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THE PROSTATIC URETHRAL LIFT: A NOVEL MINIMALLY INVASIVE TREATMENT FOR LOWER URINARY TRACT SYMPTOMS SECONDARY TO BENIGN PROSTATIC HYPERPLASIA
THE JOURNAL OF UROLOGY®
Vol. 181, No. 4, Supplement, Wednesday, April 29, 2009
699
1933
1934
PRELIMINARY RESULTS FROM AN INTERNATIONAL MULTICENTER BLINDED RANDOMIZED CLINICAL TRIAL COMPARING BIPOLAR WITH MONOPOLAR TRANSURETHRAL RESECTION OF THE PROSTATE
THE PROSTATIC URETHRAL LIFT: A NOVEL MINIMALLY INVASIVE TREATMENT FOR LOWER URINARY TRACT SYMPTOMS SECONDARY TO BENIGN PROSTATIC HYPERPLASIA
M. Schulze*, Heidelberg, Germany; C. Mamoulakis, J. Rioja, Amsterdam, Netherlands; A. Skolarikos, Athens, Greece; Jens Rassweiler, Heidelberg, Germany; G. Alivizatios, Athens, Greece; Jean de la Rosette, Amsterdam, Netherlands
Henry H Woo*, Sydney, Australia; Peter T Chin, Wollongong, Australia; Thomas A McNicholas, Stevenage, United Kingdom; Harcharan S Gill, Palo Alto, CA; Mark K Plante, Burlington, VT; Claus G Roehrborn, Dallas, TX
INTRODUCTION AND OBJECTIVES: Evidence from several single-center randomized clinical trials (RCT) suggests that the incorporation of bipolar technology in TURP is a promising technical modification. Results from an international multicenter blinded RCT comparing conventional monopolar with bipolar TURP are presented for the first time. METHODS: In this on-going study, patients with symptomatic benign prostate hyperplasia are enrolled in Germany, Greece, Italy and the Netherlands. Patients are double-blindly and randomly assigned either to the monopolar or the bipolar arm. The bipolar Karl Storz® resectoscope (24 F) and the AUTOCON Electrosurgical Unit are uniformly used. Results on this bipolar system are reported for the first time in terms of a RCT. One experienced urologist performs all procedures in each center. Data on a total of 214 patients (monopolar arm; n=110, bipolar arm; n=104) from three European centers were available at the time of this preliminary analysis. Operation time, resection time, resection weight, resection rate and time to catheter removal were compared between arms, in the total population and among centers, with the use of non-parametric statistical tests. A probability P<0.05 was used to define statistical significance. RESULTS: Patients’ baseline characteristics (age, prostate volume, maximum flow rate, International Prostate Symptom Score, quality of life score and post-void residual urine) did not differ significantly between arms. No statistically significant differences regarding the variables of interest were detected between arms either in the total population or among centers. Results are presented as median (range) and are summarized in table 1. Table 1. Results Monopolar TURP All centers Germany Operation 50 (21-100) Time (min)
49 (28100)
Resection Time (min)
38 (16-87) 40 (20-87)
Resection Weight (g)
30 (4-125)
38 (15125)
Greece 50 (3570)
Bipolar TURP Netherlands
All centers Germany Greece Netherlands
53 (21-80)
50 (3550 (12-85) 43 (19-84) 70)
59 (12-85)
35 (2060)
47 (16-72)
35 (10-77) 36 (12-75)
35 (2050)
35 (10-85)
20 (1040)
31 (4-71)
20 (1040)
22 (4-60)
Resection Rate (g/min)
0.7 (0.22.0)
1.0 (0.62.0)
0.5 (0.31.6)
0.7 (0.2-1.3)
Time to catheter removal (days)
3.0 (1.08.0)
3.5 (2.08.0)
4.0 (3.06.0)
2.0 (1.0-3.0)
