Clinical trial · Interventional
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)
HERMES Study: A Randomized Clinical Trial To Evaluate Lower Urinary Tract Symptoms Differences Between Indwelling Catheter And Temporary Prostatic Stent In Patients Undergoing Minimally Invasive Procedures For The Treatment Of Localized Prostate Cancer Or Benign Prostatic Hyperplasia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lower Urinary Tract Symptoms | — | UNRESOLVED | — |
| Prostatic Cancer | — | UNRESOLVED | — |
| Prostatic Hyperplasia | Benign Prostatic Hyperplasia | ALIAS | 0.90 |
| Urinary Retention | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indwelling catheter | Device | — | UNRESOLVED |
| Temporary prostatic stent (Exime®) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Temporary prostatic stent (Exime®)
- description
- Post-operative placement of temporary prostatic stent (EXIME)
- interventionNames
- Device: Temporary prostatic stent (Exime®)
- type
- ACTIVE_COMPARATOR
- label
- Indwelling catheter
- description
- Post-operative placement of indwelling catheter
- interventionNames
- Device: Indwelling catheter
Primary outcomes (1)
- measure
- Device-related quality of life
- timeFrame
- 1 week
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Willing and able to provide written informed consent prior to enrollment (if applicable). * Subjects must meet all inclusion criteria to be eligible for study enrollment. * 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. Exclusion Criteria: * 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.
References
Publications (13)
- RESULTDrinka 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
- RESULTToughill 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
- RESULTParsons 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
- RESULTPatelli 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
- RESULTMcVary 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
- RESULTWestwood 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
- RESULTFernandez-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.