madman
Super Moderator
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
Abstract
Purpose To evaluate the functional outcomes as they relate to the preservation of urinary continence and sexual function after treatment with the temporarily implanted nitinol device (iTind; Medi-Tate Ltd, Israel); a novel minimally invasive treatment for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).
Methods Men with symptomatic BPH (IPSS≥10, Qmax<12 ml/s, and prostate volume (PV)<120 ml) were invited to participate in this single-arm, prospective multicenter study (MT06). Patients were not washed out of BPH medications before the procedure. The iTind was implanted through a 22F rigid cystoscope under intravenous sedation and was removed 5–7 days later through a 22F Foley catheter under local anesthesia. Post-operative VAS and complications (Clavien DindoGrading System) were recorded. Preservation of urinary continence and erectile and ejaculatory function was assessed according to ISI, MSHQ-EjD, and SHIM questionnaires. Post-operative IPSS, QoL, Qmax, and PVR were also assessed at 1, 3, and 6 months post-operatively.
Results This interim report includes data out to 6 months on the first 70 patients enrolled in the study. The median age was 62.31 years, and the mean prostate volume was 37.68 ml (15–80 ml). Baseline and follow-up data are reported in Table 1. No intraoperative complications were observed, the average postoperative VAS score was 3.24±2.56. On average patients returned to daily life after 4.3 days following the retrieval procedure. Sexual function and urinary continence were preserved in all subjects according to the ISI, SHIM, and MSHQ-EjD questionnaires, and significant improvements (p<0.0001) from baseline levels were recorded in IPSS, QoL and peak flow.
Conclusion iTind is a well-tolerated, minimally invasive treatment for BPH-related LUTS which preserves sexual function and urinary continence, offers a rapid recovery and return to daily life, and a significant improvement of symptoms and urinary flow at 6-month follow-up.
The temporarily implanted nitinol device (iTind® Medi-Tate Ltd., Or Akiva, Israel) is a device consisting of nitinol struts which are positioned endoscopically into the prostatic urethra to remodel the bladder neck and prostatic urethra and provide relief from bothersome LUTS secondary to BPO [13, 15, 16] Although several studies have evaluated the safety and efficacy of iTind in patients with LUTS with excellent results in terms of symptoms relief and improvement in flow, no studies have been published evaluating the impact of this new device on urinary continence and sexual function using the validated tools. The aim of our study was to evaluate the preservation of urinary continence, erectile and ejaculatory function after treatment with the second generation iTind in patients with LUTS/BPH.
Ejaculation disorders still remain a major concern when dealing with BPH treatments. Recently Cacciamani et al. [25] showed in a systematic review that the new treatment modalities such as Greenlight laser vaporization, Aquablation, and prostatic artery embolization (PAE) are associated with a reduced, but still present, risk of ejaculatory function when compared to TURP. Their study also confirmed the lack of well-designed studies evaluating ejaculatory dysfunction using dedicated questionnaires as the MSHQ in LUTS/BPH patients, especially considering that ejaculation disorders are known to affect patients’ quality of life and that this remains a major outcome measure when dealing with LUTS/BPH surgery. Furthermore, reduced quality of life is the primary factor that motivates patients to seek medical advice. Recently, it has been highlighted that when considering treatments for LUTS/BPH patients are willing to trade a degree of efficacy for a lower risk of ejaculation disorders [17]. For this reason, when discussing surgical options with patients, postoperative ejaculatory disorders should always be considered. According to the current EAU guidelines, the only approved ejaculatory sparing technique is the prostatic urethral lift, while prostatic embolization, convective water vapor energy ablation (Rezum), image-guided robotic waterjet ablation (Aquabeam) and the iTind is still considered investigational. In the near future, RCTs comparing these different minimally invasive techniques will better clarify their role in patients looking to spare ejaculatory function.
Conclusions
The iTind is a well-tolerated, minimally invasive treatment for LUTS/BPH, offering a rapid recovery and return to daily life, preservation of erectile and ejaculatory function, and urinary continence as well as a significant improvement of symptoms, quality of life and urinary flow at 6-month follow-up. Further studies are necessary to assess the durability of these results and to compare the iTind with other minimally invasive treatments with a proven minimal impact on ejaculatory function.
