Lower Urinary Tract SymptomsHERMESNCT05851521
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)
A study testing Temporary prostatic stent (Exime®) and Indwelling catheter in people with Lower Urinary Tract Symptoms and Prostatic Hyperplasia, run by Lyx Institute at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Lower Urinary Tract Symptoms, Prostatic Hyperplasia, Prostatic Cancer
- What is being tested?
- Temporary prostatic stent (Exime®) and Indwelling catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2023to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Juan Ignacio Martinez-Salamanca
Madrid, 28006
Juan I Martínez-Salamanca, MD, +34620255030, jims@lyxurologia.com
About this study
Official title: 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
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:
Read more
- 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.
- Being tested
- Temporary prostatic stent (Exime®), Indwelling catheter
- Keywords
- Temporary prostatic stent, Indwelling catheter, Cryotherapy, Prostate cancer, Benign prostatic hyperplasia, Rezum, EchoLaser
- Medical subject headings
- Lower Urinary Tract Symptoms, Prostatic Hyperplasia, Prostatic Neoplasms, Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary prostatic stent (Exime®)Device
Placement of temporary prostatic stent (Exime®) following the procedure described in the product information
Indwelling catheterDevice
Placement of indwelling catheter
| Study group | Role | What they receive |
|---|---|---|
| Temporary prostatic stent (Exime®) | Experimental | Post-operative placement of temporary prostatic stent (EXIME) Receives: Device: Temporary prostatic stent (Exime®) |
| Indwelling catheter | Active comparator | Post-operative placement of indwelling catheter Receives: Device: Indwelling catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 week
Secondary outcomes (8)
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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From device-placement to 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study startJun 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lyx Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan I Martinez-Salamanca, MD PhD FEBU FACS FEBSM, Principal investigator, Lyx Institute Urología
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851521
- Sponsor's protocol ID
- HERMES01
- Acronym
- HERMES
- Status last verified
- Apr 2023
- First submitted
- 22 Mar 2023
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16843240Toughill 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.
PubMed 15867530Parsons 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.
PubMed 21475707Patelli 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.
PubMed 28474112McVary 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.
PubMed 30677455Westwood 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.
PubMed 30344644Fernandez-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.
PubMed 35570100Helo 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.
PubMed 28780635Guelce 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.
PubMed 30631433Avery 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.
PubMed 15227649Lebastchi 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.
PubMed 32532513Shah 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.
PubMed 30638633Eggener 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.
PubMed 17936815
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05851521
- Acronym / sponsor ID
- HERMES / HERMES01
- Keywords
- Temporary prostatic stent, Indwelling catheter, Cryotherapy, Prostate cancer, Benign prostatic hyperplasia, Rezum, EchoLaser
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Lyx InstituteUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Temporary prostatic stent (Exime®) | Experimental | Device: Temporary prostatic stent (Exime®)Post-operative placement of temporary prostatic stent (EXIME) |
| Indwelling catheter | Active comparator | Device: Indwelling catheterPost-operative placement of indwelling catheter |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- Urethral stricture <22F.
- Gross haematuria
- Prostate volume > 80cc
- Prostate craniocaudal length > 6cm
- Patients with long-term urinary catheters or other urinary drainage systems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temporary prostatic stent (Exime®)Placement of temporary prostatic stent (Exime®) following the procedure described in the product information | Device | Temporary prostatic stent (Exime®) |
| Indwelling catheterPlacement of indwelling catheter | Device | Indwelling catheter |
Primary outcome
Device-related quality of life
Time frame: 1 week
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
8 secondary outcomes
Device-related urinary side effects
Time frame: 1 week
Device-related patient satisfaction
Time frame: 1 week
Device-related Lower Urinary Tract Symptoms (LUTS)
Time frame: From device-placement to 6 months after treatment
Occurence of perioperative events (< or = 24h after treatment)
Time frame: 1 post-operative day
Occurrence of postoperative events (>24h-1week)
Time frame: 1 week
Overall satisfaction outcomes
Time frame: 4 week
Urine flow rate
Time frame: From device-placement to 6 months after treatment
Device-related continence symptoms
Time frame: From device-placement to 6 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Results publication: PubMed 16843240Drinka 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.
- Results publication: PubMed 15867530Toughill 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.
- Results publication: PubMed 21475707Parsons 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.
- Results publication: PubMed 28474112Patelli 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.
- Results publication: PubMed 30677455McVary 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.
- Results publication: PubMed 30344644Westwood 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.
- Results publication: PubMed 35570100Fernandez-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.
- Results publication: PubMed 28780635Helo 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.
- Results publication: PubMed 30631433Guelce 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.
- Results publication: PubMed 15227649Avery 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.
- Results publication: PubMed 32532513Lebastchi 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.
- Results publication: PubMed 30638633Shah 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan I Martinez-Salamanca, MD PhD FEBU FACS FEBSM principal investigator
Lyx Institute Urología
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporary prostatic stent (Exime®) and Indwelling catheter in people with Lower Urinary Tract Symptoms and Prostatic Hyperplasia, run by Lyx Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan I Martinez-Salamanca, MD PhD FEBU FACS FEBSM (+34620255030, jims@lyxurologia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device-related quality of life (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05851521, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.