madman
Super Moderator
Abstract
Purpose To review and discuss the literature regarding iTIND, Urolift, and Rezūm and investigate the precise clinical indications of all three different approaches for their application in benign prostatic hyperplasia (BPH) treatment.
Materials and methods The PubMed–Medline and Cochrane Library databases were screened to identify recent English literature relevant to iTIND, Urolift, and Rezūm therapies. The surgical technique and clinical results for each approach were summarized narratively.
Results iTIND, Urolift, and Rezūm are safe and effective minimally invasive procedures for the symptomatic relief of lower urinary tract symptoms (LUTS) due to BPH. iTIND requires the results of ongoing prospective studies, a long-term follow-up, and a comparison against a reference technique to confirm the generalizability of the first pivotal study. Urolift provides symptomatic relief but the improvements are inferior to TURP at 24 months and long-term retreatments have not been evaluated. Rezūm requires randomized controlled trials against a reference technique to confirm the first promising clinical results. However, clinical evidence from prospective clinical trials demonstrates the efficacy and safety of these procedures in patients with small- and medium-sized prostates.
Conclusions Although iTIND, Urolift, and Rezūm cannot be applied to all bladder outlet obstruction (BOO) cases resulting from BPH, they provide a safe alternative for carefully selected patients who desire symptom relief and preservation of erectile and ejaculatory function without the potential morbidity of more invasive procedures.
Introduction
Benign prostatic hyperplasia (BPH) is a common ailment in urologic practice affecting up to 30% of men over 50 years [1, 2]. BPH causes physical compression of the urethra and results in bladder outlet obstruction (BOO) either through an increase in prostate volume or an increase in smooth muscle tone and is clinically characterized by lower urinary tract symptoms (LUTS) [3]. LUTS are known to substantially diminish patient’s health-related quality of life and are of significant socio-economic importance to public health systems worldwide considering the changing demographic landscape [4, 5].
Existing therapeutic strategies range from observation, medical treatment to a variety of surgical treatment modalities. Surgical intervention is appropriate in patients who failed medical treatment, present with moderate-to-severe LUTS, and have developed BPH-related complications such as urinary retention, bladder stones, recurrent urinary tract infections, and renal failure. Traditionally, transurethral resection of the prostate (TURP) has been the treatment method of choice and is still recommended in most national and international guidelines as the gold-standard for gland sizes of up to 80 cc. However, TURP is accompanied by a substantial perioperative morbidity rate of up to 20% [6] and postoperative complications include anejaculation (65%), erectile dysfunction (10%), urethral strictures (7%), and incontinence (3%) [7]. While the development of transurethral enucleation techniques using different energy sources such as holmium and thulium lasers have led to the replacement of simple prostatectomy and have become the standard for larger gland sizes, wherever the techniques are available, TURP is still applied to small and medium-size prostatic adenomas in most urological centers. Therefore, newer minimally invasive procedures (MIS) strive to rival standard BPH interventions by providing durable outcome efficacy and improved safety profiles.
In this study, we describe three promising minimally invasive treatment modalities (iTIND, Urolift, and Rezūm) and review the current literature regarding their safety, functional outcome efficacy, and indications to be implemented in BPH treatment.
Temporary implantable nitinol device (iTIND)
Surgical technique
Clinical results
EAU guideline summary of evidence and recommendations
• No EAU recommendation since the technique is under investigation requiring RCTs against a reference technique. Secondary studies are needed to confirm the reproducibility and generalizability of the first pivotal study [25].
AUA guideline statement
• Technique not included in AUA guideline
Prostatic urethral lift (Urolift)
Surgical technique
Clinical results
EAU guideline summary of evidence and recommendations
• PUL improves IPSS, Qmax, and QoL; however, these improvements are inferior to TURP at 24 months (level of evidence (LE), 1b) [25].
• PUL has a low incidence of sexual side effects (LE, 1b) [25].
• Patients should be informed that long-term effects including the risk of retreatment have not been evaluated (LE, 4) [25].
• Ofer PUL (Urolift) to men with LUTS interested in preserving ejaculatory function, with prostates<70 mL and no middle lobe (Strong recommendation) [25]
AUA guideline statements
• PUL may be offered as an option for patients with LUTS attributed to BPH provided prostate volume<80 g and verified the absence of an obstructive middle lobe (Moderate recommendation; LE Grade C) [28].
• PUL may be offered to eligible patients who desire the preservation of erectile and ejaculatory function (Conditional recommendation; LE Grade C) [28].
Water vapor thermal therapy (Rezūm)
Surgical technique
Clinical results
EAU guideline summary of evidence and recommendations
• No EAU recommendation since the technique is under investigation requiring RCTs against a reference technique to confirm the first promising clinical results and to evaluate mid- and long-term efficacy and safety [25].
AUA guideline statements
• Rezūm may be offered to patients with LUTS attributed to BPH provided prostate volume<80 g (Moderate recommendation; LE Grade C) [28]. • Rezūm may be offered to eligible patients who desire the preservation of erectile and ejaculatory function (Conditional recommendation; LE Grade C) [28].
Conclusion
The successful outcomes observed in the iTIND, PUL, and Rezūm studies for the treatment of LUTS resulting from BPH is a stepping stone towards the further adoption of such minimally invasive procedures aiming to guarantee a short recovery time and return to normal activity while also maintaining sexual and ejaculatory functions intact. However, longer follow-up and the results of ongoing clinical trials are required to verify whether their advantages are sufficient to convince practitioners, patients, and insurers to ensure their long-term usage and applicability in daily clinical practice.