Abstract
Purpose To evaluate the functional outcomes as they relate to the preservation of urinary continence and sexual function after treatment with the temporarily implanted nitinol device (iTind; Medi-Tate Ltd, Israel); a novel minimally invasive treatment for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).
Methods Men with symptomatic BPH (IPSS≥10, Qmax<12 ml/s, and prostate volume (PV)<120 ml) were invited to participate in this single-arm, prospective multicenter study (MT06). Patients were not washed out of BPH medications before the procedure. The iTind was implanted through a 22F rigid cystoscope under intravenous sedation and was removed 5–7 days later through a 22F Foley catheter under local anesthesia. Post-operative VAS and complications (Clavien DindoGrading System) were recorded. Preservation of urinary continence and erectile and ejaculatory function was assessed according to ISI, MSHQ-EjD, and SHIM questionnaires. Post-operative IPSS, QoL, Qmax, and PVR were also assessed at 1, 3, and 6 months post-operatively.
Results This interim report includes data out to 6 months on the first 70 patients enrolled in the study. The median age was 62.31 years, and the mean prostate volume was 37.68 ml (15–80 ml). Baseline and follow-up data are reported in Table 1. No intraoperative complications were observed, the average postoperative VAS score was 3.24±2.56. On average patients returned to daily life after 4.3 days following the retrieval procedure. Sexual function and urinary continence were preserved in all subjects according to the ISI, SHIM, and MSHQ-EjD questionnaires, and significant improvements (p<0.0001) from baseline levels were recorded in IPSS, QoL and peak flow.
Conclusion iTind is a well-tolerated, minimally invasive treatment for BPH-related LUTS which preserves sexual function and urinary continence, offers a rapid recovery and return to daily life, and a significant improvement of symptoms and urinary flow at 6-month follow-up.
The temporarily implanted nitinol device (iTind® Medi-Tate Ltd., Or Akiva, Israel) is a device consisting of nitinol struts which are positioned endoscopically into the prostatic urethra to remodel the bladder neck and prostatic urethra and provide relief from bothersome LUTS secondary to BPO [13, 15, 16] Although several studies have evaluated the safety and efficacy of iTind in patients with LUTS with excellent results in terms of symptoms relief and improvement in flow, no studies have been published evaluating the impact of this new device on urinary continence and sexual function using the validated tools. The aim of our study was to evaluate the preservation of urinary continence, erectile and ejaculatory function after treatment with the second generation iTind in patients with LUTS/BPH.
Ejaculation disorders still remain a major concern when dealing with BPH treatments. Recently Cacciamani et al. [25] showed in a systematic review that the new treatment modalities such as Greenlight laser vaporization, Aquablation, and prostatic artery embolization (PAE) are associated with a reduced, but still present, risk of ejaculatory function when compared to TURP. Their study also confirmed the lack of well-designed studies evaluating ejaculatory dysfunction using dedicated questionnaires as the MSHQ in LUTS/BPH patients, especially considering that ejaculation disorders are known to affect patients’ quality of life and that this remains a major outcome measure when dealing with LUTS/BPH surgery. Furthermore, reduced quality of life is the primary factor that motivates patients to seek medical advice. Recently, it has been highlighted that when considering treatments for LUTS/BPH patients are willing to trade a degree of efficacy for a lower risk of ejaculation disorders [17]. For this reason, when discussing surgical options with patients, postoperative ejaculatory disorders should always be considered. According to the current EAU guidelines, the only approved ejaculatory sparing technique is the prostatic urethral lift, while prostatic embolization, convective water vapor energy ablation (Rezum), image-guided robotic waterjet ablation (Aquabeam) and the iTind is still considered investigational. In the near future, RCTs comparing these different minimally invasive techniques will better clarify their role in patients looking to spare ejaculatory function.
Conclusions
The iTind is a well-tolerated, minimally invasive treatment for LUTS/BPH, offering a rapid recovery and return to daily life, preservation of erectile and ejaculatory function, and urinary continence as well as a significant improvement of symptoms, quality of life and urinary flow at 6-month follow-up. Further studies are necessary to assess the durability of these results and to compare the iTind with other minimally invasive treatments with a proven minimal impact on ejaculatory function.
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