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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Device-related quality of life
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Temporary prostatic stent (Exime®)
Post-operative placement of temporary prostatic stent (EXIME)
Intervention: Temporary prostatic stent (Exime®) (Device)
Indwelling catheter
Post-operative placement of indwelling catheter
Intervention: Indwelling catheter (Device)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Overall satisfaction outcomes(4 week)
- Urine flow rate(From device-placement to 6 months after treatment)
- Device-related patient satisfaction(1 week)
- Device-related Lower Urinary Tract Symptoms (LUTS)(From device-placement to 6 months after treatment)
- Occurrence of postoperative events (>24h-1week)(1 week)
- Device-related urinary side effects(1 week)
- Occurence of perioperative events (< or = 24h after treatment)(1 post-operative day)
- Device-related continence symptoms(From device-placement to 6 months after treatment)