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

NCT03289221 | Completed

• 1 other identifier: HIFU02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Anal sphicter evaluation

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

  2 months

Study Arms (1)

Experimental Group

EXPERIMENTAL

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

Interventions

Anal Manometry DIAGNOSTIC_TEST

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.

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hospital de Transplante Doutor Euryclides de Jesus Zerbini: lead

Study Sites (1)

Euryclides de Jesus Zerbini Transplant Hospital

São Paulo, São Paulo, Brazil

Location

Related Publications (18)

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• 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.

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  PMID: 9749478 RESULT

• 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.

  PMID: 8647143 RESULT

• 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.

  PMID: 23415962 RESULT

• 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.

  PMID: 23669165 RESULT

• 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.

  PMID: 26140518 RESULT

• 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.

  PMID: 26597660 RESULT

• 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.

  PMID: 26164416 RESULT

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  PMID: 25692142 RESULT

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Study Officials

• Jose RC Silvino

  Euryclides de Jesus Zerbini Transplant Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 20, 2017
• Study Start: May 1, 2018
• Primary Completion: February 28, 2019
• Study Completion: May 30, 2019
• Last Updated: June 3, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)