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Randomized Controlled Trial
. 2023 Jan;37(1):74-79.
doi: 10.1089/end.2022.0226. Epub 2022 Oct 3.

An Evaluation of Sexual Function in the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia in Men Treated with the Temporarily Implanted Nitinol Device

Dean Elterman  1 , Mark N Alshak  2 , Susana Martinez Diaz  2 , Neal Shore  3 , Marc Gittleman  4 , Jay Motola  5 , Sheldon Pike  6 , Craig Hermann  7 , William Terens  8 , Alfred Kohan  9 , Ricardo Gonzalez  10 , Aaron Katz  11 , Jeffrey Schiff  11 , Evan Goldfischer  12 , Ivan Grunberger  13 , Le Tu  14 , Jed Kaminetsky  15 , Bilal Chughtai  2
Affiliations
Randomized Controlled Trial

An Evaluation of Sexual Function in the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia in Men Treated with the Temporarily Implanted Nitinol Device

Dean Elterman et al. J Endourol. 2023 Jan.

Abstract

Purpose: To document the effect of the temporarily implanted nitinol device (iTind; Medi-Tate Ltd, Israel) on sexual function from a multicenter, randomized, single-blinded, sham-controlled trial. Materials and Methods: 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. Results: 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 with baseline. Men in the iTind arm without erectile dysfunction at baseline 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. Conclusion: 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. Clinicaltrials.gov: NCT02506465.

Keywords: lower urinary tract symptoms; men's health; minimally invasive surgical procedures; prostatic hyperplasia.

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Conflict of interest statement

D.E. is on the medical advisory board. B.C. is a consultant for Medi-Tate Ltd., Olympus, Boston Scientific, and Medeon Bio. The other authors have no conflicts of interest.

Figures

FIG. 1.
FIG. 1.
Changes in total IIEF scores from baseline within the iTind subgroup, baseline total SHIM >21. *Statistically significant value (p < 0.05). IIEF = International Index of Erectile Function; iTIND = temporarily implanted nitinol device; SHIM = Sexual Health Inventory for Men.
FIG. 2.
FIG. 2.
Changes IIEF question 9 (ejaculation upon orgasm) scores from baseline within the iTind subgroup, baseline total SHIM >21. *Statistically significant value (p < 0.05).
See this image and copyright information in PMC

References

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