Benign Prostatic HyperplasiaNCT06564415
European Registry for Transperineal Laser Ablation of Prostate (TPLA) for Lower Urinary Tract Symptoms
An observational study of Benign Prostatic Hyperplasia and Prostatic Diseases, run by University of Florence at 1 site in Italy.
Trial summary
The goal of this observational study is to assess mid- and long-term effectiveness of Transperineal Laser Ablation of Prostate (TPLA) for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic obstruction measured by need and/or time until surgical retreatment. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Prostatic Diseases
- What is being tested?
- Transperineal Laser Ablation of Prostate
- Type of treatment
- Surgery or procedure
- How many people
- 2,500 participants
- Where
- 1 siteItaly
- Study dates
- 11 Jan 2024to Jan 2034
- How long will I take part?
- 5 Years
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred to the centers participating in the study
Who may be able to join
- Age ≥18 years;
- Prostate volume ≥ 30 mL;
- Moderate-to-severe LUTS according to International Prostatic Symptoms Score (IPSS ≥8)
- Consent to participate;
Who cannot join
- Absence of consent;
- Subsequent withdrawal of consent;
- Diagnosis or suspicion of prostate cancer at multiparametric magnetic resonance
- Documented bladder impaired contractility
- Urethral stenosis
- Previous prostate surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
AOU Careggi
Florence, 50134
Francesco Sessa, +39 3287305299, francesco_sessa@hotmail.it
Paolo Polverino, +39 3406039600, paolopolverino94@gmail.com
About this study
Official title: European Registry for Transperineal Laser Ablation of Prostate (TPLA) for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Obstruction (BPO)
The goal of this observational study is to assess mid- and long-term effectiveness of Transperineal Laser Ablation of Prostate (TPLA) for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic obstruction measured by need and/or time until surgical retreatment.
Data regarding patient-reported outcomes measures (PROMs), flowmetry parameters and safety about consecutive patients undergoing TPLA will be collected in a dedicated platform.
Read more
Secondary objectives of the study are:
- To assess functional and safety outcomes in patients treated with transperineal laser ablation for LUTS due to benign prostatic obstruction;
- To identify possible differences in characteristics of patients treated with transperineal laser ablation among the centers and possible relations between treatment application and outcomes, in order to explore the optimal indications and possible limitations of TPLA for LUTS.
- Conditions
- Benign Prostatic Hyperplasia, Prostatic Diseases
- Being tested
- Transperineal Laser Ablation of Prostate
- Keywords
- TPLA, Transperineal Laser Ablation, LUTS, BPH, Benign Prostatic Obstruction
- Medical subject headings
- Prostatic Hyperplasia, Prostatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transperineal Laser Ablation of ProstateProcedure or surgery
Transperineal Laser Ablation of the Prostate is an ultra minimally-invasive procedure that consists in the insertion trough the perineum skin of laser fibers into the prostatic adenoma, under US guidance. Laser energy generates an area of coagulative necrosis that will bring to a reduction of the prostatic volume.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of partecipants needing for other surgery
Mid- and long-term effectiveness of TPLA measured by need and/or time until surgical retreatment for BPO (e.g. Transurethral resection of prostate (TURP), endoscopic enucleation, simple prostatectomy)
Measured: 5 years
Secondary outcomes (9)
Number of Participants with Treatment-Related Adverse Events according to Clavien-Dindo Scale
Number of Participants with Treatment-Related Adverse Events as Assessed by Clavien-Dindo scale (score from I to V - higher scores mean a worse outcome)
Measured: 6 months
Number of Participants with Treatment-Related Adverse Events according to Comprehensive Complication Index
Number of Participants with Treatment-Related Adverse Events as Assessed by Comprehensive Complication Index. The Comprehensive Complication Index (CCI) reflects the gravity of the overall complication burden on the patient on a scale from 0 (no complication) to 100 (death)
