The iTind Temporarily Implanted Nitinol Device for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Multicenter, Randomized, Controlled Trial

Chughtai, Bilal; Shore, Neal D.; Gittleman, Marc; Motola, Jay; Pike, Sheldon; Hermann, Craig; Terrens, William; Kohan, Alfred; González, Ricardo R.; Katz, Aaron E.; Schiff, Jeffrey; Goldfischer, Evan R.; Grunberger, Ivan; Tu, Le Mai; Alshak, Mark N.; Kaminetzky, Jed

doi:10.1016/j.urology.2020.12.022

Cited by 45 publications

(50 citation statements)

References 23 publications

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“…At 12 months the iTIND group demonstrated a decrease in IPSS score of 9.25 points, 3.25 ml/s improvement in flow and 1.9 point improvement in quality of life score. 42 Across both studies adverse events remained rare and no cases of de novo ejaculatory or erectile function were reported. Neither study looked at the role of iTIND in patients with retention.…”

Section: Itindmentioning

confidence: 95%

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Modern advancements in minimally invasive surgical treatments for benign prostatic obstruction

Pascoe

Fontaine

Hashim

2021

Therapeutic Advances in Urology

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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.

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Section: Itindmentioning

confidence: 95%

“…At 12 months the iTIND group demonstrated a decrease in IPSS score of 9.25 points, 3.25 ml/s improvement in flow and 1.9 point improvement in quality of life score. 42 …”

Section: Itindmentioning

confidence: 99%

Modern advancements in minimally invasive surgical treatments for benign prostatic obstruction

Pascoe

Fontaine

Hashim

2021

Therapeutic Advances in Urology

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“…Details surrounding this study design have previously been reported. 9 Briefly, 16 centers (14 in the United States, 2 in Canada) between July 2015 and October 2018 participated in this prospective, randomized, single-blinded study of the second-generation iTind procedure in men with symptomatic BPH. The study was approved by both the FDA and Health Canada, along with Institutional Review Boards at each of the centers.…”

Section: Methodsmentioning

confidence: 99%

“…As previously described, the iTind device comprises three elongated, intertwined nitinol struts at the 12, 5, and 7 o'clock positions, an antimigration anchoring leaflet at 6 o'clock, and a polyester retrieval suture for easy device removal. 9 …”

Section: Methodsmentioning

confidence: 99%

An Evaluation of Sexual Function in the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia in Men Treated with the Temporarily Implanted Nitinol Device

Alshak

Diaz

Shore

et al. 2023

Journal of Endourology

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Purpose: To document the effect of the temporarily implanted nitinol device (iTind; Medi-Tate Ltd, Israel) on sexual function from a multicenter, randomized, single-blinded, sham-controlled trial. Materials and Methods: Men were randomized 2:1 between iTind and sham procedure arms. The iTind was placed for 5–7 days and an 18F Foley catheter was inserted and removed for the iTind and sham group, respectively. Patients were assessed at baseline, 3, and 12 months postoperatively using the Sexual Health Inventory for Men (SHIM) and International Index of Erectile Function (IIEF). Unblinding occurred at 3 months. Results: We studied 185 men with a mean age of 61.1 ± 6.5 years. There was no difference in SHIM or total IIEF between iTind and sham at 3 months or in the iTind arm at 12 months compared with baseline. Men in the iTind arm without erectile dysfunction at baseline showed an improvement in total IIEF score of +6.07 ± 21.17 points ( p = 0.034) at 12 months, in addition to an improvement in ejaculatory function. SHIM scores remained unchanged in all groups, regardless of age, prostate volume, or baseline erectile function. Conclusion: No changes were observed in sexual and ejaculatory function of patients with iTind regardless of a man's age, prostate volume, and baseline sexual function. Clinicaltrials.gov: NCT02506465

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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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The iTind Temporarily Implanted Nitinol Device for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Multicenter, Randomized, Controlled Trial

Cited by 45 publications

References 23 publications

Modern advancements in minimally invasive surgical treatments for benign prostatic obstruction

Modern advancements in minimally invasive surgical treatments for benign prostatic obstruction

An Evaluation of Sexual Function in the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia in Men Treated with the Temporarily Implanted Nitinol Device

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

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