Temporarily Implanted Nitinol Device (iTIND) for Benign Prostatic Hyperplasia

Número de política: MA 1.164

Fecha de entrada en vigencia: 1/1/2026

Política

The use of a temporarily implanted nitinol device (e.g., iTIND) is considered investigational as a treatment of lower urinary tract symptoms due to benign prostatic hyperplasia. No hay pruebas suficientes que respalden una conclusión con respecto a los resultados o beneficios en la salud asociados con este procedimiento.

Referencias cruzadas

• MP 1.147 Prostatic Urethral Lift
• MP 4.043 Treatments of the Prostate (Focal, Water Vapor, Aquablation, and Hydrogel Spacer)
• MP 5.035 Magnetic Resonance–Guided Focused Ultrasound

Variaciones del producto

Esta política solo se aplica a ciertos programas y productos administrados por Capital Blue Cross y está sujeta a variaciones en los beneficios. Consulte la información adicional a continuación.

FEP PPO - Consulte el Manual de Políticas Médicas de FEP.

Descripción/Antecedentes

Hiperplasia prostática benigna

La hiperplasia prostática benigna (BPH) es un trastorno común entre las personas mayores que es provocado por nódulos hiperplásicos en la zona periuretral o transicional de la próstata. The clinical manifestations of BPH include increased urinary frequency, nocturia, urgency, incontinence, straining to urinate, and a weak stream when urinating. Los síntomas del tracto urinario a menudo progresan con un empeoramiento de la hipertrofia y pueden conducir a retención urinaria aguda, incontinencia, insuficiencia renal y/o infección del tracto urinario. Benign prostatic hyperplasia prevalence increases with age and is present in more than 80% of individuals age 70 to 79 years.

Two scores are often used to evaluate BPH-related symptoms: the American Urological Association Symptom Index (AUA-SI) and the International Prostate Symptom Score (IPSS). The AUA-SI is a self-administered questionnaire that assesses urinary symptoms. Total scores range from 0 to 35, with higher scores indicating more severe symptoms. IPand one additional question on quality of life.

La hiperplasia prostática benigna no siempre requiere tratamiento. ​​​​​​​La decisión de tratar la HPB se basa en la evaluación del impacto de los síntomas en la calidad de vida del paciente, junto con los posibles efectos secundarios del tratamiento. For patients with moderate-to-severe symptoms (e.g., an AUASI score of ≥8), bothersome symptoms, or both, a discussion about medical therapy is reasonable. Por lo general, la hiperplasia prostática benigna debe abordarse primero con tratamientos médicos. Available medical therapies for BPH-related lower urinary tract dysfunction include α-adrenergic blockers (e.g., alfuzosin, doxazosin, tamsulosin, terazosin, silodosin), 5α-reductase inhibitors (e.g., finasteride, dutasteride), combination α-adrenergic blockers and 5α-reductase inhibitors, anti-muscarinic agents (e.g., darifenacin, solifenacin, oxybutynin), and phosphodiesterase-5 inhibitors (e.g., tadalafil).1, In a meta-analysis of both indirect comparisons from placebo-controlled studies (n=6333) and direct comparative studies (n=507), Djavan et al (1999) found that the IPSS improved by 30% to 40% and the Qmax score (mean peak urinary flow rate) improved by 16% to 25% in individuals assigned to α-adrenergic blockers. Se ha demostrado que la terapia combinada con un bloqueador α-adrenérgico y un inhibidor de la 5α-reductasa es más eficaz para mejorar el IPSS que cualquiera de los tratamientos solos, ya que se observó una mejora de las puntuaciones medianas de más del 40% en 1 años y de más del 45% en 4 años.

