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)

May 1, 2023 updated by: Lyx Institute

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:

  • 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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Juan I Martinez-Salamanca, MD PhD FEBU FACS FEBSM
  • Phone Number: +34620255030
  • Email: jims@lyxurologia.com

Study Locations

  • Spain
      • Madrid, Spain, 28006
        • Juan Ignacio Martinez-Salamanca
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device-related urinary side effects
Time Frame: 1 week

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
Time Frame: 1 week

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)
Time Frame: From device-placement to 6 months after treatment

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)
Time Frame: 1 post-operative day
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)
Time Frame: 1 week
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
Time Frame: 4 week
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
Time Frame: From device-placement to 6 months after 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.
From device-placement to 6 months after treatment
Device-related continence symptoms
Time Frame: From device-placement to 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.
From device-placement to 6 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lyx Institute

Investigators

  • Principal Investigator: Juan I Martinez-Salamanca, MD PhD FEBU FACS FEBSM, Lyx Institute Urología

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2023

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

June 1, 2025

Study Registration Dates

First Submitted

March 22, 2023

First Submitted That Met QC Criteria

May 1, 2023

First Posted (Actual)

May 9, 2023

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 1, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HERMES01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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