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Post-operative placement of temporary prostatic stent (EXIME)

Post-operative placement of indwelling catheter

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

Temporary prostatic stent (Exime®)

Indwelling catheter

Juan I Martinez-Salamanca, MD PhD FEBU FACS FEBSM

Juan I Martínez-Salamanca, MD

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.

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.

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

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

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)

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

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

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.

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)

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.

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.

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.

Spots Global Cancer Trial Database for temporary prostatic stent (exime®)