Benign Prostatic HyperplasiaNCT06794333
Single Center Comparative Trial of Trans-Perineal Laser Ablation Vs Water Vapor Ablation
A study testing Transperineal laser Ablation and Rezum Vapor Therapy in people with Benign Prostatic Hyperplasia, run by University of Pisa at 1 site in Italy.
Trial summary
The primary aim of this clinical trial is to determine whether one of the two methods under investigation, TPLA or WVA, is superior in the treatment of BPH. Additionally, as a secondary objective, the study seeks to evaluate the potential superiority of one method over the other concerning the sexual parameters of… Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Transperineal laser Ablation and Rezum Vapor Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jan 2024to 15 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PSA levels under 4 ng/ml (if PSA is over 4 ng/ml, a multiparametric prostate magnetic resonance will be performed; if a lesion with a PIRADS score over 2 is detected, a prostate biopsy will be conducted);
- Post void residual (PVR) over 50 ml;
- Maximum flow (Qmax) under 15 ml/s;
- IPSS score over 7;
- The possibility of undergoing transrectal ultrasound to assess the size of the prostate and prostate adenoma;
- Negative urinary culture.
Who cannot join
- Diabetes;
- Overactive or Underachieve bladder;
- Contraindications for performing MRI or prostate biopsy in cases where PSA is over 4 ng/ml;
- Intolerance to transrectal ultrasound;
- Intolerance or allergy to local anesthetics.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Efficacy of Trans-Perineal Laser Ablation Vs Water Vapor Ablation for Benign Prostatic Hyperplasia: a Single Center Randomized Controlled Trial
The primary aim of this clinical trial is to determine whether one of the two methods under investigation, TPLA or WVA, is superior in the treatment of BPH. Additionally, as a secondary objective, the study seeks to evaluate the potential superiority of one method over the other concerning the sexual parameters of treated participants, assessed using the International Index of Erectile Function 5 (IIEF5) and the Male Sexual Health Questionnaire - Ejaculatory Dysfunction (MSHQ-EJ).
The researchers will compare the two methods under investigation (TPLA and WVA) to assess the potential superiority of one over the other.
Read more
Participants will:
- be randomized 1:1 between the two techniques and will undergo treatment at time 0;
- undergo follow-up including uroflowmetry and assessment of the International Prostate Symptoms Score (IPSS), IIEF5, and MSHQ-EJ questionnaires at 3, 6, and 12 months.
Read the detailed description
Therapeutic options for the treatment of benign prostatic hyperplasia (BPH) encompass a wide range of both pharmacological and surgical approaches. BPH is an age-related condition that increasingly affects relatively younger individuals, starting from the age of 50.
Pharmacological therapy primarily involves medications that can alleviate symptoms but do not cure or lead to a regression of the prostate gland enlargement over time.
Surgical therapy aims to reduce the degree of obstruction, and in most cases, it can result in significant alterations in sexual function, such as inducing retrograde ejaculation or causing erectile dysfunction. These side effects are more common with the use of classical treatment methods, whose clinical value is widely recognized and confirmed by clinical evidence reported in international guidelines (EAU Guidelines, 2021 edition).
The classical surgical treatment methods include the removal of the adenoma (benign hyperplastic part of the prostate gland) through open surgery, transurethral resection (TURP), laser ablation with en bloc removal (holmium and thulium lasers), or direct cavitation (green light laser). These classical methods typically require hospital admission with a stay of three days or more, depending on the extent of postoperative bleeding and the risk of post-surgical obstructive complications (bladder clots).
On the other hand, some minimally invasive and innovative methods can reduce the symptoms caused by the disease while preserving the patient's sexual function. These techniques also allow for treatment without hospitalization or, at most, in a outpatients setting, utilizing local anesthesia or sedation and presenting a low risk of bleeding or other complications. Specifically, the minimally invasive technologies aim for thermal ablation of the hyperplastic tissue without cavitation. This approach results in longer healing times and clinical improvement, as they are dependent on cellular apoptosis, tissue necrosis, and spontaneous gland remodeling, which occur in the months following treatment, thus not producing immediate visible or effective results.
