Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05851521
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-09
First Post:
2023-03-22
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
Sponsor:
Lyx Institute
Organization:
Lyx Institute
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HERMES
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 Stentcatheter-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 11 randomization ratio The follow-up duration will be 6 months
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 Stentcatheter-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 11 randomization ratio The follow-up duration will be 6 months
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None