on Fecal Continence and Anorretal Fisiology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Transplante Doutor Euryclides de Jesus Zerbini</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Transplante Doutor Euryclides de Jesus Zerbini</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigate the presence of hypotonic anal sphincter after anorectal dilatation and&#xD;
      High-Intensity Focused Ultrasound (HiFU) , through the aplication of questionnaires and&#xD;
      Anorectal Manometry before and after this treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Investigate the presence of hypotonic anal sphincter after anorectal dilatation and&#xD;
      HiFU procedure&#xD;
&#xD;
      Secondary&#xD;
&#xD;
        1. Detect the presence of fecal incontinence&#xD;
&#xD;
        2. Demonstrate the absence of alterations in the fecal pattern&#xD;
&#xD;
        3. Detect alterations in rectal filling sensation and e evacuation desire&#xD;
&#xD;
        4. Evaluate anal pain&#xD;
&#xD;
      PATIENTS AND METHODS Thirty (30) consecutive patients indicated for treatment of prostate&#xD;
      cancer with HIFU (FocalOneR, Edap TMS, France) will be selected. The specific inclusion and&#xD;
      exclusion criteria are specified below. All should present the diagnosis of usual acinar&#xD;
      adenocarcinoma of prostate Gleason score 6 (3 + 3) or Gleason 7 (3 + 4). No patient may have&#xD;
      PSA greater than 10.0. A digital prostate exam should show prostate-restricted disease. The&#xD;
      clinical staging should be ≤ cT2a. There will be no age limit for inclusion. Patients may not&#xD;
      have anatomical, functional or pathological alterations of the anal canal and rectus or&#xD;
      history of anorectal trauma and may not have a diagnosis of psychoneurologic diseases, such&#xD;
      as: Depression, Stroke, Schizophrenia, Degenerative Neurological Diseases or others.&#xD;
&#xD;
      All patients will be submitted to the manometry study the week prior to HIFU together with&#xD;
      the application of specific questionnaires (Cleveland Clinic Incontinence Score-CCIS, Fecal&#xD;
      Incontinence Quality of Life Score-FIQLS, and Rome IV for functional constipation. This&#xD;
      examination will be conducted in a friendly environment and by experienced professionals.&#xD;
&#xD;
      Patients who met the inclusion and exclusion criteria and who signed the informed consent&#xD;
      form will be linked to the study.&#xD;
&#xD;
      REALIZATION OF HIFU, MANOMETRY AND QUESTIONNAIRES All patients treated with HIFU should have&#xD;
      prostate volume less than 40g for treatment of hemigland or 30g for whole gland treatments.&#xD;
      Patients will have rectal cleansing for 3 to 6 hours prior to the procedure and will be&#xD;
      treated according to the FocalOneR treatment protocol, with general anesthesia and bladder&#xD;
      catheterization with Foley 16 or 18 Fr catheter. After general anesthesia and positioning,&#xD;
      digital dilatation of the anal sphincter and introduction of the HIFU probe will be&#xD;
      performed. With the end of treatment, the probe is withdrawn, and the patient awake from the&#xD;
      anesthesia. In the anesthetic recovery room will be applied the visual pain scale that will&#xD;
      also be applied at the time of hospital discharge and on the thirtieth day of the procedure.&#xD;
      Patients may receive common analgesics as needed.&#xD;
&#xD;
      To perform the manometry examination it is necessary that the patient is awake, without&#xD;
      effect of sedatives and cooperating with examination. A suppository will be used to clean the&#xD;
      rectum 3 to 4 hours prior to the examination. And the pressures of rest and voluntary&#xD;
      contraction of the anal sphincter will be evaluated, as well as the behavior of the pubortal&#xD;
      muscle during the evacuation maneuver. Retinal inhibitory reflex (RIRA), sensitivity and&#xD;
      rectal capacity will also be evaluated.&#xD;
&#xD;
      Questionnaires that evaluate the pre and post HIFU anal physiology will also be applied at&#xD;