These methods include Rezum (WVA), I-Tind, and SoracteLite trans-perineal laser ablation (TPLA). All of these minimally invasive methods have been extensively validated by clinical studies and scientific evidence.
SoracteLite-TPLA increases the temperature of the treated tissue through the absorption of laser radiation delivered to the targeted tissue by very thin optical fibers inserted perineally. Exposure to high temperatures causes coagulative necrosis of the tissues. In contrast, WVA involves the transurethral injection of water vapor through a radiofrequency needle. The local temperature increase generated by radiofrequency and water vapor leads to progressive tissue necrosis, reducing the size of the prostate adenoma and significantly improving urinary flow.
It is also logical that the use of minimally invasive methods allows for treating a larger number of patients with a lower risk of complications, although with an apparently reduced effectiveness in deobstruction compared to classical methods. The economic and social advantages are further highlighted by the faster resolution of waiting lists and greater psychological acceptance by the patient, due to the preservation of certain sexual functions and the reduced personal burden associated with the complex system of hospitalization/anesthesia/surgery/outcomes.
The primary objective is to evaluate the efficacy of TPLA vs WVA treatment at 3, 6, and 12 months in patients with BPH in terms of improvement in uroflowmetry parameters and symptoms. Specifically, the uroflowmetry parameters analyzed include maximum flow (Qmax), average flow (Qmed), and post-void residual (PVR). For symptom assessment, the IPSS questionnaire will be used.
The secondary objective includes evaluating the impact of these methods on the sexual health of treated participants through the IIEF5 and MSHQ-EJ questionnaires, which will be administered at 3, 6, and 12 months.
All participants will therefore undergo follow-up at 3, 6, and 12 months, during which they will undergo uroflowmetry with recording of Qmax, Qmed, and PVR parameters, as well as administration of the IPSS, IIEF5, and MSHQ-EJ questionnaires. This is a single-center randomized clinical trial in which participants are randomized 1:1 into the two treatment arms by the researchers.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Transperineal laser Ablation, Rezum Vapor Therapy
- Keywords
- Benign Prostatic Hyperplasia, MISTs, LUTS, Rezum Vapor Therapy, Transperineal Laser Ablation
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transperineal laser AblationProcedure or surgery
Also called EchoLaser EVO
Treatments are performed with the combined EchoLaser EVO system (Elesta SpA - Calenzano, FI). The EchoLaser EVO consists of the Echolaser X4, a multi-source laser system with a wavelength of 1064 nm, and the Echolaser Smart Interface (ESI). The procedure are performed with the patient in the lithotomy position. Local anesthesia of the perineal region and periprostatic block with lidocaine is administered under ultrasound guidance. A catheter is placed during the irradiation to allow continuous irrigation of the urethra with saline solution, protecting the urethra from temperature rise. The Echolaser Smart Interface, defines: the number and positioning of fibers, the optimal dose, and the need for multiple pullbacks. 2 to 4 21G needles are inserted simultaneously (1 or 2 per lobe) in the peri-urethral area via transperineal ultrasound guidance. A 300-micron optical fiber will be placed in each needle. Each treatment delivers a maximum energy of 1800 J per fiber with a power of 3-5 W.
Rezum Vapor TherapyProcedure or surgery
The treatment involves the insertion of a radiofrequency needle into the prostate tissue and the emission of water vapor. Treatment under local anesthesia/sedation. Treatment planning using the REZUM device, with the number of injections proportional to the recommended therapeutic scheme based on prostate volume (1 injection every centimeter starting 1 cm below the bladder neck and 1 cm in front of the verumontanum). Water vapor emission for 9-second intervals with a maximum of 9 applications per patient. Three-way bladder catheter to decrease local temperature. The bladder catheter will be removed 15 days after patient discharge. Regarding the REZUM, it is a system that uses sterile single-use handpieces available within the company, where a special optics is inserted for direct visualization. The handpiece features a device that allows the manual insertion of a needle into the prostate, from which water vapor is emitted for the described treatment.
| Study group | Role | What they receive |
|---|---|---|
| Transperineal Laser Ablation | Experimental | Treatments are performed with the combined EchoLaser EVO system (Elesta SpA - Calenzano, FI). The EchoLaser EVO consists of the Echolaser X4, a multi-source laser system with a wavelength of 1064 nm, and the Echolaser Smart Interface (ESI).
