To Evaluate LUTS and Complications Between Indwelling Catheter and Temporary Prostatic Stent in Patients Undergoing Minimally Invasive Procedures for the Treatment of Localized Prostate Cancer or Benign Prostatic Hyperplasia (HERMES)

NCT05851521 | Unknown

• 1 other identifier: HERMES01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this single-centre prospective randomized clinical trial is to compare the post-operative use of temporary prostatic stent (Group 1) vs indwelling catheter (Group 2) in patients undergoing cryotherapy for targeted therapy of localized prostate cancer, transurethral water vapor energy ablation (REZUM) or transperineal laser ablation of the prostate with EchoLaser™ system for the treatment of benign prostatic hyperplasia (BPH) The main questions are:

• Difference in quality of life, Lower Urinary Tract Symptoms (scored with IPSS, International Prostate Symptom Score), urinary continence symptoms (scored with International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form, ICIQ-UI-SF) and patient satisfaction between indwelling catheter and temporary prostatic stent (Exime®) score with a non-validated questionnaire (Stent/catheter-related urinary symptoms questionnaire)
• Difference in side effects and complications between indwelling catheter and temporary prostatic stent (Exime®) A total 120 of patients will be enrolled (Group 1: 60; Group 2: 60) with a 1:1 randomization ratio. The follow-up duration will be 6 months.

Conditions

Lower Urinary Tract Symptoms; Prostatic Hyperplasia; Prostatic Cancer; Urinary Retention

Keywords

Temporary prostatic stent; Indwelling catheter; Cryotherapy; Prostate cancer; Benign prostatic hyperplasia; Rezum; EchoLaser

Outcome Measures

Primary Outcomes (1)

• Device-related quality of life

  Evaluation of impact on patient quality of life associated with the urinary device will be based on the sixth question (Q6) of a non validated questionnaire (Stent/catheter-related urinary symptoms questionnaire), defined as: Q6: "How much has the bladder catheter/Exime affected your quality of life?" Quantitative answer, ranging from 0 to 10. Being zero, not affected; and being ten, very affected

  1 week

Secondary Outcomes (8)

• Device-related urinary side effects

  1 week

• Device-related patient satisfaction

  1 week

• Device-related Lower Urinary Tract Symptoms (LUTS)

  From device-placement to 6 months after treatment

• Occurence of perioperative events (< or = 24h after treatment)

  1 post-operative day

• Occurrence of postoperative events (>24h-1week)

  1 week

Study Arms (2)

Temporary prostatic stent (Exime®)

EXPERIMENTAL

Post-operative placement of temporary prostatic stent (EXIME)

Device: Temporary prostatic stent (Exime®)

Indwelling catheter

ACTIVE COMPARATOR

Post-operative placement of indwelling catheter

Device: Indwelling catheter

Interventions

Temporary prostatic stent (Exime®) DEVICE

Placement of temporary prostatic stent (Exime®) following the procedure described in the product information

Temporary prostatic stent (Exime®)

Indwelling catheter DEVICE

Placement of indwelling catheter

Indwelling catheter

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide written informed consent prior to enrollment (if applicable).
• Men between 18 and 85 years old.
• Undergo focal therapy for prostate cancer, water vapour energy ablation Rezum® or EchoLaser®.
• Willing to be seen by the investigator and answer questions and fill out questionnaires up to a month after surgery.

You may not qualify if:

• Urethral stricture \<22F.
• Gross haematuria
• Prostate volume \> 80cc
• Prostate craniocaudal length \> 6cm
• Patients with long-term urinary catheters or other urinary drainage systems
• Lack of commitment on the part of the patient to attend the follow-up as required.

Sponsors & Collaborators

• Lyx Institute: lead

Study Sites (1)

Juan Ignacio Martinez-Salamanca

Madrid, 28006, Spain

Location

Related Publications (13)

• Drinka PJ. Complications of chronic indwelling urinary catheters. J Am Med Dir Assoc. 2006 Jul;7(6):388-92. doi: 10.1016/j.jamda.2006.01.020. Epub 2006 Mar 23.

  PMID: 16843240 RESULT

• Toughill E. Indwelling urinary catheters: common mechanical and pathogenic problems. Am J Nurs. 2005 May;105(5):35-7. doi: 10.1097/00000446-200505000-00025. No abstract available.

  PMID: 15867530 RESULT

• Parsons JK. Benign Prostatic Hyperplasia and Male Lower Urinary Tract Symptoms: Epidemiology and Risk Factors. Curr Bladder Dysfunct Rep. 2010 Dec;5(4):212-218. doi: 10.1007/s11884-010-0067-2. Epub 2010 Sep 7.

  PMID: 21475707 RESULT

• Patelli G, Ranieri A, Paganelli A, Mauri G, Pacella CM. Transperineal Laser Ablation for Percutaneous Treatment of Benign Prostatic Hyperplasia: A Feasibility Study. Cardiovasc Intervent Radiol. 2017 Sep;40(9):1440-1446. doi: 10.1007/s00270-017-1662-9. Epub 2017 May 4.

