To document the effect of the temporarily implanted nitinol device (iTind, Olympus, Shinjuku City, Tokyo, Japan) on sexual function from a multicenter, randomized, single-blinded, sham-controlled trial.
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.
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 to baseline. Men in the iTind arm without erectile dysfunction (ED) at baseline also 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.
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.
Journal of endourology. 2022 Sep 07 [Epub ahead of print]
Dean Elterman, Mark Alshak, Susana Martinez Diaz, Neal Shore, Marc Gittleman, Jay Motola, Sheldon Pike, Craig Hermann, William Terens, Alfred Kohan, Ricardo Gonzalez, A E Katz, Jeffrey Schiff, Evan Goldfischer, Ivan Grunberger, Le Mai Tu, Jed Kaminetsky, Bilal Chughtai
University Health Network, Urology, Toronto, Canada; ., Weill Cornell Medical Center, Urology, new york, New York, United States; ., Weill Cornell Medical Center, Urology, new york, New York, United States; ., Carolina Urology Research Center, Myrtle Beach, South Carolina, United States; ., South Florida Medical Research, Miami, United States; ., Mt Sinai Hospital, New York, United States; ., St John's Episcopal, New York, New York, United States; ., Clinical Research Center of Florida, Miami, United States; ., Premier Urology Group, New Jersey, United States; ., Integrated Medical Professionals, Long Island, United States; ., Houston Metro Urology, Houston, United States; ., New York University, New York, United States; ., NYU Winthrop Hospital, New York, United States; ., Premier Medical Group of the Hudson Valley, Poughkeepsie, United States; ., NewYork-Presbyterian Brooklyn Methodist Hospital, Urology, Brooklyn, New York, United States; ., Sherbrooke University Hospital, Sherbrooke, Canada; ., University Urology, New York, New York, United States; ., Weill Cornell Medical Center, Urology, 425 East 61st Street, 12th Floor, new york, New York, United States, 10065; .