Benign Prostatic Hyperplasia (BPH)ECHOLASERNCT07016620
Laser Ablation a Salvage Treatment for Obstructive Benign Prostatic Hyperplasia
An observational study of Benign Prostatic Hyperplasia (BPH), run by The Cleveland Clinic at 1 site in United States.
Trial summary
Benign prostatic hyperplasia (BPH) is a common condition affecting aging men, often leading to lower urinary tract symptoms (LUTS). While Minimally Invasive Surgical Therapies (MIST) procedures offer less invasive alternatives to traditional surgery, some patients experience symptom recurrence or require further… Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia (BPH)
- What is being tested?
- Transperineal Laser Ablation (TPLA)
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2026to 1 Sep 2027
- Phase
- Observational
- 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 40 years and older
- Men only
- Adult, Older adult
Study population: Benign Prostatic Hyperplasia (BPH) salvage therapy patients
Who may be able to join
- Men > 40 years old
- History of Minimally invasive BPH procedure within the last 5 years.
- IPSS >= 12
- Prostate Volume 30 - 80 gr as assessed by CT, MRI or TRUS.
- PSA <4 or for patients with PSA 4-10 evaluation has been performed to rule out prostate cancer using biopsy, MRI, biomarker, or surgeon judgement. Labs within 1 year of study initiation
- PVR > 150cc or reduced flow on uroflow likely due to obstruction based on clinical judgement
- IIEF-6>or =10 without medication
Who cannot join
- Indwelling catheter or intermittent catheterization
- History of urethral strictures
- Previous diagnosis of Prostate cancer
- Active UTI or prostatitis
- Hypoactive detrusor function
- Neurogenic bladder (secondary to stroke, Multiple Sclerosis, Parkinson's disease, Spinal cord injury)
Show all 11Show fewer
- Ejaculatory dysfunction (retrograde ejaculation, anorgasmia or anejaculation)
- Prior traditional BPH surgery (TURP, PVP, Aquablation, HOLEP, SP)
- Presence of obstructive median lobe
- Moderate to severe or severe ED based on IIEF-6/SHIM (SHIM of 10)
- Peyronie's disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Petar Bajic, MD, 216-444-1231, bajicp@ccf.org
Raevti Bole, MD, 216 445-8640, boler@ccf.org
About this study
Official title: In-Office Transperineal Laser Ablation (TPLA) as a Salvage Treatment for Obstructive Benign Prostatic Hyperplasia (BPH) After Minimally Invasive Surgical Therapies (MIST)
Benign prostatic hyperplasia (BPH) is a common condition affecting aging men, often leading to lower urinary tract symptoms (LUTS). While Minimally Invasive Surgical Therapies (MIST) procedures offer less invasive alternatives to traditional surgery, some patients experience symptom recurrence or require further intervention due to lack of adequate relief of obstruction. Treatment of persistent obstruction after MIST therapy (BPH salvage therapy) typically requires surgical intervention like transurethral resection of prostate (TURP). This study proposes to evaluate the effectiveness of in-office transperineal laser ablation (TPLA) using the Echolaser system as a minimally invasive treatment option for these patients, potentially avoiding more invasive surgical procedures. The Cleveland Clinic sees a high volume of BPH salvage patients, making this an ideal setting for this research.
Read the detailed description
TPLA of the prostate represents a promising minimally invasive treatment modality for men experiencing LUTS secondary to BPH. This technique offers a potentially attractive alternative to traditional surgical interventions, particularly given the growing interest in less invasive procedures. The current literature focuses on evaluating the effectiveness of TPLA in improving urodynamic parameters (specifically maximum urinary flow rate (Qmax) and post-void residual volume (PVR), alleviating LUTS, and preserving sexual and ejaculatory function, as well as surgical complications.
In a recent systematic review, which included 6 studies, studies consistently reported statistically significant improvements from baseline in Qmax, PVR, and IPSS scores (International Prostate Symptom Score) at all measured time points. Furthermore, three of the studies demonstrated that TPLA did not negatively impact sexual function, showing no significant changes in IIEF-6 scores (International Index of Erectile Function) and, in some cases, statistically significant improvements in MSHQ-EjD scores (Male Sexual Health Questionnaire) at various follow-up intervals, Low complication rates were observed across all studies. Pooled analysis of the available data revealed clinically meaningful improvements in both voiding and sexual function outcomes at 1-, 3-, and 6-, and 12-months post-treatment, when compared to baseline values.
While the preliminary findings from these pilot studies suggest that TPLA may be a valuable treatment option for BPH, further research is warranted. Specifically, there is a lack of data demonstrating the efficacy of TPLA as a salvage option, where other MIST options failed.