The procedure are performed with the patient in the lithotomy position. Local anesthesia of the perineal region and periprostatic block with lidocaine is administered under ultrasound guidance. A catheter is placed during the irradiation to allow continuous irrigation of the urethra with saline solution, protecting the urethra from temperature rise. The Echolaser Smart Interface, defines: the number and positioning of fibers, the optimal dose, and the need for multiple pullbacks. 2 to 4 21G needles are inserted simultaneously (1 or 2 per lobe) in the peri-urethral area via transperineal ultrasound guidance. A 300-micron optical fiber will be placed in each needle. Each treatment delivers a maximum energy of 1800 J per fiber with a power of 3-5 W. Receives: Procedure: Transperineal laser Ablation |
| Rezum Vapor Therapy | Active comparator | The treatment involves the insertion of a radiofrequency needle into the prostate tissue and the emission of water vapor.
Treatment under local anesthesia/sedation. Treatment planning using the REZUM device, with the number of injections proportional to the recommended therapeutic scheme based on prostate volume (1 injection every centimeter starting 1 cm below the bladder neck and 1 cm in front of the verumontanum).
Water vapor emission for 9-second intervals with a maximum of 9 applications per patient.
Three-way bladder catheter to decrease local temperature. The bladder catheter will be removed 15 days after patient discharge. Regarding the REZUM, it is a system that uses sterile single-use handpieces available within the company, where a special optics is inserted for direct visualization. The handpiece features a device that allows the manual insertion of a needle into the prostate, from which water vapor is emitted for the described treatment. Receives: Procedure: Rezum Vapor Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of Urodynamics parameters after 3 and 12 Months of Follow up
After 3,6 and 12 months of follow-up, uroflowmetry will be conducted to assess improvements in urinary maximum flow (Qmax: ml/sec) and average flow (Qmed: ml/sec). Milliliters and seconds will be combined to calculate and report Qmax and Qmed.
Measured: up to 12 months
Improvement in post voided residual
After 3,6 and 12 months of follow-up, uroflowmetry will be conducted to assess improvements post voided residual (PVR: ml). Milliliters will be used to report PVR.
Measured: up to 12 months
Improvement in International Prostate Symptoms Score
After 3,6 and 12 months of follow-up International Prostate Symptom Score (IPSS) questionnaire will be administered to all participants to evaluate changes in subjective symptoms and quality of life (Lower IPSS values indicate an improvement in the symptoms reported by the patient). The IPSS ranges from 0 to 35, with scores interpreted as follows: 0-7 indicates mild symptoms, 8-19 indicates moderate symptoms, and 20-35 indicates severe symptoms.
Measured: up to 12 months
Secondary outcomes (4)
Postoperative complications
Evaluate the incidence of postoperative complications according to Calvin Dindo Classification.
The Clavien-Dindo classification categorizes complications related to a surgical procedure on a scale from 1 to 5. The severity of the complication increases with higher Clavien-Dindo scores.
Measured: up to 3 months
Prostate Specific Antigen (PSA) value
To evaluate the PSA levels at 3,6 and 12 months. PSA will be reported by combining nanograms and milliliters (ng/ml).
Measured: up to 12 months
sexual outcomes
To assess the impact of the procedures on penile erection, we will use the International Index of Erectile Function (IIEF5) questionnaire.
The two questionnaires do not have units of measurement; they are expressed in absolute numbers. Higher IIEF5 values indicate better erectile function.
