madman
Super Moderator
3-Year results following treatment with the second generation of the temporary implantable nitinol device in men with LUTS secondary to benign prostatic obstruction
Abstract
Background To report the 3-year results of a prospective, single-arm, multicenter, international clinical study with the second generation of the temporary implantable nitinol device (iTIND; Medi-Tate Ltd®, Israel) on men suffering lower urinary tract symptoms (LUTS) secondary to benign prostatic obstruction (BPO).
Methods Eighty-one men with symptomatic BPO (IPSS ≥ 10, peak urinary flow <12 ml/s, and prostate volume <75 ml) were enrolled in this study between December 2014 and December 2016. Subjects were washed-out 1 month for alpha-blockers and 6 months for 5-ARIs. The implantation was performed under light sedation and the removal 5–7 days later with topical anesthesia. Perioperative results including OR-time, pain (VAS) postoperative complications (Clavien–Dindo-Grading System), functional results (Qmax, IPSS, PVR), and quality of life (QoL) were assessed at 1, 3, 6 months, 1, 2, and 3 years. The sexual and ejaculatory function were evaluated using two yes/no questions.
Results Thirty-six month functional results were available for 50 patients and demonstrated that iTIND efficacy remained stable through 3 years, with averages IPSS, QOL, Qmax and PVR of 8.55 + 6.38, 1.76 + 1.32, 15.2 + 6.59 ml/s and 9.38 + 17.4 ml, improved from baseline by −58.2, −55.6, +114.7, and −85.4% (all significantly different from their corresponding baseline values, p < 0.0001). Even considering the Intention to Treat analysis (ITT), the 36-month results confirmed significant improvements in the functional outcomes if compared with baselines values (all p < 0.0001). No late postoperative complications were observed between 12 and 36 months. Sexual function was stable through 3 years, with no reports of sexual or ejaculatory dysfunctions. No patients underwent alternative treatments between 24 and 36 months.
Conclusion Treatment of BPO-related LUTS with iTIND demonstrated a significant and durable reduction in symptoms and improvement of functional parameters and quality of life at 3 years of follow-up. No late postoperative complications, ejaculatory dysfunction, or additional treatment failures were observed between 24 and 36 months.
Introduction
Lower urinary tract symptoms (LUTS) secondary to benign prostatic obstruction (BPO) is one of the most common conditions which can negatively impact the quality of life of men in their lifetime. Prevalence of benign prostatic hyperplasia (BPH) that can lead to BPO starts at age 40–45 years, reaches 60% by age 60, and can be as much as 80% by age 80 [1].
Treatment for reducing LUTS secondary to BPO often begins with watchful waiting and implementation of lifestyle changes, and then progresses to pharmaceutical therapy with the use of selective alpha-blockers, with or without 5-alpha reductase inhibitors [2, 3]. Despite pharmaceutical therapy being considered the first line of treatment, many patients are unhappy with the level of symptomatic relief it offers, or are bothered by treatment-induced side effects, such as dizziness and sexual dysfunction. For this reason, treatment compliance is low, with only ~29–30% of patients adhering to treatment during the first 12 months [3, 4].
The gold standard surgical treatment for BPH today is trans-urethral resection of the prostate (TURP), which offers a significant and durable reduction in symptoms and an increase in urinary flow. However, TURP is also associated with a 20% morbidity rate, including urinary incontinence (3%), bleeding requiring blood transfusion (2.9%), urethral stricture (7%), TUR syndrome (1.4%), erectile dysfunction (10%) and retrograde ejaculation (65%) [5–7].
New, laser-based ablative techniques, while also effective in providing relief of BPH-related symptoms, still present complications similar to those seen with TURP [7–9].
The temporary implantable nitinol device was developed to offer an effective and minimally invasive alternative for treating LUTS due to BPO through the use of a temporarily implanted device. The device, left in place for only 5–7 days, remodels the prostatic urethra and bladder neck through ischemic pressure, effectively relieving the obstruction to the bladder outlet without ablating or resecting tissue, and without leaving a permanent implant in the body.
In the first-in-man, 3-year clinical study of the first-generation device (TIND; Medi-Tate Ltd., Israel), and in the multicenter, prospective analysis of the 1 and 2 years performance of the second-generation device (iTIND), this minimally invasive approach demonstrated safety and effectiveness leading to significant and stable relief of BPO associated LUTS as measured by IPSS, QoL, and improved functional results [10–13].
The aim of the present study is to report on the outcomes of patients 3 years after treatment with iTIND.
Conclusion
Treatment of BPO-related LUTS with the second-generation temporary implantable nitinol device demonstrated a significant and durable reduction in symptoms and improvement in functional parameters and quality of life at 3 years of follow-up. As for the first-generation device, no late postoperative complications were observed between 12 and 36 months. No impact on ejaculatory function and a low, total, and cumulative (8.6%) treatment failure rate from baseline to 3 years was recorded.