INTRODUCTION AND OBJECTIVES: Many patients with LUTS secondary to BPH are dissatisfied with currently available pharmacotherapy and procedural treatments. They would benefit from a procedure that could improve symptoms without the morbidities associated with thermal therapies or transurethral resection (TURP). We report on the first human experience with the Prostatic Urethral Lift, a tissue sparing, minimally invasive transurethral procedure that shows promise for the treatment of LUTS secondary to BPH. METHODS: A nonrandomized prospective cohort of 19 TURP candidates underwent lift treatment (mean age 66; mean AUA SI 22.6; prostate volume range: 21 - 97 cc). Small, suture-based tissue retainers were implanted transurethrally to retract obstructing prostatic lobes thereby expanding the urethral lumen. Safety and feasibility were assessed by observation of adverse events and procedural completion rate, while effectiveness parameters included the American Urological Association Symptom Index (AUA SI), quality of life (QOL) score, and BPH Impact Index (BPH II). Additional parameters were recorded, including procedure time, flow rate, post void residual volume, and sexual health. RESULTS: The procedure was performed successfully in all patients with no serious adverse events. As a first human experience all procedures were conducted with patients under general anesthesia. Modest dysuria, hematuria or urgency occurred in some patients and typically resolved within a week. At the two week follow-up, there was considerable improvement from baseline, and these improvements in symptoms were broadly sustained through 12 months. CONCLUSIONS: The Prostatic Urethral Lift appears to be a safe and feasible procedure for the treatment of LUTS secondary to BPH. This procedure is straight forward to perform, and data suggest a favorable effectiveness profile with rapid onset and durability to at least 12 months. This novel, tissue-sparing approach warrants further study in a larger series, and a multi-center randomized study is now planned.
25 (4-70) 39 (12-70)
0.8 (0.3-2) 1.0 (0.4-2)
3 (1-12)
Baseline 2 weeks 2 weeks 6 months 6 months Mean (SD
AUA SI 22.6(5.5) 13.8(6.5)
p-value*
Mean (SD)
1 year
1 year
p-value*
Mean (SD)
p-value*
<0.01
10.5(7.4)
<0.01
10.8(8.0)
<0.01
4.8(1.1)
2.8(2.0)
<0.01
2.1(1.4)
<0.01
2.2(1.3)
<0.01
BPH II 7.6(4.3)
3.9(4.5)
ns
2.8(3.4)
<0.05
1.7(1.6)
<0.05
QOL
*p values for changes from baseline
0.6 (0.30.7 (0.3-1.1) 1.6)
3.0 (2.0- 4.0 (2.04.0) 5.0)
Mean (SD)
Source of Funding: NeoTract, Inc.
2.0 (1.012.0)
1935 All differences between arms are not significant
CONCLUSIONS: Preliminary results from this multicenter international RCT suggest that the two methods are equivalent in experienced hands regarding operative characteristics and catheterization time. Source of Funding: None
SINGLE-PORT TRANSVESICAL ENUCLEATION OF THE PROSTATE (STEP): CLINICAL EXPERIENCE Mihir M Desai*, Andre Berger, Monish Aron, Cleveland, OH; David Canes, Burlington, MA; Robert J Stein, Ricardo Brandina, Brian Irwin, Cleveland, OH; Rene J Sotelo, Oswaldo J Carmona, Juan C Astigueta, Robert J De Andrade, Calkins Herrera, Caracas, Venezuela; James Ulchaker, Cleveland, OH; Mahesh Desai, Nadiad, India; Daniel A Shoskes, Khaled Fareed, Inderbir S Gill, Cleveland, OH INTRODUCTION AND OBJECTIVES: We report our initial experience with a novel technique-single-port transvesical enucleation of the prostate (STEP) in 30 patients with symptomatic large volume BPH. METHODS: The STEP procedure was performed in 30 patients with symptomatic large volume BPH (TRUS volume > 80 grams). A novel single-port device (r-Port, Advanced Surgical Concepts, Ireland) was inserted percutaneously into the bladder through a 2.5 cm suprapubic incision under cystoscopic control. After establishing pneumovesicum,
