iTind procedure included in AUA guideline amendment for BPH-related LUTS

The iTind procedure is now included in the American Urological Association (AUA) 2023 clinical practice guideline for the management of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) following an amendment to the guideline released earlier this month, announced Olympus, the developer of the device, in a news release.¹

The amendment for the management of LUTS attributed to BPH is an update to the 2021 guideline on the topic.

iTind is a temporary nitinol device intended for use in the treatment of men aged 50 or older with BPH-related LUTS.

"We are very pleased with the AUA's decision to update the clinical treatment guideline—a great close to September's National Prostate Health Month. As a result of this guidance, more physicians will be aware of the novel iTind procedure for the minimally invasive surgical treatment of LUTS secondary to BPH. This guidance reflects compelling clinical evidence and positive clinical experience with the iTind procedure,” said Harmeet Chhabra, in the news release.¹ Chhabra is the global director for health economics and market access at Olympus Corporation.

The amendment for the management of LUTS attributed to BPH² is an update to the 2021 guideline on the topic. The inclusion of iTind is reflected in a newly added statement on temporary implanted prostatic devices.

In addition to this section, the 2023 LUTS/BPH amendment also now includes:

• [A] new section on "Legacy Technologies"
• New studies added for combination therapy using tolterodine (Detrol)/doxazosin (Cardura) vs combined mirabegron (Myrbetriq)/doxazosin and silodosin (Rapaflo) vs phosphodiesterase type 5 inhibitor
• [A] new statement on combination of low-dose daily tadalafil (Cialis) 5 mg with finasteride (Proscar)
• 60-month data added for water vapor thermal therapy
• Updates to the Prostatic Artery Embolization statement and supporting text³

According to the AUA,³ the LUTS/BPH guideline was updated based on the availability of new literature, as identified through an AUA Update Literature Review process.

Data on iTind

Data from the MT02 study (NCT02145208) evaluating the long-term efficacy of the iTind device in patients with BPH-related LUTS showed a significant and durable reduction in symptoms and improved quality of life (QoL) for more than 48 months following treatment.⁴

In total, 41 patients were followed for 50 to 79 months following treatment with an average follow-up time of 60.2 months. Patients included in the long-term study spanned across 3 international sites in Italy, Switzerland, and Belgium.

Data showed a durable improvement in patient symptoms, with an International Prostate Symptom Score (IPSS) reduction of 45.2% from baseline to 79 months following treatment (P < .0001). The average IPSS score was 11.26 (standard deviation = 7.67) among all patients. Similarly, data showed an IPSS-QoL reduction of 45.1% among all patients over the same time period (P < .0001), with an average score of 2.10 among all those included in the study (standard deviation = 1.41).

Further, there were no post-operative complications reported from 36 to 79 months, and no patients required additional medication. Only 4% of patients required surgical retreatment after 36 months. In total, 11.1% of patients from the original study cohort (n = 81) required surgical retreatment from baseline to 79 months.

References

1. Novel iTind procedure now included in treatment guideline for lower urinary tract symptoms caused by enlarged prostate. News release. Olympus Corporation. Published online and accessed September 28, 2023. https://www.prnewswire.com/news-releases/novel-itind-procedure-now-included-in-treatment-guideline-for-lower-urinary-tract-symptoms-caused-by-enlarged-prostate-301941709.html

3. 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. 2023;10.1097/JU.0000000000003698. doi:10.1097/JU.0000000000003698

3. AUA releases amendment to the management of lower urinary tract symptoms attributed to benign prostatic hyperplasia guideline. News release. American Urological Association. September 14, 2023. Accessed September 28, 2023. https://www.prnewswire.com/news-releases/aua-releases-amendment-to-the-management-of-lower-urinary-tract-symptoms-attributed-to-benign-prostatic-hyperplasia-guideline-301928085.html

4. Amparore D, De Cillis S, Schulman C, Kadner G, Fiori C, Porpiglia F. Temporary implantable nitinol device for benign prostatic hyperplasia-related lower urinary tract symptoms: over 48-month results. Minerva Urol Nephrol. Published online June 23, 2023. doi:10.23736/S2724-6051.23.05322-3