To Evaluate LUTS and Complications Between Indwelling Catheter and Temporary Prostatic Stent in P… (NCT05851521) | Clinical Trial Compass
UnknownNot Applicable
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)
Spain120 participantsStarted 2023-06
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.