Abstract
Background To report the 3-year results of a prospective, single-arm, multicenter, international clinical study with the second generation of the temporary implantable nitinol device (iTIND; Medi-Tate Ltd®, Israel) on men suffering lower urinary tract symptoms (LUTS) secondary to benign prostatic obstruction (BPO).
Methods Eighty-one men with symptomatic BPO (IPSS ≥ 10, peak urinary flow <12 ml/s, and prostate volume <75 ml) were enrolled in this study between December 2014 and December 2016. Subjects were washed-out 1 month for alpha-blockers and 6 months for 5-ARIs. The implantation was performed under light sedation and the removal 5–7 days later with topical anesthesia. Perioperative results including OR-time, pain (VAS) postoperative complications (Clavien–Dindo-Grading System), functional results (Qmax, IPSS, PVR), and quality of life (QoL) were assessed at 1, 3, 6 months, 1, 2, and 3 years. The sexual and ejaculatory function were evaluated using two yes/no questions.
Results Thirty-six month functional results were available for 50 patients and demonstrated that iTIND efficacy remained stable through 3 years, with averages IPSS, QOL, Qmax and PVR of 8.55 + 6.38, 1.76 + 1.32, 15.2 + 6.59 ml/s and 9.38 + 17.4 ml, improved from baseline by −58.2, −55.6, +114.7, and −85.4% (all significantly different from their corresponding baseline values, p < 0.0001). Even considering the Intention to Treat analysis (ITT), the 36-month results confirmed significant improvements in the functional outcomes if compared with baselines values (all p < 0.0001). No late postoperative complications were observed between 12 and 36 months. Sexual function was stable through 3 years, with no reports of sexual or ejaculatory dysfunctions. No patients underwent alternative treatments between 24 and 36 months.
Conclusion Treatment of BPO-related LUTS with iTIND demonstrated a significant and durable reduction in symptoms and improvement of functional parameters and quality of life at 3 years of follow-up. No late postoperative complications, ejaculatory dysfunction, or additional treatment failures were observed between 24 and 36 months.
Introduction
Lower urinary tract symptoms (LUTS) secondary to benign prostatic obstruction (BPO) is one of the most common conditions which can negatively impact the quality of life of men in their lifetime. Prevalence of benign prostatic hyperplasia (BPH) that can lead to BPO starts at age 40–45 years, reaches 60% by age 60, and can be as much as 80% by age 80 [1].
Treatment for reducing LUTS secondary to BPO often begins with watchful waiting and implementation of lifestyle changes, and then progresses to pharmaceutical therapy with the use of selective alpha-blockers, with or without 5-alpha reductase inhibitors [2, 3]. Despite pharmaceutical therapy being considered the first line of treatment, many patients are unhappy with the level of symptomatic relief it offers, or are bothered by treatment-induced side effects, such as dizziness and sexual dysfunction. For this reason, treatment compliance is low, with only ~29–30% of patients adhering to treatment during the first 12 months [3, 4].
The gold standard surgical treatment for BPH today is trans-urethral resection of the prostate (TURP), which offers a significant and durable reduction in symptoms and an increase in urinary flow. However, TURP is also associated with a 20% morbidity rate, including urinary incontinence (3%), bleeding requiring blood transfusion (2.9%), urethral stricture (7%), TUR syndrome (1.4%), erectile dysfunction (10%) and retrograde ejaculation (65%) [5–7].
New, laser-based ablative techniques, while also effective in providing relief of BPH-related symptoms, still present complications similar to those seen with TURP [7–9].
The temporary implantable nitinol device was developed to offer an effective and minimally invasive alternative for treating LUTS due to BPO through the use of a temporarily implanted device. The device, left in place for only 5–7 days, remodels the prostatic urethra and bladder neck through ischemic pressure, effectively relieving the obstruction to the bladder outlet without ablating or resecting tissue, and without leaving a permanent implant in the body.
In the first-in-man, 3-year clinical study of the first-generation device (TIND; Medi-Tate Ltd., Israel), and in the multicenter, prospective analysis of the 1 and 2 years performance of the second-generation device (iTIND), this minimally invasive approach demonstrated safety and effectiveness leading to significant and stable relief of BPO associated LUTS as measured by IPSS, QoL, and improved functional results [10–13].
The aim of the present study is to report on the outcomes of patients 3 years after treatment with iTIND.
Conclusion
Treatment of BPO-related LUTS with the second-generation temporary implantable nitinol device demonstrated a significant and durable reduction in symptoms and improvement in functional parameters and quality of life at 3 years of follow-up. As for the first-generation device, no late postoperative complications were observed between 12 and 36 months. No impact on ejaculatory function and a low, total, and cumulative (8.6%) treatment failure rate from baseline to 3 years was recorded.
Last edited:
