madman
Super Moderator
The iTind Temporarily Implanted Nitinol Device for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Multicenter, Randomized, Controlled Trial
Abstract
Objective
To report the results of a multicenter, randomized, controlled trial with a temporarily implanted nitinol device (iTind; Medi-Tate Ltd, Hadera, Israel) compared to sham for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia.
Materials and Methods
Men 50 years or older were randomized 2:1 between iTind and sham procedure arms. A self-expanding, temporary nitinol device was placed for 5 to 7 days and an 18F Foley catheter was inserted and removed for the iTind and sham group, respectively. Patients were assessed at baseline, 1.5, 3, and 12 months postoperatively using the IPSS peak urinary flow rate (PFR), residual urine, quality of life (QoL), and the International Index of Erectile Function (IIEF). Unblinding occurred at 3 months.
Results
A total of 175 men (mean age 61.1±6.5) participated (118 iTind vs 57 shams). 78.6% of patients in the iTind arm showed a reduction of ≥3 points in IPSS, versus 60% of patients in the control arm at 3 months. At 12 months, the iTind group reported a 9.25 decrease in IPSS (p<0.0001), a 3.52ml/s increase in PFR (p<0.0001) and a 1.9-point reduction in QoL (p<0.0001). Adverse events were typically mild and transient, most Clavien-Dindo grade I or II, in 38.1% of patients in the iTind arm and 17.5% in the control arm. No de novo ejaculatory or erectile dysfunction occurred.
Conclusions
Treatment with the second-generation iTind provided rapid and sustained improvement in lower urinary tract symptoms for the study period while preserving sexual function.
INTRODUCTION
Benign prostatic hyperplasia (BPH) is often associated with bothersome lower urinary tract symptoms (LUTS) affecting 50% to 75% in men over 50, and reach up to 80% in men aged 70 years and older with adherence rates to pharmacology as low as 30% after one year due to unmet due to unmet patient expectations or bothersome side effects.1, 2, 3, 4, 5 Treatment-induced sexual dysfunction is a key concern when considering pharmaceutical therapy.3,6,7
Transurethral resection of the prostate (TURP), considered the “gold-standard” in surgical therapy for LUTS secondary to BPH, provides significant and durable relief of symptoms. However, it incurs the risk of significant post-procedural morbidity and long-term complications, including urinary incontinence (3%), strictures (7%), erectile dysfunction (10%), and loss of ejaculation (65%), and 20-50% persistent LUTS.8,9 Novel laser-based ablative modalities provide effective relief of BPH-related symptoms with a similar rate of complications as TURP.8,10
Among effective, minimally invasive alternatives for LUTS secondary to BPH treatment such as the prostatic urethral lift (PUL, UroLift System, Extract, CA, USA)11 and convective water vapor treatment (Rezum System, NxThera, Maple Grove, MN, USA), the second-generation temporarily implanted nitinol device (iTind; Medi-Tate Ltd, Hadera, Israel)11 was given de novo authorization by the Food and Drug Administration (FDA) in February 2020. Two single-arm studies have demonstrated that iTind treatment provides rapid and effective LUTS relief that is durable to 3 years, with low rates of adverse events (AEs) and preservation of sexual function.12,13 This study compares iTind to sham in the reduction of LUTS secondary to BPH.
iTind procedure
The iTind implantation has been described in previous studies.12,13 Briefly, the iTind device is comprised of three elongated, intertwined nitinol struts at the 12, 5, and 7 o'clock positions, an anti-migration anchoring leaflet at 6 o'clock, and a polyester retrieval suture for easy device removal.
The device is implanted for 5-7 days, during which it expands and exerts a radial force, creating deep ischemic incisions and remodeling on the prostate tissue at the bladder neck and anterior prostatic fossa. The iTind is deployed under direct visualization in an ambulatory procedure using a rigid cystoscopy. The device is removed through either a rigid cystoscope or an open-ended 22F Foley catheter with topical anesthesia. Both implantation and removal can be done under local, IV, or general anesthesia at the discretion of the performing physician. Catheterization is not required following either implantation or removal.
Results
*Procedure
*Efficacy
*Safety
Conclusion
iTind provides a safe, rapid, and sustained improvement in lower urinary tract symptoms to 12 months secondary to BPH in prostate volumes of 25-75cc. This minimally invasive FDA-approved procedure is effective and well-tolerated for LUTS treatment, while preserving both ejaculation and erectile function, and offers patients an attractive alternative for relief of symptomatic BPH.
