[Minimally invasive treatment of benign prostatic hyperplasia : The German S2e guideline 2023-part 4]. / Minimalinvasive Therapien des benignen Prostatasyndroms : Die deutsche S2e-Leitlinie 2023 ­ Teil 4/4.

BACKGROUND: Lower urinary tract symptoms suggestive for benign prostatic obstruction (LUTS/BPO) are one of the most frequent diseases in men and can have a significant impact on quality of life. Instrumental therapies are common, and many patients seek minimally invasive treatment options. OBJECTIVE: Presentation and evidence-based evaluation of the minimally invasive therapy for benign prostatic syndrome. MATERIALS AND METHODS: Summary and overview of chapters 11-13 on minimally invasive therapies for LUTS/BPO of the current long version of the German S2e guideline. RESULTS: In case of absolute indication for surgery or after unsatisfactory or undesired medical therapy, minimally invasive treatments such as UroLift® (Neotract Inc., Pleasanton, CA, USA), Rezá¿¡m™ (Boston Scientific, Malborough, MA, USA), iTIND™ (Olympus America Inc., Westborough, MA, USA), and prostatic artery embolization (PAE) can be considered. These indirect/delayed ablative therapies offer lower morbidity and the possibility of performing them under local anesthesia, but they are inferior to direct ablative/resective techniques in terms of effectiveness and sustainability. CONCLUSIONS: The updated German S2e guideline summarizes evidence-based recommendations for new minimally invasive therapies for LUTS/BPO, which present alternative treatment options for selected patients.

Minimally Invasive Therapies for Benign Prostatic Obstruction: A Review of Currently Available Techniques Including Prostatic Artery Embolization, Water Vapor Thermal Therapy, Prostatic Urethral Lift, Temporary Implantable Nitinol Device and Aquablation.

A 66-years old male patient presents with lower urinary tract symptoms, mostly due to obstructive symptoms, and an enlarged prostate with 80 cm3, with a broad-based median lobe, suggestive of benign prostatic obstruction (BPO). Trans-urethral resection of the prostate (TURP) was proposed. However, the patient desired to preserve ejaculatory function and was afraid of a potential negative impact on erectile function. Thus, the patient inquired about minimally invasive therapies (MITs) as alternatives to TURP. In this review, currently available MITs for BPO are described including prostatic artery embolization, water vapor thermal therapy (Rezum®), prostatic urethral lift, iTIND® (temporary implantable device) and aquablation (Aquabeam®). Focus is given on the description of the technique, level of evidence and advantages over conventional surgical options.

New Endoscopic In-office Surgical Therapies for Benign Prostatic Hyperplasia: A Systematic Review.

CONTEXT: In recent years, new technologies have been developed to treat benign prostatic enlargement (BPE). Three of these devices may be utilized in office and are promising additions. OBJECTIVE: To systematically review all clinical trials investigating prostatic urethral lift (PUL), water vapor thermal therapy (WVTT), and temporary implantable nitinol device (TIND), with emphasis on clinical efficacy and complications. EVIDENCE ACQUISITION: We performed a systematic review of PubMed/Medline database in November 2020 according to Preferred Reporting Items for Systematic Review and Meta-analysis guidelines. EVIDENCE SYNTHESIS: Of 168 articles identified, 18 met the inclusion criteria. Evidence consisted of few randomized controlled trials, and multiple single-arm prospective and retrospective studies. Among the three modalities, PUL demonstrates rare occurrence of serious complications but higher retreatment rates at short- and long-term follow-up. WVTT offers lower retreatment rates with a similar safety profile. TIND studies report varying rates of retreatment and complications. All technologies offer low rates of erectile and ejaculatory dysfunction, although the risk appears to be highest for WVTT (<10.8%). CONCLUSIONS: Among the emerging technologies introduced to treat BPE, the in-office PUL, WVTT, and TIND systems are valuable additions to the current surgical options. These systems offer unique advantages that should be considered in the shared decision-making process. PATIENT SUMMARY: In this report, we identified all clinical trials reporting on the efficacy and safety of the in-office prostatic urethral lift (PUL), water vapor thermal therapy (WVTT), and temporary implantable nitinol device (TIND) systems for the treatment of benign prostatic enlargement. We found that PUL and WVTT demonstrate acceptable outcomes in terms of functional improvement, retreatment, and complications. More data with longer follow-up are required to further evaluate TIND, but early results are promising.

Are all procedures for benign prostatic hyperplasia created equal? A systematic review on post-procedural PSA dynamics and its correlation with relief of bladder outlet obstruction.