Purpose To review and discuss the literature regarding iTIND, Urolift, and Rezūm and investigate the precise clinical indications of all three different approaches for their application in benign prostatic hyperplasia (BPH) treatment.
Materials and methods The PubMed–Medline and Cochrane Library databases were screened to identify recent English literature relevant to iTIND, Urolift, and Rezūm therapies. The surgical technique and clinical results for each approach were summarized narratively.
Results iTIND, Urolift, and Rezūm are safe and effective minimally invasive procedures for the symptomatic relief of lower urinary tract symptoms (LUTS) due to BPH. iTIND requires the results of ongoing prospective studies, a long-term follow-up, and a comparison against a reference technique to confirm the generalizability of the first pivotal study. Urolift provides symptomatic relief but the improvements are inferior to TURP at 24 months and long-term retreatments have not been evaluated. Rezūm requires randomized controlled trials against a reference technique to confirm the first promising clinical results. However, clinical evidence from prospective clinical trials demonstrates the efficacy and safety of these procedures in patients with small- and medium-sized prostates.
Conclusions Although iTIND, Urolift, and Rezūm cannot be applied to all bladder outlet obstruction (BOO) cases resulting from BPH, they provide a safe alternative for carefully selected patients who desire symptom relief and preservation of erectile and ejaculatory function without the potential morbidity of more invasive procedures.
Introduction
Benign prostatic hyperplasia (BPH) is a common ailment in urologic practice affecting up to 30% of men over 50 years [1, 2]. BPH causes physical compression of the urethra and results in bladder outlet obstruction (BOO) either through an increase in prostate volume or an increase in smooth muscle tone and is clinically characterized by lower urinary tract symptoms (LUTS) [3]. LUTS are known to substantially diminish patient’s health-related quality of life and are of significant socio-economic importance to public health systems worldwide considering the changing demographic landscape [4, 5].
Existing therapeutic strategies range from observation, medical treatment to a variety of surgical treatment modalities. Surgical intervention is appropriate in patients who failed medical treatment, present with moderate-to-severe LUTS, and have developed BPH-related complications such as urinary retention, bladder stones, recurrent urinary tract infections, and renal failure. Traditionally, transurethral resection of the prostate (TURP) has been the treatment method of choice and is still recommended in most national and international guidelines as the gold-standard for gland sizes of up to 80 cc. However, TURP is accompanied by a substantial perioperative morbidity rate of up to 20% [6] and postoperative complications include anejaculation (65%), erectile dysfunction (10%), urethral strictures (7%), and incontinence (3%) [7]. While the development of transurethral enucleation techniques using different energy sources such as holmium and thulium lasers have led to the replacement of simple prostatectomy and have become the standard for larger gland sizes, wherever the techniques are available, TURP is still applied to small and medium-size prostatic adenomas in most urological centers. Therefore, newer minimally invasive procedures (MIS) strive to rival standard BPH interventions by providing durable outcome efficacy and improved safety profiles.
In this study, we describe three promising minimally invasive treatment modalities (iTIND, Urolift, and Rezūm) and review the current literature regarding their safety, functional outcome efficacy, and indications to be implemented in BPH treatment.
Temporary implantable nitinol device (iTIND)
Surgical technique
Clinical results
EAU guideline summary of evidence and recommendations
• No EAU recommendation since the technique is under investigation requiring RCTs against a reference technique. Secondary studies are needed to confirm the reproducibility and generalizability of the first pivotal study [25].
AUA guideline statement
• Technique not included in AUA guideline
Prostatic urethral lift (Urolift)
Surgical technique
Clinical results
EAU guideline summary of evidence and recommendations
• PUL improves IPSS, Qmax, and QoL; however, these improvements are inferior to TURP at 24 months (level of evidence (LE), 1b) [25].
• PUL has a low incidence of sexual side effects (LE, 1b) [25].
• Patients should be informed that long-term effects including the risk of retreatment have not been evaluated (LE, 4) [25].
• Ofer PUL (Urolift) to men with LUTS interested in preserving ejaculatory function, with prostates<70 mL and no middle lobe (Strong recommendation) [25]
AUA guideline statements
• PUL may be offered as an option for patients with LUTS attributed to BPH provided prostate volume<80 g and verified the absence of an obstructive middle lobe (Moderate recommendation; LE Grade C) [28].
• PUL may be offered to eligible patients who desire the preservation of erectile and ejaculatory function (Conditional recommendation; LE Grade C) [28].
Water vapor thermal therapy (Rezūm)
Surgical technique
Clinical results
EAU guideline summary of evidence and recommendations
• No EAU recommendation since the technique is under investigation requiring RCTs against a reference technique to confirm the first promising clinical results and to evaluate mid- and long-term efficacy and safety [25].
AUA guideline statements
• Rezūm may be offered to patients with LUTS attributed to BPH provided prostate volume<80 g (Moderate recommendation; LE Grade C) [28]. • Rezūm may be offered to eligible patients who desire the preservation of erectile and ejaculatory function (Conditional recommendation; LE Grade C) [28].
Conclusion
The successful outcomes observed in the iTIND, PUL, and Rezūm studies for the treatment of LUTS resulting from BPH is a stepping stone towards the further adoption of such minimally invasive procedures aiming to guarantee a short recovery time and return to normal activity while also maintaining sexual and ejaculatory functions intact. However, longer follow-up and the results of ongoing clinical trials are required to verify whether their advantages are sufficient to convince practitioners, patients, and insurers to ensure their long-term usage and applicability in daily clinical practice.
