About this trial
In a pilot study, water vapor therapy (RezumTM, Boston Scientific Corporation, Marlborough, MA) was proposed as a minimally invasive procedure for benign prostatic hyperplasia, but often requiring oral ± intravenous sedation or a transrectal prostatic block. Therefore, pain management during Rezum therapy remains a challenge and may lead to the use of pain control protocols and general anesthesia, limiting in some ways the concept of a minimally invasive ambulatory surgical approach. The Schelin® catheter (ProstaLund AB, Lund, Sweden), approved by the European Medicines Agency, is a device for injecting analgesic drugs directly into the prostate via the trans-urethral route, providing more effective local anesthesia and avoiding the need for transrectal route or general anesthesia. This catheter is therefore of crucial importance in offering to our patients an ultra-minimally invasive treatment, associated with a reduction in room occupancy time, outpatient surgery time, a procedure performed independently of the anesthesia team, and for the patient, an accelerated post-operative recovery. Our hypothesis is that the REZUM procedure under local anesthesia could be associated with a \>20% reduction in operating room occupancy time compared to procedures performed under general anesthesia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients referred for symptomatic benign prostatic hyperplasia (BPH)
Men between 45 and 80 years of age
IPSS > 13
Qmax <15 ml/s
Disqualifiers
Patients with a history of prostate cancer
Patient with history of BPH surgery
Patients with a history of neurological bladder disease
Patient with history of urethral stricture
Trial design
Parallel
Treatments tested in this trial
water vapor therapy under general anesthesia
Procedure/SurgeryWater vapor procedure will be performe under conscious intravenous sedation with anesthesia team
water vapor therapy under local anesthesia
Procedure/SurgeryWater vapor procedure will be performe under local anethesia administrated with Schelin® catheter via the trans-urethral route : injection of 20cc of lidocaine 2% intra-prostatically via the schelin catheter at 4 injection points (3cc at 1h, 3cc at 11h, 7cc at 4h, and 7cc at 8h).
Treatment groups
Trial outcomes
Primary outcomes
Comparison of the operating room occupancy time between the 2 groups
Operating room occupancy time during REZUM procedure
Secondary outcomes
Comparison of the quality of recovery after surgery between the 2 groups
Quality of recovery-15 scores (QoR-15)
Comparison of the pain post-surgery between the 2 groups
Numerical pain rating scale (0-10)
Success rate of the local anesthesia for the REZUM procedure
* Number of patients with intraoperative anesthesia changes * Numerical pain rating scale (0-10) during surgery
Comparison of functional results between the 2 groups
urinary function assessment: * International Prostate Symptom Score * International Prostate Symptom Score - Quality of Life * Uriflometry (Qmax) Sexual function assessment: * International Index of Erectile Function * Male Sexual Health Questionnaire
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