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

Nunzio, Cosimo De; Cantiello, Francesco; Fiori, Cristian; Crocerossa, Fabio; Tognoni, P.; Baldassarri, Valeria; Elbers, Javier Reinoso; Sancha, Fernando Gómez; Porpiglia, Francesco

doi:10.1007/s00345-020-03418-2

Cited by 28 publications

(19 citation statements)

References 22 publications

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“…Eighty-one men with prostate volumes < 75 mL showed sustained improvements in IPSS (20.7 to 8.55), IPSS QoL (3.96 to 1.76), and Qmax (7.71 mL/s to 15.2 mL/s) at 3 years. Soon after, De Nunzio et al published their 6-month results which enrolled 70 men with expanded inclusion criteria (prostate volumes < 120 mL) [32]. Like the previous study, the iTIND device showed significant improvements in IPSS (21.2 to 8.3), IPSS QoL (4.1 to 2.0), and Qmax (7.3 to 12.0) at 6-month follow-up.…”

Section: True Minimally Invasive Surgical Therapiesmentioning

confidence: 82%

Office-Based Procedures for BPH

Gao

Bhojani

et al. 2021

Curr Urol Rep

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Purpose of Review Benign prostatic hyperplasia (BPH) is a common disease in men. A rapidly rising demand for safe and effective therapy for BPH has generated novel minimally invasive surgical treatments (MISTs). With multiple procedural options in the urology armamentarium for BPH therapy, we describe the current therapies and outcomes for office-based procedures for BPH including quality of life, voiding symptoms, and sexual function. Recent Findings There are three FDA-approved MISTs (Rezūm, Urolift, and iTind) and three emerging MISTs for BPH. Preliminary data suggest improvement in voiding symptoms and quality of life while minimizing unwanted sexual side effects. Long term data is required on the durability and safety of MISTs for BPH. Summary MISTs mark a paradigm shift in BPH management. Sandwiched between conservative medical management and conventional transurethral surgery, these novel technologies promise to combine efficacy approaching that of TURP while sparing the negative side effects. We envision a future where BPH can be diagnosed and treated in an office-based setting with a standard cystoscope in one procedure.

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Section: True Minimally Invasive Surgical Therapiesmentioning

confidence: 82%

Office-Based Procedures for BPH

Gao

Bhojani

et al. 2021

Curr Urol Rep

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“…That said, it has been proven that the level of pain during the implantation period gradually decreases over time, and even during the removal procedure it settles on VAS score range of 3.3-3.4 [22, 26, 27 ••]. Return to normal activity after device removal averages 4.3-5.5 days [26].…”

Section: Discussionmentioning

confidence: 99%

“…Moreover, the procedure appears to be safe at least up to 3 years Concerning functional outcomes, TIND has been shown to result in significant improvements in terms of IPSS, IPSS QoL, and Qmax. These improvements are recorded from the first month post-surgery and improved subsequently reaching a peak at 24 months [26]. At 3 years of followup, IPSS, IPSS QoL, and Qmax improved by − 58.2, − 55.6, and + 114.7 compared to baseline, respectively [25•].…”

Section: Discussionmentioning

confidence: 99%

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Functional Results after First- and Second-Generation Temporary Implantable Nitinol Device (TIND) for BPH: A Narrative Review of the Literature

