Local Anesthesia With Schelin Catheter in Rezum Treatment: a Randomized Controlled Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-80
SponsorAssistance Publique Hopitaux De Marseille

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • water vapor therapy under general anesthesia

    Procedure/Surgery

    Water vapor procedure will be performe under conscious intravenous sedation with anesthesia team

  • water vapor therapy under local anesthesia

    Procedure/Surgery

    Water 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

24 Participants
are divided into 2 treatment groups
Group A: general anesthesiaActive comparator 1 intervention
Group B: Local anesthesiaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Comparison of the operating room occupancy time between the 2 groups

Operating room occupancy time during REZUM procedure

Time frame
Visit 2: surgery

Secondary outcomes

1

Comparison of the quality of recovery after surgery between the 2 groups

Quality of recovery-15 scores (QoR-15)

Time frame
24h after surgery
2

Comparison of the pain post-surgery between the 2 groups

Numerical pain rating scale (0-10)

Time frame
1 hour, 2 hours and 24 hours after surgery
3

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

Time frame
intraoperative
4

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

Time frame
3 months post-surgery

Other outcomes

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