Los pacientes que no muestran suficiente respuesta a la terapia médica, o que experimentan efectos secundarios significativos con ella, pueden ser derivados para terapias quirúrgicas o ablativas. La Asociación Americana de Urología (AUA, por sus siglas en inglés) recomienda la intervención quirúrgica para los pacientes que tienen "insuficiencia renal secundaria a la BPH, retención urinaria refractaria secundaria a la BPH, infecciones recurrentes del tracto urinario (UTI), cálculos vesicales recurrentes o hematuria macroscópica debido a la BPH, y/o síntomas del tracto urinario inferior (LUTS) atribuidos a la BPH, que son refractarios a otras terapias y/o no están dispuestos a probarlas". La resección transuretral de la próstata (TURP) se considera generalmente el estándar de referencia en las comparaciones de los procedimientos para BPH. En el período perioperatorio, la TURP presenta los riesgos de cualquier procedimiento quirúrgico (p. ej., los riesgos de la anestesia, pérdida de sangre). Aunque los riesgos de mortalidad a corto plazo son generalmente bajos, un gran estudio prospectivo con 10,654 pacientes realizado por Reich et al. (2008) informó las siguientes complicaciones a corto plazo: "incapacidad para orinar (5,8%), revisión quirúrgica (5,6%), infección urinaria significativa (3,6%), sangrado que requirió transfusiones (2,9%) y síndrome de resección transuretral (1,4%)". Se diagnosticó carcinoma incidental de próstata mediante examen histológico en el 9,8% de los pacientes. A largo plazo, la TURP se asocia con un mayor riesgo de disfunción sexual e incontinencia.

The use of the iTind temporarily implanted nitinol device has been investigated as a minimally invasive treatment for lower urinary tract symptoms associated with BPH. With the use of a rigid cytoscope, the device is temporarily implanted into the obstructed prostatic urethra where 3 double intertwined nitinol struts configured in a tulip shape gradually expand. The resulting circumferential force facilitates tissue reshaping via ischemic necrosis of the mucosa, resulting in urethral expansion and prostatic incisions that function as longitudinal channels to improve urine outflow. The implant is typically removed after 5 to 7 days of treatment. A distal nylon wire facilitates device retrieval which may be approached using a snare to pull the device into either a cytoscope sheath or an open-ended silicone catheter (20-22 Fr).10, The first-generation TIND device had one extra strut and a pointed tip covered by a soft plastic material.

Situación reglamentaria

In April 2019, the iTind System (Olympus; previously, Medi-Tate Ltd., Hadera, Israel) was granted a de novo 510(k) classification by the U.S. Food and Drug Administration (FDA) (DEN190020; product code: QKA). The new classification applies to this device and substantially equivalent devices of this generic type (e.g., K210138). The iTind System is intended for the treatment of symptoms due to urinary outflow obstruction secondary to BPH in men age 50 years and older.

Fundamento

Resumen de la evidencia

For individuals who have benign prostatic hyperplasia (BPH) with lower urinary tract symptoms who receive a temporarily implanted nitinol device (e.g., iTind), the evidence includes a meta-analysis, 1 randomized controlled trial (RCT), and 2 single-arm, multicenter, international prospective studies. Los resultados relevantes son los síntomas, los resultados funcionales, las medidas del estado de salud, la calidad de vida y la morbilidad relacionada con el tratamiento. One network meta-analysis compared the safety and efficacy of various minimally-invasive treatments for lower urinary tract symptoms associated with BPH, finding that iTind may result in worse urologic symptoms scores compared to transurethral resection of the prostate (TURP) at short-term follow-up. One RCT compared the iTind device with a sham procedure and reported an improvement of at least 3 points on the International Prostate Symptom Score (IPSS) scale at 3 months in 78.6% versus 60% of participants, respectively (p=.029). However, corresponding changes in overall IPSS, IPSS quality of life, peak urinary flow rate, Sexual Health Inventory for Men (SHIM), and International Index of Erectile Function scores were not significantly different between groups. One single-arm study reported significant improvements in symptoms and functional outcomes through >4 years. A subsequent single-arm study enrolling men desiring to preserve ejaculatory function reported no significant change in the SHIM total score and a statistically significant improvement on the Male Sexual Health Questionnaire for Ejaculatory Dysfunction questionnaire at 6 months. No studies have directly compared iTind to established alternatives; however, an RCT comparing iTind with the UroLift prostatic urethral lift procedure is currently ongoing. Las pruebas son insuficientes para determinar que la tecnología da lugar a una mejora en el resultado neto para la salud.