PURPOSE: To evaluate and provide a comprehensive literature review of Prostate specific antigen (PSA) dynamics after various surgical procedures for benign prostatic hyperplasia (BPH). METHODS: A thorough PubMed database search was performed over last 30 years including terms "PSA" and various surgical procedures for BPH. PSA nadir after various procedure was evaluated. The post-operative improvement in International Prostate Symptom Score, maximum void rates and post-void residue after surgeries were recorded. An indirect correlation was made between PSA nadir and outcome of various BPH surgical procedures. RESULTS: Enucleation procedures like simple prostatectomy and endoscopic enucleation of prostate (EEP) produced maximum drop in PSA level after surgery and were associated with the highest improvement in post-operative parameters. The PSA nadir following resection techniques like transurethral resection of prostate and Holmium laser resection of prostate and vaporization technique was variable and less robust when compared to EEP. Newer techniques like Aquablation, Rezum, Urolift, Prostate artery embolization and Temporary implantable nitinol devices (iTIND) produce relatively less reduction in PSA and lesser percentile improvement in post-operative parameters. CONCLUSIONS: Various surgical procedures for BPH result in varying PSA nadirs level. Enucleation procedures and simple prostatectomy produce the most drastic and sustained decrease in PSA. There is a possible indirect evidence suggesting that the level of PSA nadir corresponds closely with the degree of post-operative improvement and durability of the procedure. Establishing the new PSA nadir at 3-6 months after the procedure is recommended as a part of routine surveillance for prostate cancer in eligible patients.

Modern advancements in minimally invasive surgical treatments for benign prostatic obstruction.

A wide variety of minimally invasive surgical techniques are now being offered for treating voiding lower urinary tract symptoms (LUTS) secondary to benign prostatic obstruction (BPO). These options offer an alternative to both medical therapy and traditional surgical options. Minimally invasive surgical treatments in LUTS/BPO boast both day case and local anaesthetic options, with a potentially reduced side effect profile compared to traditional surgical interventions matching the needs for a range of patients. We provide a narrative review of minimally invasive surgical treatments available for BPO in terms of the technology, efficacy, safety, institutional recommendations, cost and potential future developments.

Urinary and sexual function after treatment with temporary implantable nitinol device (iTind) in men with LUTS: 6-month interim results of the MT-06-study.

PURPOSE: To evaluate the functional outcomes as they relate to the preservation of urinary continence and sexual function after treatment with the temporarily implanted nitinol device (iTind; Medi-Tate Ltd, Israel); a novel minimally invasive treatment for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). METHODS: Men with symptomatic BPH (IPSS ≥ 10, Qmax < 12 ml/s, and prostate volume (PV) < 120 ml) were invited to participate in this single-arm, prospective multicenter study (MT06). Patients were not washed out of BPH medications before the procedure. The iTind was implanted through a 22F rigid cystoscope under intravenous sedation and was removed 5-7 days later through a 22F Foley catheter under local anesthesia. Post-operative VAS and complications (Clavien Dindo-Grading System) were recorded. Preservation of urinary continence and erectile and ejaculatory function were assessed according to ISI, MSHQ-EjD and SHIM questionnaires. Post-operative IPSS, QoL, Qmax and PVR were also assessed at 1, 3, and 6 months post-operatively. RESULTS: This interim report includes data out to 6 months on the first 70 patients enrolled in the study. The median age was 62.31 years, and the mean prostate volume was 37.68 ml (15-80 ml). Baseline and follow-up data are reported in Table 1. No intraoperative complications were observed, the average post-operative VAS score was 3.24 ± 2.56. On average patients returned to daily life after 4.3 days following the retrieval procedure. Sexual function and urinary continence were preserved in all subjects according to the ISI, SHIM and MSHQ-EjD questionnaires and significant improvements (p < 0.0001) from baseline levels were recorded in IPSS, QoL and peak flow. CONCLUSION: iTind is a well-tolerated, minimally invasive treatment for BPH-related LUTS which preserves sexual function and urinary continence, offers a rapid recovery and return to daily life, and a significant improvement of symptoms and urinary flow at 6-month follow-up.

[An update on the most recent mini-invasive surgical and interventional techniques in the management of benign prostatic obstruction]. / Mise au point sur les nouvelles techniques chirurgicales et interventionnelles dans la prise en charge de l'obstruction sous-vésicale liée à l'hyperplasie bénigne de la prostate.

