Description
Benign prostatic hyperplasia (BPH) is a common condition in older individuals that can lead to increased urinary frequency, an urgency to urinate, a hesitancy to urinate, nocturia, and a weak stream when urinating. Temporarily implanted nitinol devices have been proposed as a minimally invasive alternative to transurethral resection of the prostate (TURP), considered the traditional standard treatment for symptomatic benign prostatic hyperplasia. The device is temporarily implanted into the obstructed prostatic urethra to facilitate tissue reshaping and improve urine outflow. The implant is typically removed after five to seven days of treatment.

Backgound
Benign Prostatic Hyperplasia
Benign prostatic hyperplasia (BPH) is a common disorder among older individuals that results from hyperplastic nodules in the periurethral or transitional zone of the prostate. The clinical manifestations of BPH include increased urinary frequency, nocturia, urgency or hesitancy to urinate, and a weak stream when urinating. The urinary tract symptoms often progress with worsening hypertrophy and may lead to acute urinary retention, incontinence, renal insufficiency, and/or urinary tract infection. Benign prostatic hyperplasia prevalence increases with age and is present in more than 80% of individuals age 70 to 79 years.¹

Two scores are widely used to evaluate BPH-related symptoms: the American Urological Association Symptom Index (AUASI) and the International Prostate Symptom Score (IPSS). The AUASI is a self-administered seven-item questionnaire assessing the severity of various urinary symptoms.² Total AUASI scores range from 0 to 35, with overall severity categorized as mild ( ≤ 7), moderate (8 – 19), or severe (20 – 35).¹ The IPSS incorporates questions from the AUASI and a quality of life question or a "Bother score."³

Benign prostatic hyperplasia does not necessarily require treatment. The decision on whether to treat BPH is based on an assessment of the impact of symptoms on quality of life along with the potential side effects of treatment. 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. Benign prostatic hyperplasia should generally be treated medically first. 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 = 6,333) 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.⁴ Combination therapy using an α-adrenergic blocker and 5α-reductase inhibitor has been shown to be more effective for improving IPSS than either treatment alone, with median scores improving by more than 40% over 1 year and by more than 45% over 4 years.

Patients who do not have sufficient response to medical therapy, or who are experiencing significant side effects with medical therapy, may be referred for surgical or ablative therapies. The American Urological Association (AUA) recommends surgical intervention for patients who have "renal insufficiency secondary to BPH, refractory urinary retention secondary to BPH, recurrent urinary tract infections (UTIs), recurrent bladder stones or gross hematuria due to BPH, and/or with lower urinary tract symptoms (LUTS) attributed to BPH refractory to and/or unwilling to use other therapies."⁵ Transurethral resection of the prostate (TURP) is generally considered the reference standard for comparisons of BPH procedures.⁶ In the perioperative period, TURP is associated with risks of any operative procedure (e.g., anesthesia risks, blood loss). Although short-term mortality risks are generally low, a large prospective study with 10,654 patients by Reich et al. (2008) reported the following short-term complications: "failure to void (5.8%), surgical revision (5.6%), significant urinary tract infection (3.6%), bleeding requiring transfusions (2.9%), and transurethral resection syndrome (1.4%)."⁷ Incidental carcinoma of the prostate was diagnosed by histologic examination in 9.8% of patients. In the longer term, TURP is associated with an increased risk of sexual dysfunction and incontinence.

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 three double intertwined nitinol struts configured in a tulip shape gradually expand.⁸ 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.⁹ 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.

Regulatory Status
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 benign prostatic hyperplasia (BPH) in men age 50 and older.

Policy
The use of a temporarily implanted nitinol device (e.g., iTind) is investigational/unproven there is considered NOT MEDICALLY NECESSARY as a treatment of lower urinary tract symptoms due to benign prostatic hyperplasia.

Policy Guidelines
Coding
See the Codes table for details.

Benefit Application
BlueCard^®/National Account Issues
State or federal mandates (e.g., Federal Employee Program) may dictate that certain U.S. Food and Drug Administration-approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only by their medical necessity.

Rationale
Evidence reviews assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. Randomized controlled trials are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Promotion of greater diversity and inclusion in clinical research of historically marginalized groups (e.g., people of color [African American, Asian, Black, Latino and Native American]; LGBTQIA [lesbian, gay, bisexual, transgender, queer, intersex, asexual]; women; and people with disabilities [physical and invisible]) allows policy populations to be more reflective of and findings more applicable to our diverse members. While we also strive to use inclusive language related to these groups in our policies, use of gender-specific nouns (e.g., women, men, sisters, etc.) will continue when reflective of language used in publications describing study populations.