The IIEF-5 score ranges from 0 to 25. Scores of 22 to 25 indicate normal erectile function, while scores of 17 to 21 suggest mild erectile dysfunction. Scores between 12 and 16 indicate mild-to-moderate dysfunction, 8 to 11 moderate dysfunction, and scores below 7 indicate severe erectile dysfunction.
Measured: up to 12 months
sexual outcomes
To assess the impact of the procedures on anterograde ejaculatory function, we will use the Male Sexual Health Questionnaire - Ejaculation Disfunction (MSHQ-EJD).
Higher scores reflect better ejaculatory function, with the questionnaire ranging from 0 to 15. Additionally, a final question, scored from 0 to 5, assesses the difficulty experienced by the patient during ejaculation. For this specific question, higher scores correspond to greater levels of difficulty reported (0: no difficulty, 5: extremely bothered).
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start8 Jan 2024
- Primary completion5 Jul 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ALESSANDRO ZUCCHI, University of Pisa
- Investigators
- Alessandro Zucchi, Professor, Study chair, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794333
- Sponsor's protocol ID
- SPIT_2
- Other IDs
- PROGETTO SMART REGIONE TOSCANA
- Status last verified
- May 2024
- First submitted
- 16 Oct 2024
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van Riel LAMJG, van Kollenburg RAA, Vis AN, van Leeuwen PJ, de Reijke TM, de Bruin DM, Oddens JR. Safety and Feasibility of Soractelite Transperineal Focal Laser Ablation for Prostate Cancer and Short-term Quality of Life Analysis from a Multicenter Pilot Study. Eur Urol Open Sci. 2022 Apr 2;39:48-54. doi: 10.1016/j.euros.2022.02.012. eCollection 2022 May.
PubMed 35528781McVary KT, Roehrborn CG. Three-Year Outcomes of the Prospective, Randomized Controlled Rezum System Study: Convective Radiofrequency Thermal Therapy for Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia. Urology. 2018 Jan;111:1-9. doi: 10.1016/j.urology.2017.10.023. Epub 2017 Nov 6.
PubMed 29122620Patelli G, Ranieri A, Paganelli A, Mauri G, Pacella CM. Transperineal Laser Ablation for Percutaneous Treatment of Benign Prostatic Hyperplasia: A Feasibility Study. Cardiovasc Intervent Radiol. 2017 Sep;40(9):1440-1446. doi: 10.1007/s00270-017-1662-9. Epub 2017 May 4.
PubMed 28474112Pacella CM, Patelli G, Iapicca G, Manenti G, Perretta T, Ryan CP, Esposito R, Mauri G. Transperineal laser ablation for percutaneous treatment of benign prostatic hyperplasia: a feasibility study. Results at 6 and 12 months from a retrospective multi-centric study. Prostate Cancer Prostatic Dis. 2020 Jun;23(2):356-363. doi: 10.1038/s41391-019-0196-4. Epub 2019 Dec 11.
PubMed 31827239
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Trans-Perineal Laser Ablation Vs Water Vapor Ablation for Benign Prostatic Hyperplasia: a Single Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06794333
- Acronym / sponsor ID
- SPIT_2
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Benign Prostatic Hyperplasia, MISTs, LUTS, Rezum Vapor Therapy, Transperineal Laser Ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 5 Jul 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 27 Jan 2025 (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.
The primary aim of this clinical trial is to determine whether one of the two methods under investigation, TPLA or WVA, is superior in the treatment of BPH. Additionally, as a secondary objective, the study seeks to evaluate the potential superiority of one method over the other concerning the sexual parameters of treated participants, assessed using the International Index of Erectile Function 5 (IIEF5) and the Male Sexual Health Questionnaire - Ejaculatory Dysfunction (MSHQ-EJ).
The researchers will compare the two methods under investigation (TPLA and WVA) to assess the potential superiority of one over the other.
