Safety and feasibility of the prostatic urethral lift: a novel, minimally invasive treatment for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH)

Study Type – Therapy (case series) 
Level of Evidence 4 What’s known on the subject? and What does the study add? Most surgical treatments for benign prostatic hyperplasia procedural involve the removal or destruction of prostate tissue and these approaches are commonly associated with treatment rel...

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Veröffentlicht in:BJU international 2011-07, Vol.108 (1), p.82-88
Hauptverfasser: Woo, Henry H., Chin, Peter T., McNicholas, Thomas A., Gill, Harcharan S., Plante, Mark K., Bruskewitz, Reginald C., Roehrborn, Claus G.
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container_issue 1
container_start_page 82
container_title BJU international
container_volume 108
creator Woo, Henry H.
Chin, Peter T.
McNicholas, Thomas A.
Gill, Harcharan S.
Plante, Mark K.
Bruskewitz, Reginald C.
Roehrborn, Claus G.
description Study Type – Therapy (case series) 
Level of Evidence 4 What’s known on the subject? and What does the study add? Most surgical treatments for benign prostatic hyperplasia procedural involve the removal or destruction of prostate tissue and these approaches are commonly associated with treatment related morbidity. Unlike the other therapies, the prostatic urethral lift mechanically opens the prostatic urethra using tensioned sutures that compress prostate tissue between the urethra and prostate capsule. This is the first publication on this technology. This manuscript reports and confirms its safety and feasibility as a minimally invasive surgical treatment for symptomatic benign prostatic hyperplasia to justify further clinical evaluation. OBJECTIVES • To investigate the Prostatic Urethral Lift (PUL) procedure, a novel, minimally invasive treatment for symptomatic benign prostatic hyperplasia (BPH), which aims to mechanically open the prostatic urethra without ablation or resection. • To demonstrate the safety and feasibility of this procedure and to make an initial assessment of effectiveness. PATIENTS AND METHODS • The PULprocedure was performed on 19 men in Australia. • Small suture‐based implants were implanted transurethrally under cystoscopic visualisation to separate encroaching lateral prostatic lobes. • Patients were evaluated at 2 weeks and 3, 6, and 12 months after PUL. RESULTS • All cases were successfully completed with no serious or unexpected adverse events (AEs). • Between two and five sutures were delivered in each patient and the prostatic urethral lumen was visually increased in all patients. • Reported postoperative AEs were typically mild and transient and included dysuria and haematuria. • Follow‐up cystoscopy at 6 months in a subset of patients showed no calcification. Histological findings from two of three patients who progressed to transurethral resection of the prostate for return of symptoms showed no evidence of inflammation related to the implanted materials. • The mean International Prostate Symptom Score was reduced by 37% at 2 weeks and 39% at 1 year after PUL as compared with baseline. CONCLUSIONS • We demonstrated in this initial experience that the PUL procedure is safe and feasible. • The safety profile of the PUL procedure appears favourable; most patients reported sustained symptom relief to 12 months with minimal morbidity • PUL therefore warrants further study as a new option for the many patients who seek an alter
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Level of Evidence 4 What’s known on the subject? and What does the study add? Most surgical treatments for benign prostatic hyperplasia procedural involve the removal or destruction of prostate tissue and these approaches are commonly associated with treatment related morbidity. Unlike the other therapies, the prostatic urethral lift mechanically opens the prostatic urethra using tensioned sutures that compress prostate tissue between the urethra and prostate capsule. This is the first publication on this technology. This manuscript reports and confirms its safety and feasibility as a minimally invasive surgical treatment for symptomatic benign prostatic hyperplasia to justify further clinical evaluation. OBJECTIVES • To investigate the Prostatic Urethral Lift (PUL) procedure, a novel, minimally invasive treatment for symptomatic benign prostatic hyperplasia (BPH), which aims to mechanically open the prostatic urethra without ablation or resection. • To demonstrate the safety and feasibility of this procedure and to make an initial assessment of effectiveness. PATIENTS AND METHODS • The PULprocedure was performed on 19 men in Australia. • Small suture‐based implants were implanted transurethrally under cystoscopic visualisation to separate encroaching lateral prostatic lobes. • Patients were evaluated at 2 weeks and 3, 6, and 12 months after PUL. RESULTS • All cases were successfully completed with no serious or unexpected adverse events (AEs). • Between two and five sutures were delivered in each patient and the prostatic urethral lumen was visually increased in all patients. • Reported postoperative AEs were typically mild and transient and included dysuria and haematuria. • Follow‐up cystoscopy at 6 months in a subset of patients showed no calcification. Histological findings from two of three patients who progressed to transurethral resection of the prostate for return of symptoms showed no evidence of inflammation related to the implanted materials. • The mean International Prostate Symptom Score was reduced by 37% at 2 weeks and 39% at 1 year after PUL as compared with baseline. 