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)

Lyx Institute

Status: Not yet enrolling

Conditions: Urinary Retention; Lower Urinary Tract Symptoms; Prostatic Cancer; Prostatic Hyperplasia

Treatments: Device: Indwelling catheter; Device: Temporary prostatic stent (Exime®)

Study type: Interventional

Funder types: Other

Identifiers

NCT05851521

HERMES01

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Male

Ages: 18 to 85 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Temporary prostatic stent (Exime®)

Experimental group

Description:

Post-operative placement of temporary prostatic stent (EXIME)

Treatment:

Device: Temporary prostatic stent (Exime®)

Indwelling catheter

Active Comparator group

Description:

Post-operative placement of indwelling catheter

Treatment:

Device: Indwelling catheter