      the time of manometry.&#xD;
&#xD;
      PLACE OF ACHIEVEMENT OF RESEARCH AND FINANCIAL RESOURCES The selected patients will perform&#xD;
      the tests of manometry, the HIFU procedure, the follow-up and treatment of possible&#xD;
      complications in the Hospital of Transplants Euryclides de Jesus Zerbini (Hospital&#xD;
      Brigadeiro) through the Unique Health System (UHS/SUS). This research does not have any&#xD;
      private financial support. The funds will come from the SUS and there will be no excess&#xD;
      expenses to the SUS.&#xD;
&#xD;
      THE SAMPLE AND TIME OF RECRUITMENT Thirty (30) consecutive patients will be selected, with&#xD;
      indication of treatment of malignant neoplasm of the prostate by the HIFU method, and that&#xD;
      they respect the criteria of inclusion and exclusion. The estimated time for recruitment of&#xD;
      the completed sample is 30 days. And the deadline for the entire study will be 60 days from&#xD;
      the start of the study.&#xD;
&#xD;
      STATISTIC Statistical analysis will be performed with the help of SPSS 17.0 for Windows.&#xD;
      Results such as mean, median and prevalence will be calculated. The significance level&#xD;
      adopted will be 0.05.&#xD;
&#xD;
      COSTS All manometry examinations will be performed at the Paulista Endoscopy Center (CPE -&#xD;
      CNPJ: 48.109.011 / 0001-30). The CPE will make available all the physical structure,&#xD;
      employees, trained doctors and materials needed to perform the manometry exams. Patients will&#xD;
      be asked to attend CPE (Rua Cincinato Braga, 37, CJ. 12, 1st floor, Bela Vista, SP) and NO&#xD;
      COST TO THE BRIGADEIRO HOSPITAL, FOR PATIENTS AND / OR RESEARCHERS.&#xD;
&#xD;
      RISK ANALYSIS, PROTECTION MEASURES AND SUSPENSION OF RESEARCH This research does not involve&#xD;
      any experimental procedure. The treatment of patients with HIFU is already established with&#xD;
      specific cancer survival results found in the literature for 10 years (7, 8).&#xD;
&#xD;
      The manometry exam is a very safe technique and practically free of complications. In very&#xD;
      rare cases, small rectal bleeding of spontaneous resolution, low intensity pain in the anal&#xD;
      region, and very rarely, perforation of the rectal mucosa may occur with the need for&#xD;
      surgery. (19) In any case, the presence of complications will be treated at the Brigadeiro&#xD;
      Hospital, which has urologists 24 hours a day, 7 days a week. In addition, the Brigadeiro&#xD;
      Hospital has emergency room for patients 24/7 with clinicians on call and support general&#xD;
      surgery staff. The patients will be instructed to return immediately to the Hospital in case&#xD;
      of any complications, where they will be attended by a doctor of the urology team and&#xD;
      communicated the occurrence to the researchers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Actual">May 30, 2019</completion_date>
  <primary_completion_date type="Actual">February 28, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>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_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anal sphicter evaluation</measure>
    <time_frame>2 months</time_frame>
    <description>Investigate the presence of hypotonic anal sphincter after anorectal dilatation and HiFU procedure</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Anal Continence After High-Intensity Focused Ultrasound (HIFU) Treatment</condition>
  <arm_group>
    <arm_group_label>Experimental Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Anal Manometry</intervention_name>
    <description>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.&#xD;
Questionnaires that evaluate the pre and post HIFU anal physiology will also be applied at the time of manometry.</description>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients of any age with diagnosis of usual acinar adenocarcinoma of the prostate;&#xD;
&#xD;
          2. Patients that treatment with HIFU is an option;&#xD;
