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)

Study Overview
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Brief Summary
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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 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.

Official Title
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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

Conditions
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Lower Urinary Tract Symptoms, Prostatic Hyperplasia, Prostatic Cancer, Urinary Retention

Intervention / Treatment
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* Device: Temporary prostatic stent (Exime®)
* Device: Indwelling catheter


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Temporary prostatic stent (Exime®)<br>Post-operative placement of temporary prostatic stent (EXIME) | Device: Temporary prostatic stent (Exime®)<br>* Placement of temporary prostatic stent (Exime®) following the procedure described in the product information<br>|
| Active Comparator: Indwelling catheter<br>Post-operative placement of indwelling catheter | Device: Indwelling catheter<br>* Placement of indwelling catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Temporary prostatic stent, Indwelling catheter, Cryotherapy, Prostate cancer, Benign prostatic hyperplasia, Rezum, EchoLaser