Participants will:
- be randomized 1:1 between the two techniques and will undergo treatment at time 0;
- undergo follow-up including uroflowmetry and assessment of the International Prostate Symptoms Score (IPSS), IIEF5, and MSHQ-EJ questionnaires at 3, 6, and 12 months.
Detailed description
Therapeutic options for the treatment of benign prostatic hyperplasia (BPH) encompass a wide range of both pharmacological and surgical approaches. BPH is an age-related condition that increasingly affects relatively younger individuals, starting from the age of 50.
Pharmacological therapy primarily involves medications that can alleviate symptoms but do not cure or lead to a regression of the prostate gland enlargement over time.
Surgical therapy aims to reduce the degree of obstruction, and in most cases, it can result in significant alterations in sexual function, such as inducing retrograde ejaculation or causing erectile dysfunction. These side effects are more common with the use of classical treatment methods, whose clinical value is widely recognized and confirmed by clinical evidence reported in international guidelines (EAU Guidelines, 2021 edition).
The classical surgical treatment methods include the removal of the adenoma (benign hyperplastic part of the prostate gland) through open surgery, transurethral resection (TURP), laser ablation with en bloc removal (holmium and thulium lasers), or direct cavitation (green light laser). These classical methods typically require hospital admission with a stay of three days or more, depending on the extent of postoperative bleeding and the risk of post-surgical obstructive complications (bladder clots).
On the other hand, some minimally invasive and innovative methods can reduce the symptoms caused by the disease while preserving the patient's sexual function. These techniques also allow for treatment without hospitalization or, at most, in a outpatients setting, utilizing local anesthesia or sedation and presenting a low risk of bleeding or other complications. Specifically, the minimally invasive technologies aim for thermal ablation of the hyperplastic tissue without cavitation. This approach results in longer healing times and clinical improvement, as they are dependent on cellular apoptosis, tissue necrosis, and spontaneous gland remodeling, which occur in the months following treatment, thus not producing immediate visible or effective results.
These methods include Rezum (WVA), I-Tind, and SoracteLite trans-perineal laser ablation (TPLA). All of these minimally invasive methods have been extensively validated by clinical studies and scientific evidence.
SoracteLite-TPLA increases the temperature of the treated tissue through the absorption of laser radiation delivered to the targeted tissue by very thin optical fibers inserted perineally. Exposure to high temperatures causes coagulative necrosis of the tissues. In contrast, WVA involves the transurethral injection of water vapor through a radiofrequency needle. The local temperature increase generated by radiofrequency and water vapor leads to progressive tissue necrosis, reducing the size of the prostate adenoma and significantly improving urinary flow.
It is also logical that the use of minimally invasive methods allows for treating a larger number of patients with a lower risk of complications, although with an apparently reduced effectiveness in deobstruction compared to classical methods. The economic and social advantages are further highlighted by the faster resolution of waiting lists and greater psychological acceptance by the patient, due to the preservation of certain sexual functions and the reduced personal burden associated with the complex system of hospitalization/anesthesia/surgery/outcomes.
The primary objective is to evaluate the efficacy of TPLA vs WVA treatment at 3, 6, and 12 months in patients with BPH in terms of improvement in uroflowmetry parameters and symptoms. Specifically, the uroflowmetry parameters analyzed include maximum flow (Qmax), average flow (Qmed), and post-void residual (PVR). For symptom assessment, the IPSS questionnaire will be used.
The secondary objective includes evaluating the impact of these methods on the sexual health of treated participants through the IIEF5 and MSHQ-EJ questionnaires, which will be administered at 3, 6, and 12 months.