Cillis

Volpi

Checcucci

et al. 2022

Curr Bladder Dysfunct Rep

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Purpose of review In the last decades, new promising technologies for the treatment of BPH-related lower urinary tract symptoms (LUTS) have been widely experienced in clinical practice, with the aim of offering fewer complications but similar functional outcomes compared with the gold standard transurethral resection of the prostate (TURP). Among these so-called minimally invasive approaches, transurethral implantation of first- and second-generation temporary implantable nitinol device (TIND and iTIND, respectively) (Medi-Tate; Medi-Tate Ltd., Or Akiva, Israel) has been included by the European Association of Urology (EAU) Guidelines as one of the available alternative treatments to TURP. In the present paper, we conducted a systematic review of the current literature on TIND and iTIND implantation focusing on functional outcomes. Medline, Embase, and Cochrane databases were queried for relevant Literature in May 2021. Recent findings Data regarding the use of temporary implantable nitinol device for BPH are still very limited, with only seven studies currently available in Literature. All the studies report that both TIND and iTIND procedures are safe, effective, and well tolerated. Moreover, such treatments seem to not affect patient’s sexual and ejaculatory functions. Summary Current clinical evidence suggests that temporary implantation of first- and second-generation temporary implantable nitinol devices are valid options for the minimally invasive surgical treatment of BPH-related LUTS. Further studies are required in order to confirm the functional results, especially over a long-term follow up.

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“…Three prospective, randomized clinical trials (n=269) have demonstrated IPSS reduction of -45% to -60%, Qmax increase in +50% to +110%, no changes in erectile or ejaculatory function and a retreatment rate of 9% at 3 years. [96][97][98] Long term durability studies are pending.…”

Section: Temporary Implantable Nitinol Device (Itind)mentioning

confidence: 99%

UPDATE – 2022 Canadian Urological Association guideline on male lower urinary tract symptoms/benign prostatic hyperplasia (MLUTS/BPH)

Aubé-Peterkin

Evans

Elmansy

et al. 2022

CUAJ

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These guidelines are directed toward the typical male patient over 50 years of age, presenting with LUTS and benign prostatic enlargement (BPE) and/or benign prostatic obstruction (BPO). It is recognized that men with LUTS associated with causes other than BPO may require more extensive diagnostic workup and different treatment considerations. We acknowledge that not all patients identify as male. These guidelines should also be applicable to non-binary people, transwomen, and any patients who may have anatomical features of a cis-male genitourinary tract such as a prostate. It is our intent to make these guidelines inclusive to all persons experiencing lower urinary tract symptoms or an enlarged prostate.In this document, we will address both diagnostic and treatment issues. Diagnostic guidelines are described in the following terms as: mandatory, recommended, optional, or not recommended. The recommendations for diagnostic guidelines and principles of treatment were developed on the basis of clinical principle (widely agreed upon by Canadian urologists) and/or expert opinion (consensus of committee and reviewers). The grade of recommendation will not be offered for diagnostic recommendations. Guidelines for treatment are described using the GRADE approach 4 for summarizing the evidence and making recommendations Diagnostic guidelinesThe committee recommended minor revisions in regard to diagnostic considerations as outlined in the 2018 CUA BPH guideline. 1 MandatoryIn the initial evaluation of a man presenting with LUTS, the evaluation of symptom severity and bother is essential. Medical history should include relevant prior and current illnesses, as well as prior surgery and trauma. Current medication, including over-the-counter drugs and phytotherapeutic agents, must be reviewed. A focused physical examination, including a digital rectal exam (DRE), is also mandatory. Urinalysis is required to rule out diagnoses other than BPH that may cause LUTS and may require additional diagnostic tests. [1][2][3]5,6,7 -History -Physical examination including DRE -Urinalysis Recommended Symptom inventory (should include bother assessment)A formal symptom inventory (e.g., International Prostate Symptom Score [IPSS] or AUA Symptom Index [AUA-SI]) is recommended for an objective assessment of symptoms at CUAJ -CUA Guideline Elterman et al CUA guideline: BPH/LUTS 3

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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

Cited by 28 publications

References 22 publications

Office-Based Procedures for BPH

Office-Based Procedures for BPH

Functional Results after First- and Second-Generation Temporary Implantable Nitinol Device (TIND) for BPH: A Narrative Review of the Literature

UPDATE – 2022 Canadian Urological Association guideline on male lower urinary tract symptoms/benign prostatic hyperplasia (MLUTS/BPH)

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