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, Mark N Alshak, Susana Martinez Diaz, Neal Shore, Marc Gittleman, Jay Motola, Sheldon Pike, Craig Hermann, William Terens, Alfred Kohan, Ricardo Gonzalez, Aaron Katz, Jeffrey Schiff, Evan Goldfischer, Ivan Grunberger, Le Tu, Jed Kaminetsky, Bilal Chughtai, Dean Elterman, Mark N Alshak, Susana Martinez Diaz, Neal Shore, Marc Gittleman, Jay Motola, Sheldon Pike, Craig Hermann, William Terens, Alfred Kohan, Ricardo Gonzalez, Aaron Katz, Jeffrey Schiff, Evan Goldfischer, Ivan Grunberger, Le Tu, Jed Kaminetsky, Bilal Chughtai

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.

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
    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
    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
    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
    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
    1. Yu X, Elliott SP, Wilt TJ, et al. . Practice patterns in benign prostatic hyperplasia surgical therapy: The dramatic increase in minimally invasive technologies. J Urol 2008;180(1):241–245; discussion 245; doi: 10.1016/j.juro.2008.03.039
    1. Roehrborn CG, Barkin J, Gange SN, et al. . Five year results of the prospective randomized controlled prostatic urethral L.I.F.T. study. Can J Urol 2017;24(3):8802–8813.
    1. McVary KT, Rogers T, Roehrborn CG. Rezūm water vapor thermal therapy for lower urinary tract symptoms associated with benign prostatic hyperplasia: 4-Year results from randomized controlled study. Urology 2019;126:171–179; doi: 10.1016/j.urology.2018.12.041
    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 2021;153:270–276; doi: 10.1016/j.urology.2020.12.022
    1. Cappelleri JC, Rosen RC. The Sexual Health Inventory for Men (SHIM): A 5-year review of research and clinical experience. Int J Impot Res 2005;17(4):307–319; doi: 10.1038/sj.ijir.3901327
    1. Rosen RC, Allen KR, Ni X, et al. . Minimal clinically important differences in the erectile function domain of the International Index of Erectile Function scale. Eur Urol 2011;60(5):1010–1016; doi: 10.1016/j.eururo.2011.07.053
    1. De Nunzio C, Cantiello F, Fiori C, et al. . Urinary and sexual function after treatment with temporary implantable nitinol device (iTind) in men with LUTS: 6-month interim results of the MT-06-study. World J Urol 2021;39(6):2037–2042; doi: 10.1007/s00345-020-03418-2
    1. McVary KT, Gange SN, Gittelman MC, et al. . Minimally invasive prostate convective water vapor energy ablation: A multicenter, randomized, controlled study for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Urol 2016;195(5):1529–1538; doi: 10.1016/j.juro.2015.10.181
    1. DeLay KJ, Nutt M, McVary KT. Ejaculatory dysfunction in the treatment of lower urinary tract symptoms. Transl Androl Urol 2016;5(4):450–459; doi: 10.1007/s11910-018-0857-z
    1. Brock G, Broderick G, Roehrborn CG, et al. . Tadalafil once daily in the treatment of lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) in men without erectile dysfunction. BJU Int 2013;112(7):990–997; doi: 10.1111/bju.12251
    1. Roehrborn CG, Rukstalis DB. Prostatic urethral lift versus medical therapy: examining the impact on sexual function in men with benign prostatic hyperplasia. Eur Urol Focus 2022;8(1):217–227; doi: 10.1016/j.euf.2020.12.013
    1. McVary KT, Gange SN, Gittelman MC, et al. . Erectile and ejaculatory function preserved with convective water vapor energy treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia: Randomized controlled study. J Sex Med 2016;13(6):924–933; doi: 10.1016/j.jsxm.2016.03.372

Source: PubMed

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

3
Předplatit