Measured: 6 months
Change from Baseline in the International Prostatic Symptoms Score (IPSS)
Patient-reported outcome measure about urinary symptoms evaluated by International Prostatic Symptoms Score (IPSS) - values from 0 to 35 (higher scores mean a worse outcome)
Measured: 5 years
Change from Baseline in the IPSS - Quality of Life score
Patient-reported outcome measure about impact of urinary symptoms on quality of life evaluated by IPSS - Quality of Life (QoL) questionnaire (values from 0 to 6 - higher scores mean a worse outcome)
Measured: 5 years
Change from Baseline in the International Index of Erectile Function (IIEF-5)
Patient-reported outcome measure about erectile function evaluated by International Index of Erectile Function (IIEF-5) - values from 0 to 25 (higher values mean a better outcome)
Measured: 5 years
Change from Baseline in the Male Sexual Health Questionnaire bother (MSHQ bother)
Patient-reported outcome measure about impact of ejaculatory disfunctions in quality of life evaluated by Male Sexual Health Questionnaire bother (MSHQ bother) - values from 0 to 5 (higher scores mean a worse outcome)
Measured: 5 years
Change from Baseline in the Male Sexual Health Questionnaire 3-items (MSHQ 3-items)
Patient-reported outcome measure about ejaculatory function evaluated by Male Sexual Health Questionnaire 3-items (MSHQ 3-items) - values from 0 to 15 (higher scores mean a better outcome)
Measured: 5 years
Change from Baseline in maximum flow rate (ml/s)
Change from Baseline in maximum flow rate (ml/s) evaluated at uroflowmetry
Measured: 5 years
Change from Baseline in post void residual volume (ml)
Change from Baseline in post void residual volume (ml) evaluated with sovrapubic ultrasound or bladderscan after spontaneous micturition
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start11 Jan 2024
- Primary completionJan 2034 (estimated)
- Study completionJan 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Sessa, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564415
- Sponsor's protocol ID
- 25691
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
Publications
Sessa F, Polverino P, Siena G, Bisegna C, Lo Re M, Spatafora P, Pecoraro A, Rivetti A, Moscardi L, Saladino M, Cocci A, Gacci M, Li Marzi V, Carini M, Minervini A, Campi R, Serni S. Transperineal Laser Ablation of the Prostate (TPLA) for Lower Urinary Tract Symptoms Due to Benign Prostatic Obstruction. J Clin Med. 2023 Jan 19;12(3):793. doi: 10.3390/jcm12030793.
PubMed 36769454Polverino P, Lo Re M, Saladino M, Pecoraro A, Moscardi L, Rivetti A, Resta GR, Pezzoli M, Romano A, Somani BK, Siena G, Cocci A, Gacci M, Minervini A, Serni S, Campi R, Sessa F. Could transperineal interstitial laser ablation of the prostate be the right option for highly-comorbid patients with lower urinary tract symptoms due to benign prostatic obstruction? A preliminary single-center experience focusing on functional and safety outcomes. Minerva Urol Nephrol. 2024 Oct;76(5):646-649. doi: 10.23736/S2724-6051.23.05479-4. Epub 2023 Dec 13.
PubMed 38093618Lo Re M, Polverino P, Rivetti A, Pecoraro A, Saladino M, Pezzoli M, Siena G, De Nunzio C, Li Marzi V, Gacci M, Serni S, Campi R, Sessa F. Transperineal laser ablation (TPLA) of the prostate for benign prostatic obstruction: the first 100 patients cohort of a prospective, single-center study. World J Urol. 2024 Jul 10;42(1):402. doi: 10.1007/s00345-024-05077-z.
PubMed 38985193Canat HL, Gurbuz C, Bozkurt M. Transurethral resection of the prostate (TURP) versus transperineal laser ablation (TPLA) due to benign prostatic hyperplasia (BPH): prospective and comparative study. Int Urol Nephrol. 2023 Nov;55(11):2747-2752. doi: 10.1007/s11255-023-03717-8. Epub 2023 Jul 27.
PubMed 37498422Minafra P, DE Rienzo G, Gerbasi S, Cindolo L, Battaglia M, Ditonno P. Three years outcomes of transperineal laser ablation of the prostate. Minerva Urol Nephrol. 2023 Aug;75(4):471-478. doi: 10.23736/S2724-6051.23.05270-9. Epub 2023 Jun 14.
PubMed 37314812Bertolo R, Iacovelli V, Cipriani C, Carilli M, Vittori M, Antonucci M, Maiorino F, Signoretti M, Petta F, Travaglia S, Panei M, Bove P. Ejaculatory function following transperineal laser ablation vs TURP for benign prostatic obstruction: a randomized trial. BJU Int. 2023 Jul;132(1):100-108. doi: 10.1111/bju.16008. Epub 2023 Mar 30.