All participants will therefore undergo follow-up at 3, 6, and 12 months, during which they will undergo uroflowmetry with recording of Qmax, Qmed, and PVR parameters, as well as administration of the IPSS, IIEF5, and MSHQ-EJ questionnaires. This is a single-center randomized clinical trial in which participants are randomized 1:1 into the two treatment arms by the researchers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transperineal Laser Ablation | Experimental | Procedure: Transperineal laser AblationTreatments are performed with the combined EchoLaser EVO system (Elesta SpA - Calenzano, FI). The EchoLaser EVO consists of the Echolaser X4, a multi-source laser system with a wavelength of 1064 nm, and the Echolaser Smart Interface (ESI). The procedure are performed with the patient in the lithotomy position. Local anesthesia of the perineal region and periprostatic block with lidocaine is administered under ultrasound guidance. A catheter is placed during the irradiation to allow continuous irrigation of the urethra with saline solution, protecting the urethra from temperature rise. The Echolaser Smart Interface, defines: the number and positioning of fibers, the optimal dose, and the need for multiple pullbacks. 2 to 4 21G needles are inserted simultaneously (1 or 2 per lobe) in the peri-urethral area via transperineal ultrasound guidance. A 300-micron optical fiber will be placed in each needle. Each treatment delivers a maximum energy of 1800 J per fiber with a power of 3-5 W. |
| Rezum Vapor Therapy | Active comparator | Procedure: Rezum Vapor TherapyThe treatment involves the insertion of a radiofrequency needle into the prostate tissue and the emission of water vapor. Treatment under local anesthesia/sedation. Treatment planning using the REZUM device, with the number of injections proportional to the recommended therapeutic scheme based on prostate volume (1 injection every centimeter starting 1 cm below the bladder neck and 1 cm in front of the verumontanum). Water vapor emission for 9-second intervals with a maximum of 9 applications per patient. Three-way bladder catheter to decrease local temperature. The bladder catheter will be removed 15 days after patient discharge. Regarding the REZUM, it is a system that uses sterile single-use handpieces available within the company, where a special optics is inserted for direct visualization. The handpiece features a device that allows the manual insertion of a needle into the prostate, from which water vapor is emitted for the described treatment. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- PSA levels under 4 ng/ml (if PSA is over 4 ng/ml, a multiparametric prostate magnetic resonance will be performed; if a lesion with a PIRADS score over 2 is detected, a prostate biopsy will be conducted);
- Post void residual (PVR) over 50 ml;
- Maximum flow (Qmax) under 15 ml/s;
- IPSS score over 7;
- The possibility of undergoing transrectal ultrasound to assess the size of the prostate and prostate adenoma;
Key exclusion criteria (5 listed)
- Diabetes;
- Overactive or Underachieve bladder;
- Contraindications for performing MRI or prostate biopsy in cases where PSA is over 4 ng/ml;
- Intolerance to transrectal ultrasound;
- Intolerance or allergy to local anesthetics.
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 |
|---|---|---|
| Transperineal laser AblationAlso: EchoLaser EVOTreatments are performed with the combined EchoLaser EVO system (Elesta SpA - Calenzano, FI). The EchoLaser EVO consists of the Echolaser X4, a multi-source laser system with a wavelength of 1064 nm, and the Echolaser Smart Interface (ESI). The procedure are performed with the patient in the lithotomy position. Local anesthesia of the perineal region and periprostatic block with lidocaine is administered under ultrasound guidance. A catheter is placed during the irradiation to allow continuous irrigation of the urethra with saline solution, protecting the urethra from temperature rise. The Echolaser Smart Interface, defines: the number and positioning of fibers, the optimal dose, and the need for multiple pullbacks. 2 to 4 21G needles are inserted simultaneously (1 or 2 per lobe) in the peri-urethral area via transperineal ultrasound guidance. A 300-micron optical fiber will be placed in each needle. Each treatment delivers a maximum energy of 1800 J per fiber with a power of 3-5 W. | Procedure or surgery | Transperineal Laser Ablation |
| Rezum Vapor TherapyThe treatment involves the insertion of a radiofrequency needle into the prostate tissue and the emission of water vapor. Treatment under local anesthesia/sedation. Treatment planning using the REZUM device, with the number of injections proportional to the recommended therapeutic scheme based on prostate volume (1 injection every centimeter starting 1 cm below the bladder neck and 1 cm in front of the verumontanum). Water vapor emission for 9-second intervals with a maximum of 9 applications per patient. Three-way bladder catheter to decrease local temperature. The bladder catheter will be removed 15 days after patient discharge. Regarding the REZUM, it is a system that uses sterile single-use handpieces available within the company, where a special optics is inserted for direct visualization. The handpiece features a device that allows the manual insertion of a needle into the prostate, from which water vapor is emitted for the described treatment. | Procedure or surgery | Rezum Vapor Therapy |
Primary outcome
Improvement of Urodynamics parameters after 3 and 12 Months of Follow up
Time frame: up to 12 months
After 3,6 and 12 months of follow-up, uroflowmetry will be conducted to assess improvements in urinary maximum flow (Qmax: ml/sec) and average flow (Qmed: ml/sec). Milliliters and seconds will be combined to calculate and report Qmax and Qmed.