&#xD;
          3. And, that they accept to undergo the pre-and post-HIFU anorectal manometry;&#xD;
&#xD;
          4. And, answer the questionnaires applied;&#xD;
&#xD;
          5. And, signature of the informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who have no indication of HIFU treatment;&#xD;
&#xD;
          2. Or, who have already undergone some anorectal surgery;&#xD;
&#xD;
          3. Or, that they present some psychoneurological disease;&#xD;
&#xD;
          4. Or, who have anatomical, functional or pathological alterations of the rectum or anal;&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jose RC Silvino</last_name>
    <role>Principal Investigator</role>
    <affiliation>Euryclides de Jesus Zerbini Transplant Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Euryclides de Jesus Zerbini Transplant Hospital</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <results_reference>
    <citation>Crawford ED. Epidemiology of prostate cancer. Urology. 2003 Dec 22;62(6 Suppl 1):3-12. doi: 10.1016/j.urology.2003.10.013.</citation>
    <PMID>14706503</PMID>
  </results_reference>
  <results_reference>
    <citation>Carter HB, Pearson JD. Prostate-specific antigen testing for early diagnosis of prostate cancer: formulation of guidelines. Urology. 1999 Nov;54(5):780-6. doi: 10.1016/s0090-4295(99)00271-x. No abstract available.</citation>
    <PMID>10565733</PMID>
  </results_reference>
  <results_reference>
    <citation>Jemal A, Ward EM, Johnson CJ, Cronin KA, Ma J, Ryerson B, Mariotto A, Lake AJ, Wilson R, Sherman RL, Anderson RN, Henley SJ, Kohler BA, Penberthy L, Feuer EJ, Weir HK. Annual Report to the Nation on the Status of Cancer, 1975-2014, Featuring Survival. J Natl Cancer Inst. 2017 Sep 1;109(9):djx030. doi: 10.1093/jnci/djx030.</citation>
    <PMID>28376154</PMID>
  </results_reference>
  <results_reference>
    <citation>D'Amico AV, Whittington R, Malkowicz SB, Schultz D, Blank K, Broderick GA, Tomaszewski JE, Renshaw AA, Kaplan I, Beard CJ, Wein A. Biochemical outcome after radical prostatectomy, external beam radiation therapy, or interstitial radiation therapy for clinically localized prostate cancer. JAMA. 1998 Sep 16;280(11):969-74. doi: 10.1001/jama.280.11.969.</citation>
    <PMID>9749478</PMID>
  </results_reference>
  <results_reference>
    <citation>Gelet A, Chapelon JY, Bouvier R, Souchon R, Pangaud C, Abdelrahim AF, Cathignol D, Dubernard JM. Treatment of prostate cancer with transrectal focused ultrasound: early clinical experience. Eur Urol. 1996;29(2):174-83.</citation>
    <PMID>8647143</PMID>
  </results_reference>
  <results_reference>
    <citation>Thuroff S, Chaussy C. Evolution and outcomes of 3 MHz high intensity focused ultrasound therapy for localized prostate cancer during 15 years. J Urol. 2013 Aug;190(2):702-10. doi: 10.1016/j.juro.2013.02.010. Epub 2013 Feb 13.</citation>
    <PMID>23415962</PMID>
  </results_reference>
  <results_reference>
    <citation>Crouzet S, Chapelon JY, Rouviere O, Mege-Lechevallier F, Colombel M, Tonoli-Catez H, Martin X, Gelet A. Whole-gland ablation of localized prostate cancer with high-intensity focused ultrasound: oncologic outcomes and morbidity in 1002 patients. Eur Urol. 2014 May;65(5):907-14. doi: 10.1016/j.eururo.2013.04.039. Epub 2013 Apr 30.</citation>
    <PMID>23669165</PMID>
  </results_reference>
  <results_reference>
    <citation>Ramsay CR, Adewuyi TE, Gray J, Hislop J, Shirley MD, Jayakody S, MacLennan G, Fraser C, MacLennan S, Brazzelli M, N'Dow J, Pickard R, Robertson C, Rothnie K, Rushton SP, Vale L, Lam TB. Ablative therapy for people with localised prostate cancer: a systematic review and economic evaluation. Health Technol Assess. 2015 Jul;19(49):1-490. doi: 10.3310/hta19490.</citation>
    <PMID>26140518</PMID>
  </results_reference>
  <results_reference>
    <citation>van Velthoven R, Aoun F, Marcelis Q, Albisinni S, Zanaty M, Lemort M, Peltier A, Limani K. A prospective clinical trial of HIFU hemiablation for clinically localized prostate cancer. Prostate Cancer Prostatic Dis. 2016 Mar;19(1):79-83. doi: 10.1038/pcan.2015.55. Epub 2015 Nov 24.</citation>