INTRODUCTION: New surgical techniques for the treatment of benign prostatic obstruction (BPO) have emerged in recent years. We sought to give an overview on each of these technologies. MATERIAL: A comprehensive review of the literature between 2013 and 2020 was carried out by a panel of national experts already practicing these interventions. All the data were then discussed among all the co-authors in order to obtain a consensus with regard to the selected articles and their analysis. Finally, an inventory was drawn to provide an overview of these technological advances and their availability in France. RESULTS: The treatment benign prostatic obstruction has diversified greatly over the past 5 years. 5 new technologies have emerged, allowing today a transurethral non-ablative treatment (UROLIFT®, ITIND®), a transurethral ablative treatment (REZUM®), a transurethral ablative treatment with robotic assistance (AQUABEAM®) or an endovascular management by embolization of the prostatic arteries. Only UROLIFT® is considered an established technology in the latest EAU-Guidelines. The other four are under evaluation and recommendations have only been issued for two of them, AQUABEAM® and the embolization of the prostatic arteries. CONCLUSION: These new minimally invasive techniques aim to increase the therapeutic options for the management of BPO in order to offer a management more suited to the wishes of the patient. Some are positioned as an alternative to surgical or medical treatment, others between medical and surgical treatment. These technologies are not all at the same level of development, evaluation and level of proof, but have in common a limited distribution in France, in particular given their cost. Validated studies will allow them to position their subsequent use more precisely.

iTIND: the second-generation temporary implantable nitinol device for minimally invasive treatment of benign prostatic hyperplasia.

iTIND is the second-generation version of the temporary nitinol implantable device (TIND), which has emerged over the past decade as one of the latest additions to the library of minimally invasive surgeries now available to treat bothersome lower urinary tract symptoms (LUTS) caused by benign prostate enlargement. While the key procedural steps remain the same, it now carries specific modifications designed to improve its efficacy and safety profile further. With the option to perform implantation under local anaesthesia, it can be delivered on an ambulatory basis and in the office setting. While the formal position of iTIND in current guidelines is yet to be determined, 12-month data demonstrates that it can improve both objective and subjective outcome measures, which are sustained at short-term follow up.

Second generation of temporary implantable nitinol device (iTind) in men with LUTS: 2 year results of the MT-02-study.

OBJECTIVES: Assessing medium-term functional results of a novel minimally-invasive treatment for lower urinary tract symptoms due to BPO with the second generation of the temporary implantable nitinol device (iTind; Medi-Tate Ltd®, Israel): 2-year follow-up of a single-arm, prospective, international multicenter study. Further, we aimed to identify preoperative baseline parameters predicting response to iTind treatment. METHODS: Following local ethical committee approval in every participating centre, 81 men with symptomatic BPO (IPSS ≥ 10, peak urinary flow < 12 ml/s, and prostate volume < 75 ml) were enrolled in this study. Patients with PVR > 250 ml, obstructive median lobe, previous prostatic surgery, confounding bladder or sphincter dysfunction based on medical history, active urinary infection and unable to interrupt antithrombotic or antiplatelet treatment were exclusion criteria. A wash-out period of 1 month for alpha-blockers and 6 months for 5-ARIs was mandatory to avoid confounders. The procedure was performed as previously described: implantation under light sedation and removal 5-7 days later with topical sedation. Patients were assessed for perioperative results including OR-time, pain (VAS) and complications (Clavien-Dindo-Grading System); and for functional results (PVR, Qmax, IPSS) and quality of life (QoL) including sexual and ejaculatory function using two yes/no questions. Follow-up assessments were done at 1, 3, and 6 months, and 1 and 2 years. RESULTS: Of the 81 patients initially enrolled in this study, follow-up included 67 men at 1 year and 51 men at 2 years. For the 51 men included in the present analysis, the median age was 65 years, median prostate volume 37 ml (range 16-65 ml). Baseline values for IPSS and QoL were 20.51 ± 4.58, 3.96 ± 0.87. Qmax and PVR were 7.62 ± 2.25 ml/s and 65.84 ± 38.46, respectively. No intraoperative complications were observed and the average pain level recorded on the visual analogue scale (VAS) was 3.2 ± 1.6. A significant reduction in symptoms and improvement in urinary flow was observed (p < 0.0001) at all assessment points: IPSS-score and QoL improved to 8.51 ± 5.51 and 1.76 ± 1.32, respectively; and Qmax increased to 16.00 ± 7.43 ml/s. None of the patients who were previously sexually active reported a deterioration in sexual or ejaculatory functions according to two yes/no questions over the follow-up period. Excluding the patients lost at follow-up, five patients underwent surgery between 12 and 24 months. Upon investigation, it was discovered that four of the five patients requiring surgery had median lobes and were protocol deviators. A failure analysis was carried out for all 81 patients in order to identify baseline parameters that could predict treatment failure. 58.33% of patients in the failure group (7 out of 12) had median lobes which was found to be statistically significant (p < 0.0001). None of the other preoperative variables (age, prostate volume, IPSS scores, Qmax, PVR, and PSA) were found to predict response to iTind treatment. CONCLUSION: iTind treatment for BPO-related LUTS showed marked and durable reduction in symptoms and improvement of functional parameters and quality of life at 24 months of follow-up. It was found that median lobe may predict failure of iTind treatment. According to the yes/no questions, ejaculatory and sexual functions do not seem to be effected following treatment, however, this finding must be supported with further studies using the accepted tools.