Definiciones

NA

Exención de responsabilidad

Las políticas médicas de Capital Blue Cross se utilizan para determinar la cobertura de tecnologías, procedimientos, equipos y servicios médicos específicos. Estas políticas médicas no constituyen asesoramiento médico y están sujetas a cambios según lo exija la ley o las pruebas clínicas aplicables de las directrices de tratamiento independientes. Los proveedores que brindan tratamiento son individualmente responsables de los consejos médicos y el tratamiento de los miembros. Estas pólizas no son una garantía de cobertura o pago. El pago de las reclamaciones está sujeto a la determinación del programa de beneficios del miembro y la elegibilidad en la fecha del servicio, y a la determinación de que los servicios son médicamente necesarios y apropiados. El procesamiento final de una reclamación se basa en los términos del contrato que se aplican al programa de beneficios de los miembros, incluidas las limitaciones y exclusiones de beneficios. Si un proveedor o miembro tiene alguna pregunta sobre esta política médica, debe comunicarse con Servicios para proveedores o Servicios para miembros de Capital Blue Cross.

Información de codificación

Nota: Es posible que esta lista de códigos no sea exhaustiva y que los códigos estén sujetos a cambios en cualquier momento. La identificación de un código en esta sección no denota cobertura, ya que la cobertura está determinada por los términos de la información de beneficios del miembro. Además, no todos los servicios cubiertos son elegibles para un reembolso por separado.

Investigational for Nitinol / iTind Device; therefore, not covered:

