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Trial Title:
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)
NCT ID:
NCT05851521
Condition:
Lower Urinary Tract Symptoms
Prostatic Hyperplasia
Prostatic Cancer
Urinary Retention
Conditions: Official terms:
Prostatic Neoplasms
Prostatic Hyperplasia
Urinary Retention
Hyperplasia
Lower Urinary Tract Symptoms
Conditions: Keywords:
Temporary prostatic stent
Indwelling catheter
Cryotherapy
Prostate cancer
Benign prostatic hyperplasia
Rezum
EchoLaser
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Temporary prostatic stent (Exime®)
Description:
Placement of temporary prostatic stent (Exime®) following the procedure described in the
product information
Arm group label:
Temporary prostatic stent (Exime®)
Intervention type:
Device
Intervention name:
Indwelling catheter
Description:
Placement of indwelling catheter
Arm group label:
Indwelling catheter
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.
Criteria for 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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Juan Ignacio Martinez-Salamanca
Address:
City:
Madrid
Zip:
28006
Country:
Spain
Contact:
Last name:
Juan I Martínez-Salamanca, MD
Phone:
+34620255030
Email:
jims@lyxurologia.com
Start date:
June 2023
Completion date:
June 2025
Lead sponsor:
Agency:
Lyx Institute
Agency class:
Other
Source:
Lyx Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05851521