First- and Second-Generation Temporary Implantable Nitinol Devices As Minimally Invasive Treatments for BPH-Related LUTS: Systematic Review of the Literature.

INTRODUCTION: In the last decade, there has been a growing interest in minimally invasive treatment for benign prostatic hyperplasia (BPH) associated with lower urinary tract symptoms (LUTS). In this field, one of the options currently available is the temporary implantable nitinol device (iTIND) (Medi-Tate®; Medi-Tate Ltd., Or Akiva, Israel). PURPOSE OF THE WORK: To review the recent data available in the literature regarding the role of the first-generation (TIND) and second-generation (iTIND) devices for the management of BPH with LUTS, especially focusing on follow-up of functional outcomes. EVIDENCE ACQUISITION: PubMed, Embase, and the Cochrane Central Register of Controlled Trials were screened for clinical trials on this topic. EVIDENCE SYNTHESIS: Literature evidences regarding implantation of TIND and iTIND for PBH with LUTS are limited. There are only three studies available, one with a medium-term follow-up. The results of these studies suggested that both the TIND and iTIND implantations are safe, effective, and well-tolerated procedures, allowing spare ejaculation in sexually active patients. CONCLUSIONS: Current evidences emphasize that the temporary implantable nitinol devices are promising alternatives to the standard minimally invasive surgical options for BPH-related LUTS. Further studies are needed to confirm the effectiveness over a long-term follow-up.

Second-generation of temporary implantable nitinol device for the relief of lower urinary tract symptoms due to benign prostatic hyperplasia: results of a prospective, multicentre study at 1 year of follow-up.

OBJECTIVES: To report the clinical experience with a second-generation of temporary implantable nitinol device (iTIND; Medi-Tate Ltd, Or-Akiva, Israel) for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) after 1 year of follow-up. PATIENTS AND METHODS: In all, 81 patients with LUTS, International Prostate Symptom Score (IPSS) ≥10, maximum urinary flow rate (Qmax ) ≤12 mL/s, and prostate volume <75 mL, were enrolled in this prospective Research Ethics Committee-approved multicentre study. The main exclusion criteria were: haemostatic disorders, post-void residual urine volume (PVR) >250 mL, obstructive median lobe, and previous prostate surgery. The iTIND was implanted within the bladder neck and the prostatic urethra under light sedation, using a rigid cystoscope. The device was removed 5-7 days later in an outpatient setting. Demographics, perioperative results, complications (according to the Clavien-Dindo system), functional results and quality of life (QoL) were evaluated. Follow-up assessments were conducted at 1, 3, 6 and 12 months postoperatively. RESULTS: The mean (sd) patient age was 65 (8.9) years, prostate volume was 40.5 (12.25) mL, Qmax was 7.3 (2.6) mL/s, IPSS was 22.5 (5.6), and the median (interquartile range) IPSS QoL score was 4 (2-5). All the implantations were successful, with no intraoperative complications recorded; all patients were discharged on the same day of surgery. The devices were retrieved at a mean (SD) of 5.9 (1.1) days after implantation, typically under topical anaesthesia. No Clavien-Dindo Grade >II complications were recorded. The mean (SD) Qmax at the 1 month follow-up visit was 11.2 (5.7) mL/s and continued to improve thereafter, reaching 14.7 (8.1) mL/s at the 12-month follow-up visit (+100%). The mean (SD) IPSS urinary symptom scores were 11.7 (8.0) after 1 month and further improved to 8.8 (6.4) at the 12-month follow-up (-60%). In parallel, the mean (SD) IPSS QoL score drop reached 1.6 (1.3) by the end of the study. During the 12-month period, two patients (2.4%) required medical therapy for BPH, two patients (2.4%) required transurethral resection of the prostate, whilst 10 patients were lost to follow-up (12.3%). As compared to baseline, none of the 61 sexually active patients who completed the 12-month follow-up period reported sexual or ejaculatory dysfunction. CONCLUSION: iTIND implantation is feasible, safe and effective in providing relief of BPH-related symptoms, at least until 12 months postoperatively. Sexual and ejaculatory functions are fully preserved. Further studies with a longer follow-up period are needed to assess the durability of these results and to clearly define the indications for iTIND implantation.