PubMed 36917033Patelli 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 31827239Manenti 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 34532768Frego N, Saita A, Casale P, Diana P, Contieri R, Avolio PP, Lazzeri M, Hurle R, Buffi NM, Guazzoni GF, Lughezzani G. Feasibility, safety, and efficacy of ultrasound-guided transperineal laser ablation for the treatment of benign prostatic hyperplasia: a single institutional experience. World J Urol. 2021 Oct;39(10):3867-3873. doi: 10.1007/s00345-021-03685-7. Epub 2021 Apr 3.
PubMed 33811512de 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 32868137Cai HJ, Fang JH, Kong FL, Xu CK, Chen CH, Wang W, Huang B. Ultrasound-guided transperineal laser ablation for percutaneous treatment of benign prostatic hyperplasia: a new minimally invasive interventional therapy. Acta Radiol. 2022 Apr;63(4):553-558. doi: 10.1177/02841851211003289. Epub 2021 Mar 28.
PubMed 33779301
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Registry for Transperineal Laser Ablation of Prostate (TPLA) for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Obstruction (BPO)
- ClinicalTrials.gov ID
- NCT06564415
- Acronym / sponsor ID
- 25691
- Conditions
- Benign Prostatic Hyperplasia, Prostatic Diseases
- Keywords
- TPLA, Transperineal Laser Ablation, LUTS, BPH, Benign Prostatic Obstruction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- Jan 2034 (estimated)
- Study completion
- Jan 2034 (estimated)
- First posted
- 21 Aug 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.
The goal of this observational study is to assess mid- and long-term effectiveness of Transperineal Laser Ablation of Prostate (TPLA) for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic obstruction measured by need and/or time until surgical retreatment.
Data regarding patient-reported outcomes measures (PROMs), flowmetry parameters and safety about consecutive patients undergoing TPLA will be collected in a dedicated platform.
Secondary objectives of the study are:
- To assess functional and safety outcomes in patients treated with transperineal laser ablation for LUTS due to benign prostatic obstruction;
- To identify possible differences in characteristics of patients treated with transperineal laser ablation among the centers and possible relations between treatment application and outcomes, in order to explore the optimal indications and possible limitations of TPLA for LUTS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to the centers participating in the study
Key inclusion criteria (4 listed)
- Age ≥18 years;
- Prostate volume ≥ 30 mL;
- Moderate-to-severe LUTS according to International Prostatic Symptoms Score (IPSS ≥8)
- Consent to participate;
Key exclusion criteria (6 listed)
- Absence of consent;
- Subsequent withdrawal of consent;
- Diagnosis or suspicion of prostate cancer at multiparametric magnetic resonance
- Documented bladder impaired contractility
- Urethral stenosis
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 of ProstateTransperineal Laser Ablation of the Prostate is an ultra minimally-invasive procedure that consists in the insertion trough the perineum skin of laser fibers into the prostatic adenoma, under US guidance. Laser energy generates an area of coagulative necrosis that will bring to a reduction of the prostatic volume. | Procedure or surgery | – |
Primary outcome
Rate of partecipants needing for other surgery
Time frame: 5 years
Mid- and long-term effectiveness of TPLA measured by need and/or time until surgical retreatment for BPO (e.g. Transurethral resection of prostate (TURP), endoscopic enucleation, simple prostatectomy)
9 secondary outcomes
Number of Participants with Treatment-Related Adverse Events according to Clavien-Dindo Scale
Time frame: 6 months
Number of Participants with Treatment-Related Adverse Events according to Comprehensive Complication Index
Time frame: 6 months
Change from Baseline in the International Prostatic Symptoms Score (IPSS)
Time frame: 5 years
Change from Baseline in the IPSS - Quality of Life score
Time frame: 5 years
Change from Baseline in the International Index of Erectile Function (IIEF-5)
Time frame: 5 years
Change from Baseline in the Male Sexual Health Questionnaire bother (MSHQ bother)
Time frame: 5 years
Change from Baseline in the Male Sexual Health Questionnaire 3-items (MSHQ 3-items)
Time frame: 5 years
Change from Baseline in maximum flow rate (ml/s)
Time frame: 5 years
Change from Baseline in post void residual volume (ml)
Time frame: 5 years
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 21 Aug 2024.