Temporarily Implanted Nitinol Device
Clinical Context and Therapy Purpose
The purpose of temporarily implanted nitinol devices in individuals who have lower urinary tract symptoms due to benign prostatic hyperplasia (BPH) is to provide a treatment option that is an alternative to or an improvement on existing therapies such as medical management, transurethral resection of the prostate (TURP), or prostatic urethral lift (PUL).

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals who are experiencing lower urinary tract symptoms without a history suggesting non-BPH causes of the symptoms and who do not have a sufficient response to medical therapy or are experiencing significant side effects with medical therapy.

Interventions
The therapy being considered is temporary implantation of a nitinol device (e.g., iTind system). The iTind system consists of a nitinol-based implant, delivery system, and retrieval kit. The device is temporarily implanted into the obstructed prostatic urethra where it assumes its expanded configuration to facilitate tissue reshaping and improve urine outflow. The implant is typically removed after 5 to 7 days of implantation.

Comparators
The following practices are currently being used to treat BPH in this setting:

• Conservative treatment, including watchful waiting and lifestyle modifications;
• Pharmacotherapy;
• Transurethral resection of the prostate , which is generally considered the reference standard for comparisons of BPH procedures; and
• Prostatic urethral lift.

Outcomes
The general outcomes of interest are symptoms, functional outcomes, health status measures, quality of life, and treatment-related morbidity.

The International Prostate Symptom Score (IPSS) is used to assess the severity of BPH symptoms. The first 7 questions address urinary frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying, and urgency each on a scale of 0 to 5. The total score, summed across the 7 items measured, ranges from 0 (no symptoms) to 35 (most severe symptoms). A decrease in score indicates improvement.

A number of health status measures are used to evaluate symptoms relevant to BPH and adverse events of treatment for BPH, including urinary symptoms, urinary dysfunction measured by peak urinary flow rate (Qmax), ejaculatory dysfunction, overall sexual health, and overall quality of life. Qmax is measured by uroflowmetry; low rates are associated with more voiding dysfunction and rates <10 mL/sec are considered obstructed. Urinary continence may be assessed via the Incontinence Symptom Index (ISI) questionnaire. Erectile and ejaculatory function is assessed in sexually active men only. Scales include the International Index of Erectile Function (IIEF) and the Male Sexual Health Questionnaire for Ejaculatory Dysfunction(MSHQ-EjD).

Quality of life is assessed with various scales including the IPSS-QoL.

Both short-term (up to 12 months) and long-term (12 months and longer) outcomes should be assessed. Treatment-related morbidity can also be assessed in the immediate post-procedure period.

Some validated patient-reported scales are summarized in Table 1.

Table 1. Patient-Reported Health Outcome Measures Relevant to Benign Prostatic Hyperplasia

QOL: quality of life; NR: not reported.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Consistent with a 'best available evidence approach,' within each category of study design, studies with larger sample sizes and longer durations were sought.
• Studies with duplicative or overlapping populations were excluded.
• Studies concerning older versions of the technology that are no longer commercially marketed were excluded, including Porpiglia et al. (2015)¹⁶ and Porpiglia et al. (2018).¹⁷

Review of Evidence
Systematic Reviews
In 2021, Franco et al published a Cochrane network meta-analysis assessing the comparative effectiveness of minimally invasive treatments for lower urinary tract symptoms in men with BPH.¹⁸ Twenty-seven trials representing 3017 men were included through February 2021. Compared to TURP at short-term follow-up, temporary implantable nitinol devices (TIND) may result in worse urologic symptoms scores (mean difference [MD] of IPSS score, 7.5; 95% confidence interval [CI], 0.68 to 15.69; low-certainty evidence) and little to no difference in quality of life scores (MD, 0.87; 95% CI, -1.04 to 2.79; low-certainty evidence).

