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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 EchoLaserâ„¢ system for the treatment of benign prostatic hyperplasia (BPH)
The main questions are:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Temporary prostatic stent (Exime®) | Experimental | Post-operative placement of temporary prostatic stent (EXIME) |
|
| Indwelling catheter | Active Comparator | Post-operative placement of indwelling catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temporary prostatic stent (Exime®) | Device | Placement of temporary prostatic stent (Exime®) following the procedure described in the product information |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Device-related urinary side effects | Evaluation will be based on the first five questions (Q1 - Q5) of a non validated questionnaire with quantitative answers ranging from 0 to 10, defined as: Q1:How much urine leakage have you had while carrying the bladder catheter or the Exime® device? (0: none -> 10 a lot of leakage = need to use several diapers) Q2. How much pain, discomfort or spasms have you had in relation to the catheter/Exime®? (0: none -> 10: a lot of pain = need for prescribed analgesia) Q3. How much bleeding have you had with urine while wearing the catheter/Exime®? (0: none -> 10: a lot of bleeding = need for change of clothing) Q4. How much has the urine been different? (darker than usual, worse odor, or sediment)? (0: nothing -> 10: very strong odor, very dark urine, presence of lumps) Q5. Have you had any problems in handling the catheter? (0: no problems at all -> 10: many problems) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan I Martinez-Salamanca, MD PhD FEBU FACS FEBSM | Contact | +34620255030 | jims@lyxurologia.com |
| Name | Affiliation | Role |
|---|---|---|
| Juan I Martinez-Salamanca, MD PhD FEBU FACS FEBSM | Lyx Institute UrologÃa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Juan Ignacio Martinez-Salamanca | Madrid | 28006 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16843240 | Result | 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. | |
| 15867530 | 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. |
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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.
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| Indwelling catheter | Device | Placement of indwelling catheter |
|
| 1 week |
| Device-related patient satisfaction | Evaluation of satisfaction of patients associated with the device will be based on the seventh question (Q7) of a non validated questionnaire (Stent/catheter-related urinary symptoms questionnaire), defined as: Q7. What is your degree of satisfaction while wearing the catheter/Exime®? Quantitative answer, ranging from 0 to 10. Being zero, not satisfied at all; and being ten, completely satisfied | 1 week |
| Device-related Lower Urinary Tract Symptoms (LUTS) | Evaluation of impact of the device on LUTS will be based on a validated questionnaire administered before the device-placement, at device-removal, at 4 weeks and finally at 6 months after treatment: - International Prostate Symptom Score (IPSS), min 0 - max 35 points, in which higher values are associated with worsening urinary symptoms | From device-placement to 6 months after treatment |
| Occurence of perioperative events (< or = 24h after treatment) | Evaluation of perioperative events (< or = 24h after treatment) defined as complications (classified according to the Clavien - Dindo scale), presence of haematuria, pain (based on visual analogue pain score), occurence of acute urinary retention or need to perform urinary catheter bladder washout. | 1 post-operative day |
| Occurrence of postoperative events (>24h-1week) | Evaluation of postoperative events (>24h-1week) defined as acute urinary retention or need to perform urinary catheter bladder washout, need to change urinary catheter or presence of urinary tract infection (presence of fever or need to change antibiotic therapy) and others complications (classified according to the Clavien - Dindo scale) | 1 week |
| Overall satisfaction outcomes | Evaluation of overall satisfaction will be based on the question "How satisfied are you overall with the treatment you have received? (Quantitative answer, ranging from 0 to 10. Being zero, not satisfied at all; and being ten, completely satisfied) administered at 4 week post-treatment. | 4 week |
| Urine flow rate | Maximal flow rate [Q max (ml/s)] will be evaluated performing a uroflowmetry at baseline, at week 4, and finally at 6 months after treatment. | From device-placement to 6 months after treatment |
| Device-related continence symptoms | Evaluation of impact of the device on continence symptoms will be based on a validated questionnaire administered before the device-placement, at device-removal, at 4 weeks and finally at 6 months after treatment: - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF): min 0 - max 21 points, the higher the score, the more severe is the urinary incontinence, but there is no normal score. | From device-placement to 6 months after treatment |
| 21475707 | 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. |
| 28474112 | 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. |
| 30677455 | 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. |
| 30344644 | 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. |
| 35570100 | 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. |
| 28780635 | 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. |
| 30631433 | 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. |
| 15227649 | 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. |
| 32532513 | 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. |
| 30638633 | 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. |
| 17936815 | 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. |
| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| D011470 | Prostatic Hyperplasia |
| D011471 | Prostatic Neoplasms |
| D016055 | Urinary Retention |
| ID | Term |
|---|---|
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D002408 | Catheters, Indwelling |
| ID | Term |
|---|---|
| D057785 | Catheters |
| D004864 | Equipment and Supplies |
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