Abstract
Objective
To report the results of a multicenter, randomized, controlled trial with a temporarily implanted nitinol device (iTind; Medi-Tate Ltd, Hadera, Israel) compared to sham for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia.
Materials and Methods
Men 50 years or older were randomized 2:1 between iTind and sham procedure arms. A self-expanding, temporary nitinol device was placed for 5 to 7 days and an 18F Foley catheter was inserted and removed for the iTind and sham group, respectively. Patients were assessed at baseline, 1.5, 3, and 12 months postoperatively using the IPSS peak urinary flow rate (PFR), residual urine, quality of life (QoL), and the International Index of Erectile Function (IIEF). Unblinding occurred at 3 months.
Results
A total of 175 men (mean age 61.1±6.5) participated (118 iTind vs 57 shams). 78.6% of patients in the iTind arm showed a reduction of ≥3 points in IPSS, versus 60% of patients in the control arm at 3 months. At 12 months, the iTind group reported a 9.25 decrease in IPSS (p<0.0001), a 3.52ml/s increase in PFR (p<0.0001) and a 1.9-point reduction in QoL (p<0.0001). Adverse events were typically mild and transient, most Clavien-Dindo grade I or II, in 38.1% of patients in the iTind arm and 17.5% in the control arm. No de novo ejaculatory or erectile dysfunction occurred.
Conclusions
Treatment with the second-generation iTind provided rapid and sustained improvement in lower urinary tract symptoms for the study period while preserving sexual function.
INTRODUCTION
Benign prostatic hyperplasia (BPH) is often associated with bothersome lower urinary tract symptoms (LUTS) affecting 50% to 75% in men over 50, and reach up to 80% in men aged 70 years and older with adherence rates to pharmacology as low as 30% after one year due to unmet due to unmet patient expectations or bothersome side effects.1, 2, 3, 4, 5 Treatment-induced sexual dysfunction is a key concern when considering pharmaceutical therapy.3,6,7
Transurethral resection of the prostate (TURP), considered the “gold-standard” in surgical therapy for LUTS secondary to BPH, provides significant and durable relief of symptoms. However, it incurs the risk of significant post-procedural morbidity and long-term complications, including urinary incontinence (3%), strictures (7%), erectile dysfunction (10%), and loss of ejaculation (65%), and 20-50% persistent LUTS.8,9 Novel laser-based ablative modalities provide effective relief of BPH-related symptoms with a similar rate of complications as TURP.8,10
Among effective, minimally invasive alternatives for LUTS secondary to BPH treatment such as the prostatic urethral lift (PUL, UroLift System, Extract, CA, USA)11 and convective water vapor treatment (Rezum System, NxThera, Maple Grove, MN, USA), the second-generation temporarily implanted nitinol device (iTind; Medi-Tate Ltd, Hadera, Israel)11 was given de novo authorization by the Food and Drug Administration (FDA) in February 2020. Two single-arm studies have demonstrated that iTind treatment provides rapid and effective LUTS relief that is durable to 3 years, with low rates of adverse events (AEs) and preservation of sexual function.12,13 This study compares iTind to sham in the reduction of LUTS secondary to BPH.
iTind procedure
The iTind implantation has been described in previous studies.12,13 Briefly, the iTind device is comprised of three elongated, intertwined nitinol struts at the 12, 5, and 7 o'clock positions, an anti-migration anchoring leaflet at 6 o'clock, and a polyester retrieval suture for easy device removal.
The device is implanted for 5-7 days, during which it expands and exerts a radial force, creating deep ischemic incisions and remodeling on the prostate tissue at the bladder neck and anterior prostatic fossa. The iTind is deployed under direct visualization in an ambulatory procedure using a rigid cystoscopy. The device is removed through either a rigid cystoscope or an open-ended 22F Foley catheter with topical anesthesia. Both implantation and removal can be done under local, IV, or general anesthesia at the discretion of the performing physician. Catheterization is not required following either implantation or removal.
Results
*Procedure
*Efficacy
*Safety
Conclusion
iTind provides a safe, rapid, and sustained improvement in lower urinary tract symptoms to 12 months secondary to BPH in prostate volumes of 25-75cc. This minimally invasive FDA-approved procedure is effective and well-tolerated for LUTS treatment, while preserving both ejaculation and erectile function, and offers patients an attractive alternative for relief of symptomatic BPH.
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