Interventional procedure overview of prostatic urethral temporary implant insertion for lower urinary tract symptoms caused by benign prostatic hyperplasia
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Appendix
The following table outlines the studies that are considered potentially relevant to the IP overview but were not included in the summary of the key evidence. It is by no means an exhaustive list of potentially relevant studies.
Article | Number of patients/ follow up | Direction of conclusions | Reasons for non-inclusion in summary of key evidence section |
|---|---|---|---|
Amparore D, De Cillis S, Volpi G et al. (2019) First- and second-generation temporary implantable nitinol devices as minimally invasive treatments for BPH-related LUTS: systematic review of the literature. Current Urology Reports 20: 47 | Systematic review 3 studies | Current evidence suggests 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. | Only 3 studies are included, all of which are already summarised in the key evidence. |
Balakrishnan D, Jones P, Somani BK (2020) iTIND: the second-generation temporary implantable nitinol device for minimally invasive treatment of benign prostatic hyperplasia. Therapeutic Advances in Urology 12: 1–5 | Review | While at present, only limited evidence exists to support its use, early results of this modified version are very promising. Key advantages include a strong safety profile and preservation of existing sexual function. Future studies are awaited to help delineate its formal role in current treatment algorithms. | No meta-analysis. Relevant studies have been included in the key evidence summary or appendix. |
Bertolo R, Fiori C, Amparore D et al. (2018) Follow-up of temporary implantable nitinol device (TIND) implantation for the treatment of BPH: a systematic review. Current Urology Reports 19: 44. doi: 10.1007/s11934-018-0793-0 | Systematic review | Current available evidence is limited. Sample size of patients available for analysis is small. Moreover, the duration of follow-up period is intermediate and longer follow-up is required. At the available 3 years follow-up, the TIND implantation is safe, effective, and well tolerated. | No meta-analysis. More recent studies have been included. |
Chung ASJ, Woo HH (2018) Update on minimally invasive surgery and benign prostatic hyperplasia. Asian Journal of Urology 5: 22–27 | Review | The results of the first-in-man prospective trial of the temporary implantable nitinol device procedure for treatment of LUTS caused by BPH have been promising. Phase 1, 2 and 4 studies are in progress and further validation of results awaited. | Only includes 1 relevant published study. |
Elterman DS, Zorn KC, Chughtai B et al. (2021) Is it time to offer true minimally invasive treatments (TMIST) for BPH? - A review of office-based therapies and introduction of a new technology category. The Canadian Journal of Urology 28: 10580–83 | Review | The iTind procedure appears to improve subjective and objective outcomes, but long-term data is lacking. | Relevant cited studies have been included in the key evidence summary or appendix. |
Elterman D, Gao B, Zorn KC et al. (2021) How I do it: temporarily implanted nitinol device (iTind). The Canadian Journal of Urology 28: 10788–93 | Review | The technology promises to bridge the gap between conservative medical therapy and more invasive surgical therapy. Prospective, randomised data indicate that iTind has favourable functional and sexual patient outcomes. | The main focus of the paper is to describe a standardised technique for doing the procedure. |
Franco JVA, Jung JH, Imamura M et al. Minimally invasive treatments for lower urinary tract symptoms in men with benign prostatic hyperplasia: a network meta-analysis. Cochrane Database of Systematic Reviews 2021, Issue 7. Art. No.: CD013656. DOI: 10.1002/ 14651858.CD013656.pub2. | Network meta-analysis (Cochrane review) n=3,017 (27 trials) | Minimally invasive treatments may result in similar or worse effects concerning urinary symptoms and quality of life compared to TURP at short-term follow up. They may result in fewer major adverse events. The effects of these interventions on erectile function is very uncertain. There was limited long-term data. | Review only includes 1 study (2 reports) on prostatic urethral temporary implant insertion (Chughtai et al., 2021). |
Guelce D, Kini M, Thomas D et al. (2019) BPH-related voiding dysfunction-i-Tind. Current Bladder Dysfunction Reports 14: 9–12 | Review 7 studies | There is promising evidence for the use of i-Tind as an office-based treatment for BPH. An important consideration, however, will centre on patient selection. There will be a cohort of men who elect to have this minimally invasive procedure over the gold standard TURP. However, this will not be a viable treatment option for men with particularly large prostate volumes. | The cited studies have been included in the key evidence summary or appendix. |