Randomized Controlled Trials
Chughtai et al. (2021) published the results of a multicenter, single-blinded RCT of the iTind implant compared to sham for the treatment of lower urinary tract symptoms secondary to BPH.¹⁹ Study characteristics and results are summarized in Tables 2 and 3. Fifty-seven participants received sham treatment, and out of 128 participants randomized to receive iTind, 10 did not undergo the procedure. The primary endpoint was the response rate, defined as the percentage of patients achieving a reduction of at least 3 points on the IPSS scale at 3 months. Patients were unblinded to their treatment after the 3 month follow-up visit. Mean patient age was 61.1 years and baseline characteristics were similar between groups, except for a higher Charlson Comorbidity Index score among iTind recipients (2.52 vs. 1.26; p < .001). While a significantly higher proportion of patients treated with iTind achieved the primary endpoint compared to sham at 3 months (78.6% vs. 60%; p = .029), changes in overall IPSS, IPSS-QoL, Qmax, Sexual Health Inventory for Men (SHIM), and IIEF scores were not statistically different between groups. Patients treated with iTind were followed through 12 months. Of 78 iTind subjects in the per-protocol population, a mean reduction of 9.25 points on the IPSS was found at 12 months, suggesting durability of treatment. A total of 16 serious adverse events among 10 subjects was reported within 30 days in the iTind group compared to 2 events in 2 subjects in the sham group. In the iTind group, a total of 5 serious adverse events were classified as device- or procedure-related, including urinary retention (n = 2), urinary tract infection (n = 2), and sepsis (n = 1). Six individuals (4.7%) had an alternative BPH surgery during 12-month follow-up due to deterioration of symptoms. An additional 6 participants (4.7%) resumed medication for symptomatic BPH. Study relevance, design, and conduct limitations are summarized in Tables 4 and 5. An RCT comparing the iTind device to the UroLift PUL procedure is ongoing (NCT04757116).

Table 2. Summary of Key RCT Characteristics

CBC: complete blood count; IPSS: International Prostate Symptom Score; PFR: peak urinary flow rate; PSA: prostate specific antigen; PVR: post-void residual; RCT: randomized controlled trial; UTI: urinary tract infection.
¹ Number randomized; intervention; mode of delivery; dose (frequency/duration).
² Key eligibility criteria.

Table 3. Summary of Key RCT Results

CI: confidence interval; IIEF: International Index of Erectile Function; IPSS: International Prostate Symptom Score; ITT: intention-to-treat; MD: mean difference; NA: not applicable; NR: not reported; PP: per-protocol; Qmax: peak flow rate; QoL: quality of life; RCT: randomized controlled trial; SHIM: Sexual Health Inventory for Men.

Table 4. Study Relevance Limitations

The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
^a Population key: 1. Intended use population unclear; 2. Study population is unclear; 3. Study population not representative of intended use; 4. Enrolled populations do not reflect relevant diversity; 5. Other.
^b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest (e.g., proposed as an adjunct but not tested as such); 5. Other.
^c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively; 5. Other.
^d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. Incomplete reporting of harms; 4. Not establish and validated measurements; 5. Clinically significant difference not prespecified; 6. Clinically significant difference not supported; 7. Other.
^e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms; 3. Other.

Table 5. Study Design and Conduct Limitations

The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
^a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias; 5. Other.
^b Blinding key: 1. Participants or study staff not blinded; 2. Outcome assessors not blinded; 3. Outcome assessed by treating physician; 4. Other.
^c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication; 4. Other.
^d Data Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials); 7. Other.
^e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference; 4. Other.
^f Statistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated; 5. Other.

Single-Arm Studies
MT-02 Cohort
Eighty-one subjects with lower urinary tract symptoms due to BPH were implanted with the second-generation iTind device and followed for up to > 4 years.^20,21 Study characteristics and results are summarized in Tables 6 and 7. Mean (SD) patient age was 65 (8.9) years with mean (SD) prostate volume 40.5 (12.25) mL, Qmax 7.3 (2.6) mL/s, and IPSS score 22.5 (5.6). Devices were retrieved at a mean (SD) of 5.9 (1.1) days after implantation and no intraoperative complications were reported. At the 6-month and 12-month visits, 85.2% and 88.9% of treated patients reported a 3-point or greater improvement in IPSS, respectively. Compared to baseline, none of the 61 sexually active participants who completed a 12-month, 2-item questionnaire reported sexual or ejaculatory dysfunction. Statistically significant improvements in total IPSS, Qmax, IPSS-QoL, and post-void residual (PVR) volume were observed through 36 months, and in IPSS and IPSS-QoL through > 48 months (mean, 60.2 months). Clavien-Dindo grade I, II, and IIIa treatment-related adverse events were reported in 33 (41%), 5 (6.2%), and 8 (9.9%) patients within the first month post-treatment, respectively. The most common adverse events were hematuria (12.3%), urinary urgency (11.1%), acute urinary retention (9.9%), and pain (9.9%). No further adverse events were reported during long-term follow-up. From baseline through 36 months, 12 (14.8%) patients were considered treatment failures, of which 7 were later found to have obstructive median lobes (p < .0001). Subsequent drug therapy was required in 5 (6.2%) patients and 8 (8.6%) underwent surgical retreatment via TURP or laser. Sexually active patients who completed a 2-item questionnaire reported no sexual or ejaculatory dysfunction through 3 years. Between 36 and > 48 months, 2 additional patients underwent surgical retreatment; therefore, the total retreatment rate from baseline to > 48 months was 11.1%.

