Benign Prostatic HyperplasiaLOCALVAPORNCT06657872
Local Anesthesia With Schelin Catheter in Rezum Treatment: a Randomized Controlled Trial
A study testing water vapor therapy under general anesthesia and water vapor therapy under local anesthesia in people with Benign Prostatic Hyperplasia, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- water vapor therapy under general anesthesia and water vapor therapy under local anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 24 Mar 2025to 24 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred for symptomatic benign prostatic hyperplasia (BPH)
- Men between 45 and 80 years of age
- IPSS > 13
- Qmax <15 ml/s
- Prostate volume between 30 and 80 g on ultrasound
- Patient able to understand study details, benefits and risks
Show all 9Show fewer
- Patient able to give informed consent
- Beneficiary of or affiliated to the French social security system
- Patient having signed an informed consent form
Who cannot join
- 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
- Patient with history of penile implants
- Patient with history of pelvic irradiation
Show all 12Show fewer
- Patient with a symptomatic urinary tract infection in the 10 days prior to surgery
- Presence of bladder stones on ultrasonography
- Patient allergic to lidocaine 2% or any medication used in the pre-operative protocol (anxiolytics, analgesics and non-steroidal anti-inflammatory drugs)
- Patient under guardianship or curatorship
- Protected patient, deprived of liberty
- Patient with a neurological and/or psychiatric disorder making it impossible to understand the terms of the study and to sign an informed consent form
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service d'urologie, Hôpital Nord (AP-HM)
Marseille, 13015
Michael Baboudjian, MD, +33 4 91 96 87 18, michael.baboudjian@ap-hm.fr
About this study
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.
Read the detailed description
Benign prostatic hyperplasia (BPH) is a common age-related pathology, affecting almost one in three men over the age of 50. It is responsible for voiding disorders in men, which can significantly impair quality of life. Briefly, drug treatment is currently used as first-line therapy; in the event of primary or secondary failure, surgery may be indicated. Over the past 25 years, a number of minimally invasive surgical therapies (MIST) have been developed for the treatment of male voiding disorders associated with BPH. MIST should enable rapid and lasting improvement in symptoms and quality of life, preservation of sexual function in contrast to conventional surgical techniques, rapid return to normal daily activity, and a minimal side-effect profile, thus enabling outpatient management. One of the many advantages of these techniques is to avoid the need for general anaesthesia, both for the growing cohort of elderly patients and for younger patients wishing to return to work quickly. In its pilot study, water vapor thermal therapy (RezumTM, Boston Scientific Corporation, Marlborough, MA) was proposed as a minimally invasive procedure, 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, in some ways limiting the concept of a minimally invasive ambulatory surgery approach. In addition, the use of general anesthesia requires the presence of a dedicated anesthesia team, and adds to the burden of the patient journey (pre-operative anesthesia consultation, exposure to anesthetic drugs, passage to recovery room, slower post-operative recovery). From a surgical point of view, recourse to general anesthesia during Rezum treatment adds to an already saturated operative schedule, with significantly increased room occupancy time, for a Rezum therapy whose average operating time is 5 minutes. 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 transurethral route, providing more effective local anesthesia and avoiding the need for transrectal or general anesthesia. This catheter is therefore of crucial use in offering our patients an ultra-minimally invasive treatment, which can be associated with a reduction in room occupancy time, time spent in outpatient surgery, a procedure performed independently of the anesthesia team, and for the patient, an accelerated post-operative recovery.
By delivering the Rezum treatment via the Schelin catheter, our hypothesis is a significant reduction (>20%) in room occupancy time in the operating room, associated with accelerated post-operative recovery for the patient.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- water vapor therapy under general anesthesia, water vapor therapy under local anesthesia
- Keywords
- REZUM, MIST, general anesthesia, local anesthesia
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
water vapor therapy under general anesthesiaProcedure or surgery
Water vapor procedure will be performe under conscious intravenous sedation with anesthesia team
water vapor therapy under local anesthesiaProcedure or 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).
