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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)

Primary Purpose

Lower Urinary Tract Symptoms, Prostatic Hyperplasia, Prostatic Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Temporary prostatic stent (Exime®)
Indwelling catheter
Sponsored by
Lyx Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Urinary Tract Symptoms focused on measuring Temporary prostatic stent, Indwelling catheter, Cryotherapy, Prostate cancer, Benign prostatic hyperplasia, Rezum, EchoLaser

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Juan Ignacio Martinez-Salamanca

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Temporary prostatic stent (Exime®)

Indwelling catheter

Arm Description

Post-operative placement of temporary prostatic stent (EXIME)

Post-operative placement of indwelling catheter

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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
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
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.
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)
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.
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.
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.

Full Information

First Posted
March 22, 2023
Last Updated
May 1, 2023
Sponsor
Lyx Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05851521
Brief 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)
Acronym
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lyx Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Urinary Tract Symptoms, Prostatic Hyperplasia, Prostatic Cancer, Urinary Retention
Keywords
Temporary prostatic stent, Indwelling catheter, Cryotherapy, Prostate cancer, Benign prostatic hyperplasia, Rezum, EchoLaser

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Temporary prostatic stent (Exime®)
Arm Type
Experimental
Arm Description
Post-operative placement of temporary prostatic stent (EXIME)
Arm Title
Indwelling catheter
Arm Type
Active Comparator
Arm Description
Post-operative placement of indwelling catheter
Intervention Type
Device
Intervention Name(s)
Temporary prostatic stent (Exime®)
Intervention Description
Placement of temporary prostatic stent (Exime®) following the procedure described in the product information
Intervention Type
Device
Intervention Name(s)
Indwelling catheter
Intervention Description
Placement of indwelling catheter
Primary Outcome Measure Information:
Title
Device-related quality of life
Description
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
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Device-related urinary side effects
Description
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)
Time Frame
1 week
Title
Device-related patient satisfaction
Description
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
Time Frame
1 week
Title
Device-related Lower Urinary Tract Symptoms (LUTS)
Description
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
Time Frame
From device-placement to 6 months after treatment
Title
Occurence of perioperative events (< or = 24h after treatment)
Description
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.
Time Frame
1 post-operative day
Title
Occurrence of postoperative events (>24h-1week)
Description
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)
Time Frame
1 week
Title
Overall satisfaction outcomes
Description
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.
Time Frame
4 week
Title
Urine flow rate
Description
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.
Time Frame
From device-placement to 6 months after treatment
Title
Device-related continence symptoms
Description
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.
Time Frame
From device-placement to 6 months after treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan I Martinez-Salamanca, MD PhD FEBU FACS FEBSM
Phone
+34620255030
Email
jims@lyxurologia.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan I Martinez-Salamanca, MD PhD FEBU FACS FEBSM
Organizational Affiliation
Lyx Institute Urología
Official's Role
Principal Investigator
Facility Information:
Facility Name
Juan Ignacio Martinez-Salamanca
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan I Martínez-Salamanca, MD
Phone
+34620255030
Email
jims@lyxurologia.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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16843240
Citation
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Citation
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Learn more about this trial

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)

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