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Urinary tract diseases ; prostate ; Prostatic Hyperplasia - complications ; Prostatic Hyperplasia - surgery ; prostatic urethral lift (PUL) ; Prostatism - etiology ; Prostatism - surgery ; Suture Techniques - adverse effects ; Treatment Outcome ; Tumors of the urinary system ; urethra ; Urethra - surgery ; Urinary system involvement in other diseases. Miscellaneous ; Urinary tract. Prostate gland</subject><ispartof>BJU international, 2011-07, Vol.108 (1), p.82-88</ispartof><rights>2011 THE AUTHORS. BJU INTERNATIONAL © 2011 BJU INTERNATIONAL</rights><rights>2015 INIST-CNRS</rights><rights>2011 THE AUTHORS. 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Level of Evidence 4 What’s known on the subject? and What does the study add? Most surgical treatments for benign prostatic hyperplasia procedural involve the removal or destruction of prostate tissue and these approaches are commonly associated with treatment related morbidity. Unlike the other therapies, the prostatic urethral lift mechanically opens the prostatic urethra using tensioned sutures that compress prostate tissue between the urethra and prostate capsule. This is the first publication on this technology. This manuscript reports and confirms its safety and feasibility as a minimally invasive surgical treatment for symptomatic benign prostatic hyperplasia to justify further clinical evaluation. OBJECTIVES • To investigate the Prostatic Urethral Lift (PUL) procedure, a novel, minimally invasive treatment for symptomatic benign prostatic hyperplasia (BPH), which aims to mechanically open the prostatic urethra without ablation or resection. • To demonstrate the safety and feasibility of this procedure and to make an initial assessment of effectiveness. PATIENTS AND METHODS • The PULprocedure was performed on 19 men in Australia. • Small suture‐based implants were implanted transurethrally under cystoscopic visualisation to separate encroaching lateral prostatic lobes. • Patients were evaluated at 2 weeks and 3, 6, and 12 months after PUL. RESULTS • All cases were successfully completed with no serious or unexpected adverse events (AEs). • Between two and five sutures were delivered in each patient and the prostatic urethral lumen was visually increased in all patients. • Reported postoperative AEs were typically mild and transient and included dysuria and haematuria. • Follow‐up cystoscopy at 6 months in a subset of patients showed no calcification. Histological findings from two of three patients who progressed to transurethral resection of the prostate for return of symptoms showed no evidence of inflammation related to the implanted materials. • The mean International Prostate Symptom Score was reduced by 37% at 2 weeks and 39% at 1 year after PUL as compared with baseline. CONCLUSIONS • We demonstrated in this initial experience that the PUL procedure is safe and feasible. • The safety profile of the PUL procedure appears favourable; most patients reported sustained symptom relief to 12 months with minimal morbidity • PUL therefore warrants further study as a new option for the many patients who seek an alternative to current therapies.</description><subject>Aged</subject><subject>Australia</subject><subject>benign prostatic hyperplasia</subject><subject>Biological and medical sciences</subject><subject>Cystoscopy</subject><subject>Feasibility Studies</subject><subject>Humans</subject><subject>LUTS</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>minimally invasive surgical therapy</subject><subject>Nephrology. Urinary tract diseases</subject><subject>prostate</subject><subject>Prostatic Hyperplasia - complications</subject><subject>Prostatic Hyperplasia - surgery</subject><subject>prostatic urethral lift (PUL)</subject><subject>Prostatism - etiology</subject><subject>Prostatism - surgery</subject><subject>Suture Techniques - adverse effects</subject><subject>Treatment Outcome</subject><subject>Tumors of the urinary system</subject><subject>urethra</subject><subject>Urethra - surgery</subject><subject>Urinary system involvement in other diseases. Miscellaneous</subject><subject>Urinary tract. 