MT-06 Cohort
De Nunzio et al. (2021) reported 6-month interim outcomes for 70 subjects with lower urinary tract symptoms due to BPH seeking to preserve ejaculatory function who were implanted with the second-generation iTind device.²² Study characteristics and results are summarized in Tables 6 and 7. Mean patient age was 62.3 years with mean prostate volume 37.68 mL, Qmax 7.3, and IPSS urinary symptoms score 21.2. At 6 months, statistically significant improvements were seen in IPSS urinary symptoms, IPSS-QoL, Qmax, and MSHQ-EjD. No significant changes in PVR volume, SHIM total score, or ISI total score were reported. Clavien-Dindo grade I, IIIa, and IIIb treatment-related adverse events were reported in 53 (75.7%), 3 (4.3%), and 1 (1.4%) patient(s), respectively. The most common adverse events were transient hematuria (18.6%), dysuria (17%), urinary urgency (12.8%), and pain (11.4%). Follow-up is planned for 3 years.

Table 6. Summary of Key Single-Arm Study Characteristics

BPH: benign prostatic hyperplasia; IPSS: International Prostate Symptom Score; PVR: post-void residual; Qmax: peak flow rate; UTI: urinary tract infection.

Table 7. Summary of Key Single-Arm Study Results

CI: confidence interval; IPSS: International Prostate Symptom Score; IQR: interquartile range; NR; not reported; PVR: post-void residual; Qmax: peak urinary flow rate; QoL: quality of life; SD: standard deviation.

Section Summary: Temporarily Implanted Nitinol Device
The prospective, international, multicenter, single-arm MT-02 prospective study of the iTind device has reported statistically significant improvements in total IPSS score and IPSS-QoL score through > 4 years, and Qmax and PVR volume through 3 years. The subsequent single-arm MT-06 study enrolling men desiring to preserve ejaculatory function reported no significant change in the SHIM total score and a statistically significant improvement on the MSHQ-EjD questionnaire at 6 months. One RCT comparing the iTind device to sham treatment reported an improvement of at least 3 points on the IPSS scale at 3 months in 78.6% versus 60% of participants, respectively (p = .029). However, changes in overall IPSS, IPSS-QoL, Qmax, SHIM, and IIEF scores were not significantly different between groups. Major limitations of the RCT include high loss to follow-up (~30% in each treatment arm) and short duration of follow-up. An RCT comparing the iTind device to the UroLift PUL procedure is ongoing (NCT04757116).

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Practice Guidelines and Position Statements
Guidelines or position statements will be considered for inclusion in Supplemental Information if they were issued by, or jointly by, a U.S. professional society, an international society with U.S. representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

American Urological Association
In 2021, the American Urological Association (AUA) published guidelines on the surgical evaluation and treatment of lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH).⁵ These guidelines do not address the use of temporarily implanted nitinol devices.

A 2023 amendment to the 2021 AUA guideline stated that temporary implanted prostatic devices are an option for individuals with BPH, LUTS, prostate volume of 25 to 75 grams, and who lack an obstructive median lobe.25, This recommendation was based on expert opinion due to an absence of sufficient evidence.

National Institute for Health and Care Excellence
In 2022, the National Institute for Health and Care Excellence (NICE) issued an interventional procedures guidance on prostatic urethral temporary implant insertion for lower urinary tract symptoms caused by BPH.26, The recommendation noted that the evidence on the use of these devices is limited in quantity and quality. Therefore, the procedure should only be used with special arrangements for clinical governance, consent, and audit or research.

U.S. Preventive Services Task Force Recommendations
Not applicable

Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this review are listed in Table 8.

Table 8. Summary of Key Trials

NCT: national clinical trial.
^a Denotes industry-sponsored or cosponsored trial.

References

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. Oct 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. Sep 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. May 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. Dec 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. Jun 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. Jan 2024; 211(1): 11-19. PMID 37706750
26. National Institute for Health and Care Excellence (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 November 22, 2023.

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

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