  PMID: 28474112 RESULT

• McVary KT, Rogers T, Roehrborn CG. Rezum Water Vapor Thermal Therapy for Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: 4-Year Results From Randomized Controlled Study. Urology. 2019 Apr;126:171-179. doi: 10.1016/j.urology.2018.12.041. Epub 2019 Jan 21.

  PMID: 30677455 RESULT

• Westwood J, Geraghty R, Jones P, Rai BP, Somani BK. Rezum: a new transurethral water vapour therapy for benign prostatic hyperplasia. Ther Adv Urol. 2018 Aug 12;10(11):327-333. doi: 10.1177/1756287218793084. eCollection 2018 Nov.

  PMID: 30344644 RESULT

• Fernandez-Guzman E, Asensio Matas A, Capape Poves V, Rioja Zuazu J, Garrido Abad P, Martinez-Salamanca JI, Quintana Franco LM, Justo-Quintas J, Romero-Otero J, Dominguez-Esteban M. Preliminary results of a national multicenter study on the treatment of LUTS secondary to benign prostatic hyperplasia using the Rezum(R) steam system. Actas Urol Esp (Engl Ed). 2022 Jun;46(5):310-316. doi: 10.1016/j.acuroe.2021.11.003. Epub 2022 May 12. English, Spanish.

  PMID: 35570100 RESULT

• Helo S, Holland B, McVary KT. Convective Radiofrequency Water Vapor Thermal Therapy with Rezum System. Curr Urol Rep. 2017 Oct;18(10):78. doi: 10.1007/s11934-017-0728-1.

  PMID: 28780635 RESULT

• Guelce D, Thomas D, Elterman D, Chughtai B. Recent advances in managing benign prostatic hyperplasia: The Rezum System. F1000Res. 2018 Dec 10;7:F1000 Faculty Rev-1916. doi: 10.12688/f1000research.15851.1. eCollection 2018.

  PMID: 30631433 RESULT

• Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn. 2004;23(4):322-30. doi: 10.1002/nau.20041.

  PMID: 15227649 RESULT

• Lebastchi AH, George AK, Polascik TJ, Coleman J, de la Rosette J, Turkbey B, Wood BJ, Gorin MA, Sidana A, Ghai S, Tay KJ, Ward JF, Sanchez-Salas R, Muller BG, Malavaud B, Mozer P, Crouzet S, Choyke PL, Ukimura O, Rastinehad AR, Pinto PA. Standardized Nomenclature and Surveillance Methodologies After Focal Therapy and Partial Gland Ablation for Localized Prostate Cancer: An International Multidisciplinary Consensus. Eur Urol. 2020 Sep;78(3):371-378. doi: 10.1016/j.eururo.2020.05.018. Epub 2020 Jun 10.

  PMID: 32532513 RESULT

• Shah TT, Peters M, Eldred-Evans D, Miah S, Yap T, Faure-Walker NA, Hosking-Jervis F, Thomas B, Dudderidge T, Hindley RG, McCracken S, Greene D, Nigam R, Valerio M, Minhas S, Winkler M, Arya M, Ahmed HU. Early-Medium-Term Outcomes of Primary Focal Cryotherapy to Treat Nonmetastatic Clinically Significant Prostate Cancer from a Prospective Multicentre Registry. Eur Urol. 2019 Jul;76(1):98-105. doi: 10.1016/j.eururo.2018.12.030. Epub 2019 Jan 9.

  PMID: 30638633 RESULT

• Eggener SE, Scardino PT, Carroll PR, Zelefsky MJ, Sartor O, Hricak H, Wheeler TM, Fine SW, Trachtenberg J, Rubin MA, Ohori M, Kuroiwa K, Rossignol M, Abenhaim L; International Task Force on Prostate Cancer and the Focal Lesion Paradigm. Focal therapy for localized prostate cancer: a critical appraisal of rationale and modalities. J Urol. 2007 Dec;178(6):2260-7. doi: 10.1016/j.juro.2007.08.072. Epub 2007 Oct 15.

  PMID: 17936815 RESULT

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Prostatic Hyperplasia; Prostatic Neoplasms; Urinary Retention

Interventions

Catheters, Indwelling

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies

Study Officials

• Juan I Martinez-Salamanca, MD PhD FEBU FACS FEBSM

  Lyx Institute Urología

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan I Martinez-Salamanca, MD PhD FEBU FACS FEBSM

CONTACT

+34620255030; jims@lyxurologia.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective randomized clinical trial divided in 3 cohorts: HERMES\_CRYO (cryotherapy for targeted therapy of localized prostate cancer), HERMES\_REZUM \[water vapor energy ablation for the treatment of benign prostatic hyperplasia (BPH)\], and HERMES\_LASER \[ELESTA ECHOLASER® for the treatment of benign prostatic hyperplasia (BPH)\]. In each cohort, two arms will be compared: temporary prostatic stent vs indwelling catheter with a 1:1 randomization ratio.

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: May 9, 2023
• Study Start: June 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: May 9, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)