| Study group | Role | What they receive |
|---|---|---|
| general anesthesia | Active comparator | REZUM procedure under general anesthesia Receives: Procedure: water vapor therapy under general anesthesia |
| Local anesthesia | Active comparator | REZUM procedure under local anesthesia Receives: Procedure: water vapor therapy under local anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the operating room occupancy time between the 2 groups
Operating room occupancy time during REZUM procedure
Measured: Visit 2: surgery
Secondary outcomes (5)
Comparison of the quality of recovery after surgery between the 2 groups
Quality of recovery-15 scores (QoR-15)
Measured: 24h after surgery
Comparison of the pain post-surgery between the 2 groups
Numerical pain rating scale (0-10)
Measured: 1 hour, 2 hours and 24 hours after surgery
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
Measured: intraoperative
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
Measured: 3 months post-surgery
Comparison of the average number of side-effects post-surgery between the 2 groups
Post-operative side effects reported using the Clavien-Dindo classification
Measured: 30 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start24 Mar 2025
- Primary completion24 Nov 2026 (estimated)
- Study completion24 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657872
- Sponsor's protocol ID
- RCAPHM24_0263
- Other IDs
- 2024-A01800-47
- Acronym
- LOCALVAPOR
- Status last verified
- Feb 2026
- First submitted
- 21 Oct 2024
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Anesthesia With Schelin Catheter in Rezum Treatment: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06657872
- Acronym / sponsor ID
- LOCALVAPOR / RCAPHM24_0263
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- REZUM, MIST, general anesthesia, local anesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- 24 Nov 2026 (estimated)
- Study completion
- 24 Nov 2026 (estimated)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Benign prostatic hyperplasia (BPH) is a common age-related pathology, affecting almost one in three men over the age of 50. It is responsible for voiding disorders in men, which can significantly impair quality of life. Briefly, drug treatment is currently used as first-line therapy; in the event of primary or secondary failure, surgery may be indicated. Over the past 25 years, a number of minimally invasive surgical therapies (MIST) have been developed for the treatment of male voiding disorders associated with BPH. MIST should enable rapid and lasting improvement in symptoms and quality of life, preservation of sexual function in contrast to conventional surgical techniques, rapid return to normal daily activity, and a minimal side-effect profile, thus enabling outpatient management. One of the many advantages of these techniques is to avoid the need for general anaesthesia, both for the growing cohort of elderly patients and for younger patients wishing to return to work quickly. In its pilot study, water vapor thermal therapy (RezumTM, Boston Scientific Corporation, Marlborough, MA) was proposed as a minimally invasive procedure, 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, in some ways limiting the concept of a minimally invasive ambulatory surgery approach. In addition, the use of general anesthesia requires the presence of a dedicated anesthesia team, and adds to the burden of the patient journey (pre-operative anesthesia consultation, exposure to anesthetic drugs, passage to recovery room, slower post-operative recovery). From a surgical point of view, recourse to general anesthesia during Rezum treatment adds to an already saturated operative schedule, with significantly increased room occupancy time, for a Rezum therapy whose average operating time is 5 minutes. 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 transurethral route, providing more effective local anesthesia and avoiding the need for transrectal or general anesthesia. This catheter is therefore of crucial use in offering our patients an ultra-minimally invasive treatment, which can be associated with a reduction in room occupancy time, time spent in outpatient surgery, a procedure performed independently of the anesthesia team, and for the patient, an accelerated post-operative recovery.
By delivering the Rezum treatment via the Schelin catheter, our hypothesis is a significant reduction (>20%) in room occupancy time in the operating room, associated with accelerated post-operative recovery for the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| general anesthesia | Active comparator | Procedure: water vapor therapy under general anesthesiaREZUM procedure under general anesthesia |
| Local anesthesia | Active comparator | Procedure: water vapor therapy under local anesthesiaREZUM procedure under local anesthesia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients referred for symptomatic benign prostatic hyperplasia (BPH)
- Men between 45 and 80 years of age
- IPSS > 13
- Qmax <15 ml/s
- Prostate volume between 30 and 80 g on ultrasound
Key exclusion criteria (12 listed)
- 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
- Patient with history of penile implants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| water vapor therapy under general anesthesiaWater vapor procedure will be performe under conscious intravenous sedation with anesthesia team | Procedure or surgery | general anesthesia |
| water vapor therapy under local anesthesiaWater 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). | Procedure or surgery | Local anesthesia |
Primary outcome
Comparison of the operating room occupancy time between the 2 groups
Time frame: Visit 2: surgery
Operating room occupancy time during REZUM procedure
5 secondary outcomes
Comparison of the quality of recovery after surgery between the 2 groups
Time frame: 24h after surgery
Comparison of the pain post-surgery between the 2 groups
Time frame: 1 hour, 2 hours and 24 hours after surgery
Success rate of the local anesthesia for the REZUM procedure
Time frame: intraoperative
Comparison of functional results between the 2 groups
Time frame: 3 months post-surgery
Comparison of the average number of side-effects post-surgery between the 2 groups
Time frame: 30 days post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing water vapor therapy under general anesthesia and water vapor therapy under local anesthesia in people with Benign Prostatic Hyperplasia, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Baboudjian, MD (04.91.96.87.18, michael.baboudjian@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the operating room occupancy time between the 2 groups (time frame: Visit 2: surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.