Clinical trial NCT07016620: Laser Ablation a Salvage Treatment for Obstructive Benign Prostatic Hyperplasia
Official title: In-Office Transperineal Laser Ablation (TPLA) as a Salvage Treatment for Obstructive Benign Prostatic Hyperplasia (BPH) After Minimally Invasive Surgical Therapies (MIST)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Rocamed Inc
First posted: 2025-06-11
Enrollment: 20
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Benign Prostatic Hyperplasia (BPH) salvage therapy patients

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* 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

Primary outcomes:
measure: Evaluate the impact of in-office TPLA on voiding function in patients with recurrent BPH after prior MIST procedures
timeFrame: baseline, and then 1-, 3-, 6- and 12-months post-treatment with laser ablation
Secondary outcomes:
measure: Evaluate the effect of TPLA on erectile function & ejaculatory functions in this patient population
timeFrame: baseline, and then 1-, 3-, 6- and 12-months post-treatment with laser ablation
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
References:
citation: 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.
citation: 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.
citation: de 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.
citation: Manenti 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.