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

ABSTRACT: 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.

SUBMITTER: Balakrishnan D

PROVIDER: S-EPMC7328474 | biostudies-literature | 2020 Jan-Dec

REPOSITORIES: biostudies-literature

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

Balakrishnan Dhivya D Jones Patrick P Somani Bhaskar K BK

Therapeutic advances in urology 20200101

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 implantat ...[more]

PMID: 32655690

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Project description:ContextSeveral newer device-based procedures have recently become available for treating men with lower urinary tract symptoms attributed to benign prostatic hyperplasia, but their effectiveness remains uncertain.ObjectiveTo assess the longer-term comparative effectiveness (defined as >12 mo of follow-up) of the newer treatment modalities prostatic urethral lift (PUL), transurethral prostate convective radiofrequency water vapor (Rezūm), Aquablation, and prostatic arterial embolization (PAE).Evidence acquisitionOvid Medline, the Cochrane Central Register of Controlled Trials (CENTRAL), and the Agency for Healthcare Research and Quality databases were searched through September 30, 2019; hand searches of references of relevant studies were also performed. Eligible studies were randomized controlled trials (RCTs) published in English language. We excluded observational studies.Evidence synthesisOne RCT (n = 91) found that patients undergoing PUL may be less likely to respond (risk ratio [RR] 0.8; 95% confidence interval [CI] 0.7-1.0; low certainty of evidence [CoE]) and have a higher mean International Prostate Symptom Score (IPSS; mean difference 6.1; 95% CI 2.2-10.0; low CoE) than those undergoing transurethral resection of the prostate (TURP). Among patients undergoing PAE, one small RCT (n = 30) reported similar IPSS response rates (RR 0.9; 95% CI 0.7-1.1; low CoE) and one trial (n = 107) found similar mean IPSS (-0.7; 95% CI -1.3 to 2.7; moderate CoE) scores to those among patients undergoing TURP. A single study on Aquablation reported 12 mo of follow-up only, and a single 3-mo trial compared Rezūm with sham treatment.ConclusionsThe current best evidence underlying these newer therapies is limited to few trials (PUL and PAE), short-term follow-up of 12 mo (Aquablation and Rezūm), or sham comparison only (Rezūm).Patient summaryEvidence for four of the newer surgical treatments for men with an enlarged prostate is limited to few small trials with short-term follow-up; only one trial compared a new treatment modality with sham surgery.

Project description:ContextBenign prostatic hyperplasia (BPH) associated with lower urinary tract symptoms (LUTS) is diagnosed in up to 80% of men during their lifetime. Several novel ultra-minimally invasive surgical treatments (uMISTs) for BPH/benign prostatic obstruction (BPO) have become available over the past 5 yr.ObjectiveTo evaluate the perioperative and functional outcomes of recently introduced uMISTs for BPH/BPO, including Urolift, Rezūm, temporary implantable nitinol device, prostatic artery embolization (PAE), and intraprostatic injection.Evidence acquisitionA systematic literature search was conducted in December 2020 using Medline (via PubMed), Embase (via Ovid), Scopus, and Web of Science (registered on PROSPERO as CRD42021225014). The search strategy used PICO criteria and article selection was conducted in accordance with the PRISMA guidelines. The risk of bias and the quality of the articles included were assessed. A dedicated data extraction form was used to collect the data of interest. Pooled and cumulative analyses were performed to compare perioperative and functional outcomes between study groups. A random-effects model using the DerSimonian and Laird method was used to evaluate heterogeneity. Stata version 15.0 software was used for all statistical analyses.Evidence synthesisThe initial electronic search identified 3978 papers, of which 48 ultimately met the inclusion criteria and were included in the analysis. Pooled analysis revealed a uMIST benefit in terms of International Prostate Symptom Score (IPSS; -9.81 points, 95% confidence interval [CI] -11.37 to -8.25 at 1 mo; -13.13 points, 95% CI -14.98 to -11.64 at 12 mo), maximum flow rate (from +3.66 ml/s, 95% CI 2.8-4.5 to +4.14 ml/s, 95% CI 0.72-7.56 at 12 mo), and postvoid residual volume (-10.10 ml, 95% CI -27.90 to 7.71 at 12 mo). No negative impact was observed on scores for the International Index of Erectile Function-5, Male Sexual Health Questionnaire-Ejaculatory Dysfunction bother and function scales (overall postintervention change in pooled median score of 1.88, 95% CI 1.34-2.42 at the start of follow-up; and 1.04, 95% CI 0.28-1.8 after 1 yr), or the IPSS-Quality of Life questionnaire.ConclusionsNovel uMISTs can yield fast and effective relief of LUTS without affecting patient quality of life. Only Rezūm, UroLift, and PAE had a minimal impact on patients' sexual function with respect to baseline, especially regarding preservation of ejaculation.Patient summaryWe reviewed outcomes for recently introduced ultra-minimally invasive surgical treatments for patients with lower urinary tract symptoms caused by benign prostate enlargement or obstruction. The evidence suggests that these novel techniques are beneficial in terms of controlling symptoms while preserving sexual function.Take home messageNovel ultra-minimally invasive treatments can yield fast and effective relief of lower urinary tract symptoms without affecting a patient's quality of life.

Dataset Information

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

Publications

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

Similar Datasets

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