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Being tested
- Transperineal Laser Ablation (TPLA)
- Keywords
- benign prostatic hyperplasia (BPH), lower urinary tract symptoms (LUTS), transperineal Laser Ablation (TPLA), Minimally Invasive Surgical Therapies (MIST), salvage treatment
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transperineal Laser Ablation (TPLA)Procedure or surgery
Outpatient treatment with Transperineal Laser Ablation (TPLA) as a salvage therapy after previous Minimally Invasive Surgical Therapies (MIST)
| Study group | Role | What they receive |
|---|---|---|
| Transperineal Laser Ablation (TPLA) | Patients with recurrent Benign Prostatic Hyperplasia (BPH) after Minimally Invasive Surgical Therapies previous (MIST) Receives: Procedure: Transperineal Laser Ablation (TPLA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the impact of in-office TPLA on voiding function in patients with recurrent BPH after prior MIST procedures
Change in Urinary Function as measured with IPSS score, Uroflow variables (Qmax) and Post void residue (PVR)
Measured: baseline, and then 1-, 3-, 6- and 12-months post-treatment with laser ablation
Secondary outcomes (1)
Evaluate the effect of TPLA on erectile function & ejaculatory functions in this patient population
Change in Sexual function as measured by IIEF 6, MSHQ-EjD
Measured: baseline, and then 1-, 3-, 6- and 12-months post-treatment with laser ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start12 Jan 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
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 Hyperplasia (BPH)Studies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Rocamed Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016620
- Sponsor's protocol ID
- 25-327
- Acronym
- ECHOLASER
- Status last verified
- Oct 2026
- First submitted
- 8 Apr 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sessa F, Bisegna C, Polverino P, Gacci M, Siena G, Cocci A, Li Marzi V, Minervini A, Serni S, Campi R. Transperineal laser ablation of the prostate (TPLA) for selected patients with lower urinary tract symptoms due to benign prostatic obstruction: a step-by-step guide. Urol Video J. 2022;15:100167. doi:10.1016/j.urolvj.2022.100167.
Tafuri A, Panunzio A, De Carlo F, Luperto E, Di Cosmo F, Cavaliere A, Rizzo M, Tian Z, Shakir A, De Mitri R, Porcaro AB, Cerruto MA, Antonelli A, Cormio L, Carrieri G, Karakiewicz PI, Abreu AL, Pagliarulo V. Transperineal Laser Ablation for Benign Prostatic Enlargement: A Systematic Review and Pooled Analysis of Pilot Studies. J Clin Med. 2023 Feb 26;12(5):1860. doi: 10.3390/jcm12051860.
PubMed 36902647de Rienzo G, Lorusso A, Minafra P, Zingarelli M, Papapicco G, Lucarelli G, Battaglia M, Ditonno P. Transperineal interstitial laser ablation of the prostate, a novel option for minimally invasive treatment of benign prostatic obstruction. Eur Urol. 2021 Jul;80(1):95-103. doi: 10.1016/j.eururo.2020.08.018. Epub 2020 Aug 28.
PubMed 32868137Manenti G, Perretta T, Calcagni A, Ferrari D, Ryan CP, Fraioli F, Meucci R, Malizia A, Iacovelli V, Agro EF, Floris R. 3-T MRI and clinical validation of ultrasound-guided transperineal laser ablation of benign prostatic hyperplasia. Eur Radiol Exp. 2021 Sep 17;5(1):41. doi: 10.1186/s41747-021-00239-9.
PubMed 34532768
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-Office Transperineal Laser Ablation (TPLA) as a Salvage Treatment for Obstructive Benign Prostatic Hyperplasia (BPH) After Minimally Invasive Surgical Therapies (MIST)
- ClinicalTrials.gov ID
- NCT07016620
- Acronym / sponsor ID
- ECHOLASER / 25-327
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Keywords
- benign prostatic hyperplasia (BPH), lower urinary tract symptoms (LUTS), transperineal Laser Ablation (TPLA), Minimally Invasive Surgical Therapies (MIST), salvage treatment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Rocamed Inc
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 11 Jun 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.
Benign prostatic hyperplasia (BPH) is a common condition affecting aging men, often leading to lower urinary tract symptoms (LUTS). While Minimally Invasive Surgical Therapies (MIST) procedures offer less invasive alternatives to traditional surgery, some patients experience symptom recurrence or require further intervention due to lack of adequate relief of obstruction. Treatment of persistent obstruction after MIST therapy (BPH salvage therapy) typically requires surgical intervention like transurethral resection of prostate (TURP). This study proposes to evaluate the effectiveness of in-office transperineal laser ablation (TPLA) using the Echolaser system as a minimally invasive treatment option for these patients, potentially avoiding more invasive surgical procedures. The Cleveland Clinic sees a high volume of BPH salvage patients, making this an ideal setting for this research.
Detailed description
TPLA of the prostate represents a promising minimally invasive treatment modality for men experiencing LUTS secondary to BPH. This technique offers a potentially attractive alternative to traditional surgical interventions, particularly given the growing interest in less invasive procedures. The current literature focuses on evaluating the effectiveness of TPLA in improving urodynamic parameters (specifically maximum urinary flow rate (Qmax) and post-void residual volume (PVR), alleviating LUTS, and preserving sexual and ejaculatory function, as well as surgical complications.