Kadner G, Valerio M, Giannakis I et al. (2020) Second generation of temporary implantable nitinol device (iTind) in men with LUTS: 2 year results of the MT-02-study. World Journal of Urology 38: 3235– 44 | Single-arm trial n=81 Follow up=2 years | iTind treatment for benign prostatic obstruction-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. | A longer term follow up of the same study has been included (Amparore et al., 2020). |
Madersbacher S, Roehrborn CG, Oelke M (2020) The role of novel minimally invasive treatments for lower urinary tract symptoms associated with benign prostatic hyperplasia. BJU International 126: 317–26 | Review | Procedures that can be performed on an outpatient basis are not an alternative for the standard patient needing BPH surgery. Their effect on urinary flow, PVR urine volume or bladder outlet obstruction is less pronounced than that of TURP. These options appear to be valuable for patients for whom surgery is inappropriate, men who want to avoid medical therapy in general, or those who want to avoid sexual side-effects associated with medical therapy or standard BPH surgery. | Both relevant studies have been included in the appendix. |
Marcon J, Magistro G, Stief CG et al. (2018) What's New in TIND? European Urology Focus 4: 40–42 | Review 2 articles | Preliminary data suggest that TIND is a safe and effective minimally invasive technique for patients with male LUTS. Symptom relief and increase in urinary flow after 36 months are promising. However, long-term results are needed. | More recent studies are included. |
Ng BHS, Chung E (2021) A state-of-art review on the preservation of sexual function among various minimally invasive surgical treatments for benign prostatic hyperplasia: Impact on erectile and ejaculatory domains. Investigative and Clinical Urology 62: 148–58 | Review | To date, there are very little direct comparative clinical trials among minimally invasive BPH technologies, and further studies are needed to ensure optimal patient selection, analyse cost-effectiveness and counsel patients on longer-term clinical outcomes and safety profile. | No meta-analysis. Relevant studies are included in the key evidence summary or appendix. |
Porpiglia F, Fiori C, Amparore D et al. (2019) 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. BJU International 123: 1061–69 | Single-arm trial n=81 Follow up: 12 months | 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. | A more recent publication from the same study with longer follow up is included (Amparore et al., 2020). |
Porpiglia F, Fiori C, Bertolo R et al. (2015) Temporary implantable nitinol device (TIND): a novel, minimally invasive treatment for relief of lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH): feasibility, safety and functional results at 1 year of follow-up. BJU international 116: 278–87 | Single-arm trial n=32 Follow up: 1 year | TIND implantation is a feasible and safe minimally invasive option for the treatment of BPH-related LUTS. The functional results are encouraging and the treatment significantly improved patient quality of life. Further studies are required to assess durability of TIND results and to optimise the indications of such a procedure. | A more recent publication from the same study with longer follow up is included (Porpiglia et al. 2018). |
Suarez-Ibarrola R, Miernik A, Gratzke C et al. (2020) Reasons for new MIS. Let's be fair: iTIND, Urolift and Rezum. World Journal of Urology 39: 2315–27 | Review 15 studies (2 on iTIND) | Although iTIND, Urolift, and Rezūm cannot be applied to all bladder outlet obstruction cases resulting from BPH, they provide a safe alternative for carefully selected patients who desire symptom relief and preservation of erectile and ejaculatory function without the potential morbidity of more invasive procedures. | No meta-analysis. Both relevant studies are included. |
Tzeng M, Basourakos SP, Lewicki PJ et al. (2021) New endoscopic in-office surgical therapies for benign prostatic hyperplasia: a systematic review. European Urology Focus https://doi.org/10.1016/ j.euf.2021.02.013 | Systematic review 18 articles | Among the emerging technologies introduced to treat BPH, the in-office prostatic urethral lift, water vapor thermal therapy, and temporary implantable nitinol device systems are promising options for men interested in minimally invasive, well-tolerated therapies that preserve sexual function. Although standard surgical approaches may be more effective, these advantages are valuable to certain patient populations. | No meta-analysis. All 3 relevant studies are included in the key evidence summary. |
Yalcin S, Tunc L (2020) Indications, techniques, and role of new minimally invasive benign prostate hyperplasia surgical options. Turkish Journal of Urology 46: S79–S91 | Review | Novel emerging techniques for the surgical treatment of BPH related to LUTS are being investigated. These methods, which are still being studied, are promising for the future. As the studies get completed, the indications will become clearer, and these techniques will find their respective places as the personalised treatment options. | No meta-analysis. All 5 relevant studies are included in the key evidence summary or appendix. |
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