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Urinary tract diseases</topic><topic>prostate</topic><topic>Prostatic Hyperplasia - complications</topic><topic>Prostatic Hyperplasia - surgery</topic><topic>prostatic urethral lift (PUL)</topic><topic>Prostatism - etiology</topic><topic>Prostatism - surgery</topic><topic>Suture Techniques - adverse effects</topic><topic>Treatment Outcome</topic><topic>Tumors of the urinary system</topic><topic>urethra</topic><topic>Urethra - surgery</topic><topic>Urinary system involvement in other diseases. Miscellaneous</topic><topic>Urinary tract. Prostate gland</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Woo, Henry H.</creatorcontrib><creatorcontrib>Chin, Peter T.</creatorcontrib><creatorcontrib>McNicholas, Thomas A.</creatorcontrib><creatorcontrib>Gill, Harcharan S.</creatorcontrib><creatorcontrib>Plante, Mark K.</creatorcontrib><creatorcontrib>Bruskewitz, Reginald C.</creatorcontrib><creatorcontrib>Roehrborn, Claus G.</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>BJU international</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Woo, Henry H.</au><au>Chin, Peter T.</au><au>McNicholas, Thomas A.</au><au>Gill, Harcharan S.</au><au>Plante, Mark K.</au><au>Bruskewitz, Reginald C.</au><au>Roehrborn, Claus G.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety and feasibility of the prostatic urethral lift: a novel, minimally invasive treatment for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH)</atitle><jtitle>BJU international</jtitle><addtitle>BJU Int</addtitle><date>2011-07</date><risdate>2011</risdate><volume>108</volume><issue>1</issue><spage>82</spage><epage>88</epage><pages>82-88</pages><issn>1464-4096</issn><eissn>1464-410X</eissn><abstract>Study Type – Therapy (case series) 
Level of Evidence 4 What’s known on the subject? and What does the study add? Most surgical treatments for benign prostatic hyperplasia procedural involve the removal or destruction of prostate tissue and these approaches are commonly associated with treatment related morbidity. Unlike the other therapies, the prostatic urethral lift mechanically opens the prostatic urethra using tensioned sutures that compress prostate tissue between the urethra and prostate capsule. This is the first publication on this technology. This manuscript reports and confirms its safety and feasibility as a minimally invasive surgical treatment for symptomatic benign prostatic hyperplasia to justify further clinical evaluation. OBJECTIVES • To investigate the Prostatic Urethral Lift (PUL) procedure, a novel, minimally invasive treatment for symptomatic benign prostatic hyperplasia (BPH), which aims to mechanically open the prostatic urethra without ablation or resection. • To demonstrate the safety and feasibility of this procedure and to make an initial assessment of effectiveness. PATIENTS AND METHODS • The PULprocedure was performed on 19 men in Australia. • Small suture‐based implants were implanted transurethrally under cystoscopic visualisation to separate encroaching lateral prostatic lobes. • Patients were evaluated at 2 weeks and 3, 6, and 12 months after PUL. RESULTS • All cases were successfully completed with no serious or unexpected adverse events (AEs). • Between two and five sutures were delivered in each patient and the prostatic urethral lumen was visually increased in all patients. • Reported postoperative AEs were typically mild and transient and included dysuria and haematuria. • Follow‐up cystoscopy at 6 months in a subset of patients showed no calcification. Histological findings from two of three patients who progressed to transurethral resection of the prostate for return of symptoms showed no evidence of inflammation related to the implanted materials. • The mean International Prostate Symptom Score was reduced by 37% at 2 weeks and 39% at 1 year after PUL as compared with baseline. CONCLUSIONS • We demonstrated in this initial experience that the PUL procedure is safe and feasible. • The safety profile of the PUL procedure appears favourable; most patients reported sustained symptom relief to 12 months with minimal morbidity • PUL therefore warrants further study as a new option for the many patients who seek an alternative to current therapies.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>21554526</pmid><doi>10.1111/j.1464-410X.2011.10342.x</doi><tpages>7</tpages></addata></record>
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source MEDLINE; Wiley Online Library Journals Frontfile Complete
subjects Aged
Australia
benign prostatic hyperplasia
Biological and medical sciences
Cystoscopy
Feasibility Studies
Humans
LUTS
Male
Medical sciences
Middle Aged
minimally invasive surgical therapy
Nephrology. Urinary tract diseases
prostate
Prostatic Hyperplasia - complications
Prostatic Hyperplasia - surgery
prostatic urethral lift (PUL)
Prostatism - etiology
Prostatism - surgery
Suture Techniques - adverse effects
Treatment Outcome
Tumors of the urinary system
urethra
Urethra - surgery
Urinary system involvement in other diseases. Miscellaneous
Urinary tract. Prostate gland
title Safety and feasibility of the prostatic urethral lift: a novel, minimally invasive treatment for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH)
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