In a recent systematic review, which included 6 studies, studies consistently reported statistically significant improvements from baseline in Qmax, PVR, and IPSS scores (International Prostate Symptom Score) at all measured time points. Furthermore, three of the studies demonstrated that TPLA did not negatively impact sexual function, showing no significant changes in IIEF-6 scores (International Index of Erectile Function) and, in some cases, statistically significant improvements in MSHQ-EjD scores (Male Sexual Health Questionnaire) at various follow-up intervals, Low complication rates were observed across all studies. Pooled analysis of the available data revealed clinically meaningful improvements in both voiding and sexual function outcomes at 1-, 3-, and 6-, and 12-months post-treatment, when compared to baseline values.
While the preliminary findings from these pilot studies suggest that TPLA may be a valuable treatment option for BPH, further research is warranted. Specifically, there is a lack of data demonstrating the efficacy of TPLA as a salvage option, where other MIST options failed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transperineal Laser Ablation (TPLA) | – | Procedure: Transperineal Laser Ablation (TPLA)Patients with recurrent Benign Prostatic Hyperplasia (BPH) after Minimally Invasive Surgical Therapies previous (MIST) |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- Benign Prostatic Hyperplasia (BPH) salvage therapy patients
Key inclusion criteria (7 listed)
- Men > 40 years old
- History of Minimally invasive BPH procedure within the last 5 years.
- IPSS >= 12
- Prostate Volume 30 - 80 gr as assessed by CT, MRI or TRUS.
- PSA <4 or for patients with PSA 4-10 evaluation has been performed to rule out prostate cancer using biopsy, MRI, biomarker, or surgeon judgement. Labs within 1 year of study initiation
Key exclusion criteria (11 listed)
- Indwelling catheter or intermittent catheterization
- History of urethral strictures
- Previous diagnosis of Prostate cancer
- Active UTI or prostatitis
- Hypoactive detrusor function
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 Ablation (TPLA)Outpatient treatment with Transperineal Laser Ablation (TPLA) as a salvage therapy after previous Minimally Invasive Surgical Therapies (MIST) | Procedure or surgery | Transperineal Laser Ablation (TPLA) |
Primary outcome
Evaluate the impact of in-office TPLA on voiding function in patients with recurrent BPH after prior MIST procedures
Time frame: baseline, and then 1-, 3-, 6- and 12-months post-treatment with laser ablation
Change in Urinary Function as measured with IPSS score, Uroflow variables (Qmax) and Post void residue (PVR)
1 secondary outcome
Evaluate the effect of TPLA on erectile function & ejaculatory functions in this patient population
Time frame: baseline, and then 1-, 3-, 6- and 12-months post-treatment with laser ablation
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 13 Oct 2026.
- BackgroundSessa F, Bisegna C, Polverino P, Gacci M, Siena G, Cocci A, Li Marzi V, Minervini A, Serni S, Campi R. Transperineal laser ablation of the prostate (TPLA) for selected patients with lower urinary tract symptoms due to benign prostatic obstruction: a step-by-step guide. Urol Video J. 2022;15:100167. doi:10.1016/j.urolvj.2022.100167.
- Results publication: PubMed 36902647Tafuri A, Panunzio A, De Carlo F, Luperto E, Di Cosmo F, Cavaliere A, Rizzo M, Tian Z, Shakir A, De Mitri R, Porcaro AB, Cerruto MA, Antonelli A, Cormio L, Carrieri G, Karakiewicz PI, Abreu AL, Pagliarulo V. Transperineal Laser Ablation for Benign Prostatic Enlargement: A Systematic Review and Pooled Analysis of Pilot Studies. J Clin Med. 2023 Feb 26;12(5):1860. doi: 10.3390/jcm12051860.
- Results publication: PubMed 32868137de Rienzo G, Lorusso A, Minafra P, Zingarelli M, Papapicco G, Lucarelli G, Battaglia M, Ditonno P. Transperineal interstitial laser ablation of the prostate, a novel option for minimally invasive treatment of benign prostatic obstruction. Eur Urol. 2021 Jul;80(1):95-103. doi: 10.1016/j.eururo.2020.08.018. Epub 2020 Aug 28.
- Results publication: PubMed 34532768Manenti G, Perretta T, Calcagni A, Ferrari D, Ryan CP, Fraioli F, Meucci R, Malizia A, Iacovelli V, Agro EF, Floris R. 3-T MRI and clinical validation of ultrasound-guided transperineal laser ablation of benign prostatic hyperplasia. Eur Radiol Exp. 2021 Sep 17;5(1):41. doi: 10.1186/s41747-021-00239-9.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Benign Prostatic Hyperplasia (BPH), run by The Cleveland Clinic at 1 site in United States.
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 7 inclusion and 11 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 13 Oct 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 United States. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the impact of in-office TPLA on voiding function in patients with recurrent BPH after prior MIST procedures (time frame: baseline, and then 1-, 3-, 6- and 12-months post-treatment with laser ablation). 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 NCT07016620, 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 13 Oct 2026.