    <PMID>26597660</PMID>
  </results_reference>
  <results_reference>
    <citation>Feijoo ER, Sivaraman A, Barret E, Sanchez-Salas R, Galiano M, Rozet F, Prapotnich D, Cathala N, Mombet A, Cathelineau X. Focal High-intensity Focused Ultrasound Targeted Hemiablation for Unilateral Prostate Cancer: A Prospective Evaluation of Oncologic and Functional Outcomes. Eur Urol. 2016 Feb;69(2):214-20. doi: 10.1016/j.eururo.2015.06.018. Epub 2015 Jul 9.</citation>
    <PMID>26164416</PMID>
  </results_reference>
  <results_reference>
    <citation>Peltier A, Aoun F, Lemort M, Kwizera F, Paesmans M, Van Velthoven R. MRI-targeted biopsies versus systematic transrectal ultrasound guided biopsies for the diagnosis of localized prostate cancer in biopsy naive men. Biomed Res Int. 2015;2015:571708. doi: 10.1155/2015/571708. Epub 2015 Jan 27.</citation>
    <PMID>25692142</PMID>
  </results_reference>
  <results_reference>
    <citation>Perry RE, Blatchford GJ, Christensen MA, Thorson AG, Attwood SE. Manometric diagnosis of anal sphincter injuries. Am J Surg. 1990 Jan;159(1):112-6; discussion 116-7. doi: 10.1016/s0002-9610(05)80615-4.</citation>
    <PMID>2294787</PMID>
  </results_reference>
  <results_reference>
    <citation>Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. doi: 10.1007/BF02050307.</citation>
    <PMID>8416784</PMID>
  </results_reference>
  <results_reference>
    <citation>Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000 Jan;43(1):9-16; discussion 16-7. doi: 10.1007/BF02237236.</citation>
    <PMID>10813117</PMID>
  </results_reference>
  <results_reference>
    <citation>Williams N, Barlow J, Hobson A, Scott N, Irving M. Manometric asymmetry in the anal canal in controls and patients with fecal incontinence. Dis Colon Rectum. 1995 Dec;38(12):1275-80. doi: 10.1007/BF02049152.</citation>
    <PMID>7497839</PMID>
  </results_reference>
  <results_reference>
    <citation>Taylor BM, Beart RW Jr, Phillips SF. Longitudinal and radial variations of pressure in the human anal sphincter. Gastroenterology. 1984 Apr;86(4):693-7.</citation>
    <PMID>6698369</PMID>
  </results_reference>
  <results_reference>
    <citation>Nelson R, Norton N, Cautley E, Furner S. Community-based prevalence of anal incontinence. JAMA. 1995 Aug 16;274(7):559-61.</citation>
    <PMID>7629985</PMID>
  </results_reference>
  <results_reference>
    <citation>Jorge JM, Wexner SD. Anorectal manometry: techniques and clinical applications. South Med J. 1993 Aug;86(8):924-31. doi: 10.1097/00007611-199308000-00016.</citation>
    <PMID>8351556</PMID>
  </results_reference>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>May 30, 2019</last_update_submitted>
  <last_update_submitted_qc>May 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03289221
org study id: HIFU02
nct id: NCT03289221
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: 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.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Anal sphicter evaluation
time frame: 2 months
description: Investigate the presence of hypotonic anal sphincter after anorectal dilatation and HiFU procedure
arm group label: Experimental Group
arm group type: Experimental
description: 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 type: Diagnostic Test
intervention name: Anal Manometry
description: 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.
arm group label: Experimental Group
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jose RC Silvino
role: Principal Investigator
affiliation: Euryclides de Jesus Zerbini Transplant Hospital
facility: 
country: Brazil
citation: Crawford ED. Epidemiology of prostate cancer. Urology. 2003 Dec 22;62(6 Suppl 1):3-12. doi: 10.1016/j.urology.2003.10.013.
PMID: 14706503
citation: Carter HB, Pearson JD. Prostate-specific antigen testing for early diagnosis of prostate cancer: formulation of guidelines. Urology. 1999 Nov;54(5):780-6. doi: 10.1016/s0090-4295(99)00271-x. No abstract available.
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