Referencias

1. Sarma AV, Wei JT. Clinical practice. Benign prostatic hyperplasia and lower urinary tract symptoms. N Engl J Med. Jul 19 2012; 367(3): 248-57. PMID 22808960
2. Barry MJ, Fowler FJ, O'Leary MP, et al. Measuring disease-specific health status in men with benign prostatic hyperplasia. Measurement Committee of The American Urological Association. Med Care. Apr 1995; 33(4 Suppl): AS145-55. PMID 7536866
3. O'leary MP. Validity of the "bother score" in the evaluation and treatment of symptomatic benign prostatic hyperplasia. Rev Urol. 2005; 7(1): 1-10. PMID 16985801
4. Djavan B, Marberger M. A meta-analysis on the efficacy and tolerability of alpha1-adrenoceptor antagonists in patients with lower urinary tract symptoms suggestive of benign prostatic obstruction. Eur Urol. 1999; 36(1): 1-13. PMID 10364649
5. Lerner LB, McVary KT, Barry MJ, et al. Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA GUIDELINE PART II-Surgical Evaluation and Treatment. J Urol. Octubre de 2021; 206(4): 818-826. PMID 34384236
6. Foster HE, Barry MJ, Dahm P, et al. Surgical Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA Guideline. J Urol. Septiembre de 2018; 200(3): 612-619. PMID 29775639
7. Reich O, Gratzke C, Bachmann A, et al. Morbidity, mortality and early outcome of transurethral resection of the prostate: a prospective multicenter evaluation of 10,654 patients. J Urol. Jul 2008; 180(1): 246-9. PMID 18499179
8. Amparore D, De Cillis S, Volpi G, et al. First- and Second-Generation Temporary Implantable Nitinol Devices As Minimally Invasive Treatments for BPH-Related LUTS: Systematic Review of the Literature. Curr Urol Rep. Jul 05 2019; 20(8): 47. PMID 31278441
9. Fiori C, De Cillis S, Volpi G, et al. iTIND for BPH: Technique and procedural outcomes: A narrative review of current literature. Turk J Urol. Nov 2021; 47(6): 470-481. PMID 35118965
10. Balakrishnan D, Jones P, Somani BK. iTIND: the second-generation temporary implantable nitinol device for minimally invasive treatment of benign prostatic hyperplasia. Ther Adv Urol. 2020; 12: 1756287220934355. PMID 32655690
11. Rosen RC, Catania JA, Althof SE, et al. Development and validation of four-item version of Male Sexual Health Questionnaire to assess ejaculatory dysfunction. Urology. May 2007; 69(5): 805-9. PMID 17482908
12. Cappelleri JC, Rosen RC. The Sexual Health Inventory for Men (SHIM): a 5-year review of research and clinical experience. Int J Impot Res. 2005; 17(4): 307-19. PMID 15875061
13. Sønksen J, Barber NJ, Speakman MJ, et al. Prospective, randomized, multinational study of prostatic urethral lift versus transurethral resection of the prostate: 12-month results from the BPH6 study. Eur Urol. Oct 2015; 68(4): 643-52. PMID 25937539
14. Barry MJ, Williford WO, Chang Y, et al. Benign prostatic hyperplasia specific health status measures in clinical research: how much change in the American Urological Association symptom index and the benign prostatic hyperplasia impact index is perceptible to patients?. J Urol. Nov 1995; 154(5): 1770-4. PMID 7563343
15. Roehrborn CG, Wilson TH, Black LK. Quantifying the contribution of symptom improvement to satisfaction of men with moderate to severe benign prostatic hyperplasia: 4-year data from the CombAT trial. J Urol. Mayo de 2012; 187(5): 1732-8. PMID 22425127
16. Porpiglia F, Fiori C, Bertolo R, et al. 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 Int. Aug 2015; 116(2): 278-87. PMID 25382816
17. Porpiglia F, Fiori C, Bertolo R, et al. 3-Year follow-up of temporary implantable nitinol device implantation for the treatment of benign prostatic obstruction. BJU Int. Jul 2018; 122(1): 106-112. PMID 29359881
18. Franco JV, 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 Syst Rev. Jul 15 2021; 7(7): CD013656. PMID 34693990
19. Chughtai B, Elterman D, Shore N, et al. The iTind Temporarily Implanted Nitinol Device for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Multicenter, Randomized, Controlled Trial. Urology. Jul 2021; 153: 270-276. PMID 33373708
20. Amparore D, Fiori C, Valerio M, et al. 3-Year results following treatment with the second generation of the temporary implantable nitinol device in men with LUTS secondary to benign prostatic obstruction. Prostate Cancer Prostatic Dis. Jun 2021; 24(2): 349-357. PMID 33005003
21. Amparore D, De Cillis S, Schulman C, et al. Temporary implantable nitinol device for benign prostatic hyperplasia-related lower urinary tract symptoms: over 48-month results. Minerva Urol Nephrol. Dic. de 2023; 75(6): 743-751. PMID 37350585
22. De Nunzio C, Cantiello F, Fiori C, et al. 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. World J Urol. Jun 2021; 39(6): 2037-2042. PMID 32851439
23. Porpiglia F, Fiori C, Amparore D, et al. 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 Int. Junio de 2019; 123(6): 1061-1069. PMID 30382600
24. Kadner G, Valerio M, Giannakis I, et al. Second generation of temporary implantable nitinol device (iTind) in men with LUTS: 2 year results of the MT-02-study. World J Urol. Dec 2020; 38(12): 3235-3244. PMID 32124019
25. Sandhu JS, Bixler BR, Dahm P, et al. Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia (BPH): AUA Guideline Amendment 2023. J Urol. Enero de 2024; 211(1): 11-19. PMID 37706750
26. Instituto Nacional para la Salud y la Excelencia Asistencial (NICE). Interventional procedures guidance: prostatic urethral temporary implant insertion for lower urinary tract symptoms caused by benign prostatic hyperplasia [IPG737]. September 21, 2022; https://www.nice.org.uk/guidance/ipg737. Accessed October 18, 2024.

Historial de políticas

• MA 1.164
• 9/12/2025 Creation of policy.