Clinical trial NCT05851521: 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)
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lower Urinary Tract Symptoms
Prostatic Hyperplasia
Prostatic Cancer
Urinary Retention
Keywords: Temporary prostatic stent
Indwelling catheter
Cryotherapy
Prostate cancer
Benign prostatic hyperplasia
Rezum
EchoLaser
Lead sponsor: Lyx Institute
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Device-related quality of life
timeFrame: 1 week
Secondary outcomes:
measure: Device-related urinary side effects
timeFrame: 1 week
measure: Device-related patient satisfaction
timeFrame: 1 week
measure: Device-related Lower Urinary Tract Symptoms (LUTS)
timeFrame: From device-placement to 6 months after treatment
measure: Occurence of perioperative events (< or = 24h after treatment)
timeFrame: 1 post-operative day
measure: Occurrence of postoperative events (>24h-1week)
timeFrame: 1 week
measure: Overall satisfaction outcomes
timeFrame: 4 week
measure: Urine flow rate
timeFrame: From device-placement to 6 months after treatment
measure: Device-related continence symptoms
timeFrame: From device-placement to 6 months after treatment
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Juan Ignacio Martinez-Salamanca
Study officials:
affiliation: Lyx Institute Urología
name: Juan I Martinez-Salamanca, MD PhD FEBU FACS FEBSM
role: PRINCIPAL_INVESTIGATOR
References:
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