Improvement in post voided residual
Time frame: up to 12 months
After 3,6 and 12 months of follow-up, uroflowmetry will be conducted to assess improvements post voided residual (PVR: ml). Milliliters will be used to report PVR.
Improvement in International Prostate Symptoms Score
Time frame: up to 12 months
After 3,6 and 12 months of follow-up International Prostate Symptom Score (IPSS) questionnaire will be administered to all participants to evaluate changes in subjective symptoms and quality of life (Lower IPSS values indicate an improvement in the symptoms reported by the patient). The IPSS ranges from 0 to 35, with scores interpreted as follows: 0-7 indicates mild symptoms, 8-19 indicates moderate symptoms, and 20-35 indicates severe symptoms.
4 secondary outcomes
Postoperative complications
Time frame: up to 3 months
Prostate Specific Antigen (PSA) value
Time frame: up to 12 months
sexual outcomes
Time frame: up to 12 months
sexual outcomes
Time frame: up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Background: PubMed 35528781van Riel LAMJG, van Kollenburg RAA, Vis AN, van Leeuwen PJ, de Reijke TM, de Bruin DM, Oddens JR. Safety and Feasibility of Soractelite Transperineal Focal Laser Ablation for Prostate Cancer and Short-term Quality of Life Analysis from a Multicenter Pilot Study. Eur Urol Open Sci. 2022 Apr 2;39:48-54. doi: 10.1016/j.euros.2022.02.012. eCollection 2022 May.
- Background: PubMed 29122620McVary KT, Roehrborn CG. Three-Year Outcomes of the Prospective, Randomized Controlled Rezum System Study: Convective Radiofrequency Thermal Therapy for Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia. Urology. 2018 Jan;111:1-9. doi: 10.1016/j.urology.2017.10.023. Epub 2017 Nov 6.
- Background: PubMed 28474112Patelli G, Ranieri A, Paganelli A, Mauri G, Pacella CM. Transperineal Laser Ablation for Percutaneous Treatment of Benign Prostatic Hyperplasia: A Feasibility Study. Cardiovasc Intervent Radiol. 2017 Sep;40(9):1440-1446. doi: 10.1007/s00270-017-1662-9. Epub 2017 May 4.
- Background: PubMed 31827239Pacella CM, Patelli G, Iapicca G, Manenti G, Perretta T, Ryan CP, Esposito R, Mauri G. Transperineal laser ablation for percutaneous treatment of benign prostatic hyperplasia: a feasibility study. Results at 6 and 12 months from a retrospective multi-centric study. Prostate Cancer Prostatic Dis. 2020 Jun;23(2):356-363. doi: 10.1038/s41391-019-0196-4. Epub 2019 Dec 11.
- Related InfoLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Alessandro Zucchi, Professor study chair
University of Pisa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transperineal laser Ablation and Rezum Vapor Therapy in people with Benign Prostatic Hyperplasia, run by University of Pisa at 1 site in Italy.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 27 Jan 2025. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of Urodynamics parameters after 3 and 12 Months of Follow up (time frame: up to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06794333, which also lists 4 linked publications.
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 27 Jan 2025.