- Background: PubMed 36769454Sessa F, Polverino P, Siena G, Bisegna C, Lo Re M, Spatafora P, Pecoraro A, Rivetti A, Moscardi L, Saladino M, Cocci A, Gacci M, Li Marzi V, Carini M, Minervini A, Campi R, Serni S. Transperineal Laser Ablation of the Prostate (TPLA) for Lower Urinary Tract Symptoms Due to Benign Prostatic Obstruction. J Clin Med. 2023 Jan 19;12(3):793. doi: 10.3390/jcm12030793.
- Background: PubMed 38093618Polverino P, Lo Re M, Saladino M, Pecoraro A, Moscardi L, Rivetti A, Resta GR, Pezzoli M, Romano A, Somani BK, Siena G, Cocci A, Gacci M, Minervini A, Serni S, Campi R, Sessa F. Could transperineal interstitial laser ablation of the prostate be the right option for highly-comorbid patients with lower urinary tract symptoms due to benign prostatic obstruction? A preliminary single-center experience focusing on functional and safety outcomes. Minerva Urol Nephrol. 2024 Oct;76(5):646-649. doi: 10.23736/S2724-6051.23.05479-4. Epub 2023 Dec 13.
- Background: PubMed 38985193Lo Re M, Polverino P, Rivetti A, Pecoraro A, Saladino M, Pezzoli M, Siena G, De Nunzio C, Li Marzi V, Gacci M, Serni S, Campi R, Sessa F. Transperineal laser ablation (TPLA) of the prostate for benign prostatic obstruction: the first 100 patients cohort of a prospective, single-center study. World J Urol. 2024 Jul 10;42(1):402. doi: 10.1007/s00345-024-05077-z.
- Background: PubMed 37498422Canat HL, Gurbuz C, Bozkurt M. Transurethral resection of the prostate (TURP) versus transperineal laser ablation (TPLA) due to benign prostatic hyperplasia (BPH): prospective and comparative study. Int Urol Nephrol. 2023 Nov;55(11):2747-2752. doi: 10.1007/s11255-023-03717-8. Epub 2023 Jul 27.
- Background: PubMed 37314812Minafra P, DE Rienzo G, Gerbasi S, Cindolo L, Battaglia M, Ditonno P. Three years outcomes of transperineal laser ablation of the prostate. Minerva Urol Nephrol. 2023 Aug;75(4):471-478. doi: 10.23736/S2724-6051.23.05270-9. Epub 2023 Jun 14.
- Background: PubMed 36917033Bertolo R, Iacovelli V, Cipriani C, Carilli M, Vittori M, Antonucci M, Maiorino F, Signoretti M, Petta F, Travaglia S, Panei M, Bove P. Ejaculatory function following transperineal laser ablation vs TURP for benign prostatic obstruction: a randomized trial. BJU Int. 2023 Jul;132(1):100-108. doi: 10.1111/bju.16008. Epub 2023 Mar 30.
- 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.
- Background: 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.
- Background: PubMed 33811512Frego N, Saita A, Casale P, Diana P, Contieri R, Avolio PP, Lazzeri M, Hurle R, Buffi NM, Guazzoni GF, Lughezzani G. Feasibility, safety, and efficacy of ultrasound-guided transperineal laser ablation for the treatment of benign prostatic hyperplasia: a single institutional experience. World J Urol. 2021 Oct;39(10):3867-3873. doi: 10.1007/s00345-021-03685-7. Epub 2021 Apr 3.
- Background: 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.
- Background: PubMed 33779301Cai HJ, Fang JH, Kong FL, Xu CK, Chen CH, Wang W, Huang B. Ultrasound-guided transperineal laser ablation for percutaneous treatment of benign prostatic hyperplasia: a new minimally invasive interventional therapy. Acta Radiol. 2022 Apr;63(4):553-558. doi: 10.1177/02841851211003289. Epub 2021 Mar 28.
- 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 and Prostatic Diseases, run by University of Florence 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 4 inclusion and 6 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 21 Aug 2024. 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?
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 Francesco Sessa (+39 3287305299, francesco_sessa@hotmail.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of partecipants needing for other surgery (time frame: 5 years). 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 NCT06564415, which also lists 12 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 21 Aug 2024.