iTind device improves urinary function while preserving sexual function

Minimally-invasive treatment with the iTind device (Medi-Tate) provides rapid and sustained improvement of lower urinary tract symptoms in men with benign prostatic hyperplasia (BPH), without adversely affecting patients’ sexual function, according to a recently published 12-month study.¹

iTind is an alternative to pharmaceutical management and surgery for relieving BPH-associated lower urinary tract symptoms in men with prostate volumes of less than 75 mL, no obstructive median lobe, a high bladder neck, and good bladder function. Urologists can do the procedure in the office, placing the self-expanding temporary nitinol device in a folded configuration in the prostatic urethra. The device expands during the next 5 to 7 days before urologists completely remove it.

“Current therapies for lower urinary tract symptoms secondary to BPH involve either treating the tissue with some type of energy, whether it is vapor, electrocautery, or laser energy, or applying a permanent implant,” said study author Bilal Chughtai, MD, associate professor of urology at NewYork-Presbyterian Hospital/Weill Cornell Medical Center. “What is novel about the iTind device is it does not deploy energy into the prostate, and it is fully removed. There is nothing left behind after treatment.”

The investigators conducted a randomized controlled study of men 50 years and older, comparing 118 men who received the iTind device to 57 men in the sham control group. Researchers assessed participants at baseline, 1.5, 3, and 12 months postoperatively, using the International Prostate Symptom Score (IPSS), peak urinary flow rate, residual urine, quality of life, and the International Index of Erectile Function. Study participants were unblinded at 3 months.

The findings included the following:

• At 3 months, nearly 79% of men treated with the iTind device showed a 3 or more point reduction in the IPSS, compared with 60% of men in the sham control arm.

• At 12 months, the iTind group had a 9.25 decrease in the IPSS, a 3.52-mL/s increase in peak urinary flow rate, and a 1.9-point reduction in quality-of-life score.

• More than 38% of patients in the iTind group experienced adverse events, which were typically mild and transient, compared with the 17.5% in the sham control arm.

According to the paper, dysuria occurred in 22.9% of men and hematuria in 13.6% in the iTind arm compared with 8.8% and 0% in the sham arm within the first 30 days.

None of the men in the study experienced de novo ejaculatory or erectile dysfunction.

“This paper demonstrates the safety and efficacy of the iTind device over a 12-month period,” Chughtai said. “Ultimately, what we found was that this treatment with the iTind device did provide substantial improvement in lower urinary tract symptoms without adversely affecting sexual function. And this was done at 16 settings, so it is a therapy that has a quick learning curve and is easily deployable in the office setting, as well as in the ambulatory surgery setting.”

These results were similar to findings from 2 previous single-arm studies on the iTind device conducted in Italy.^2,3 Those study results showed the treatment provided rapid and effective relief of lower urinary tract symptoms secondary to BPH for up to 3 years.

Chughtai said the best candidates for the iTind are males who are concerned about sexual function and have a prostate volume between 25 and 75 cc, and do not have an obstructive median lobe.

More data are needed to determine if men with prostates greater than 80 grams and those with an obstructing middle lobe are candidates for the therapy.

The quality-of-life finding in this study is particularly important, according to Chughtai.

“When you talk about flow rate and residual urine in the bladder, those are objective measures that we look at to determine the success of a treatment,” he said. “But ultimately, what probably matters more for a quality-of-life condition like lower urinary tract symptoms secondary to BPH or benign prostatic obstruction is how the patients respond and how they feel. If they report a statistically significant and substantial improvement in their quality of life, that is a very important metric for providers and patients because it is saying that these patients are typically happy with the way their urinary symptoms are after treatment.”

Olympus, which holds the exclusive right to distribute the iTind device in the United States, announced the FDA’s de novo classification of the iTind device on April 6, 2020.

Disclosures: Bilal Chughtai, MD, is a consultant and investigator for Boston Scientific, Olympus Therapeutics, Medi-Tate, and Medeon Bio.

References

1. 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. Published online December 26, 2020. doi: 10.1016/j.urology.2020.12.022

2. 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. 2018;122(1):106-112. doi:10.1111/bju.14141

3. 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. 2019;123(6):1061-1069. doi:10.1111/bju.14608