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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 - PubMed

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).

References

    1. Launer BM, McVary KT, Ricke WA, et al. The rising worldwide impact of benign prostatic hyperplasia. BJU Int 2021;127(6):722–728; doi: 10.1111/bju.15286 - DOI - PMC - PubMed
    1. Cindolo L, Pirozzi L, Fanizza C, et al. Drug adherence and clinical outcomes for patients under pharmacological therapy for lower urinary tract symptoms related to benign prostatic hyperplasia: Population-based cohort study. Eur Urol 2015;68(3):418–425; doi: 10.1016/j.eururo.2014.11.006 - DOI - PubMed
    1. Leong JY, Patel AS, Ramasamy R. Minimizing sexual dysfunction in BPH surgery. Curr Sex Health Rep 2019;11(3):190–200; doi: 10.1007/s11930-019-00210-1 - DOI - PMC - PubMed
    1. Flynn KE, Lin L, Bruner DW, et al. Sexual satisfaction and the importance of sexual health to quality of life throughout the life course of U.S. adults. J Sex Med 2016;13(11):1642–1650; doi: 10.1016/j.jsxm.2016.08.011 - DOI - PMC - PubMed
    1. Chung A, Woo HH. Preservation of sexual function when relieving benign prostatic obstruction surgically: Can a trade-off be considered? Curr Opin Urol 2016;26(1):42–48; doi: 10.1097/MOU.0000000000000247 - DOI - PubMed

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