Vol. 181, No. 4, Supplement, Wednesday, April 29, 2009
699
1933
1934
PRELIMINARY RESULTS FROM AN INTERNATIONAL MULTICENTER BLINDED RANDOMIZED CLINICAL TRIAL COMPARING BIPOLAR WITH MONOPOLAR TRANSURETHRAL RESECTION OF THE PROSTATE
THE PROSTATIC URETHRAL LIFT: A NOVEL MINIMALLY INVASIVE TREATMENT FOR LOWER URINARY TRACT SYMPTOMS SECONDARY TO BENIGN PROSTATIC HYPERPLASIA
M. Schulze*, Heidelberg, Germany; C. Mamoulakis, J. Rioja, Amsterdam, Netherlands; A. Skolarikos, Athens, Greece; Jens Rassweiler, Heidelberg, Germany; G. Alivizatios, Athens, Greece; Jean de la Rosette, Amsterdam, Netherlands
Henry H Woo*, Sydney, Australia; Peter T Chin, Wollongong, Australia; Thomas A McNicholas, Stevenage, United Kingdom; Harcharan S Gill, Palo Alto, CA; Mark K Plante, Burlington, VT; Claus G Roehrborn, Dallas, TX
INTRODUCTION AND OBJECTIVES: Evidence from several single-center randomized clinical trials (RCT) suggests that the incorporation of bipolar technology in TURP is a promising technical modification. Results from an international multicenter blinded RCT comparing conventional monopolar with bipolar TURP are presented for the first time. METHODS: In this on-going study, patients with symptomatic benign prostate hyperplasia are enrolled in Germany, Greece, Italy and the Netherlands. Patients are double-blindly and randomly assigned either to the monopolar or the bipolar arm. The bipolar Karl Storz® resectoscope (24 F) and the AUTOCON Electrosurgical Unit are uniformly used. Results on this bipolar system are reported for the first time in terms of a RCT. One experienced urologist performs all procedures in each center. Data on a total of 214 patients (monopolar arm; n=110, bipolar arm; n=104) from three European centers were available at the time of this preliminary analysis. Operation time, resection time, resection weight, resection rate and time to catheter removal were compared between arms, in the total population and among centers, with the use of non-parametric statistical tests. A probability P<0.05 was used to define statistical significance. RESULTS: Patients’ baseline characteristics (age, prostate volume, maximum flow rate, International Prostate Symptom Score, quality of life score and post-void residual urine) did not differ significantly between arms. No statistically significant differences regarding the variables of interest were detected between arms either in the total population or among centers. Results are presented as median (range) and are summarized in table 1. Table 1. Results Monopolar TURP All centers Germany Operation 50 (21-100) Time (min)
49 (28100)
Resection Time (min)
38 (16-87) 40 (20-87)
Resection Weight (g)
30 (4-125)
38 (15125)
Greece 50 (3570)
Bipolar TURP Netherlands
All centers Germany Greece Netherlands
53 (21-80)
50 (3550 (12-85) 43 (19-84) 70)
59 (12-85)
35 (2060)
47 (16-72)
35 (10-77) 36 (12-75)
35 (2050)
35 (10-85)
20 (1040)
31 (4-71)
20 (1040)
22 (4-60)
Resection Rate (g/min)
0.7 (0.22.0)
1.0 (0.62.0)
0.5 (0.31.6)
0.7 (0.2-1.3)
Time to catheter removal (days)
3.0 (1.08.0)
3.5 (2.08.0)
4.0 (3.06.0)
2.0 (1.0-3.0)
INTRODUCTION AND OBJECTIVES: Many patients with LUTS secondary to BPH are dissatisfied with currently available pharmacotherapy and procedural treatments. They would benefit from a procedure that could improve symptoms without the morbidities associated with thermal therapies or transurethral resection (TURP). We report on the first human experience with the Prostatic Urethral Lift, a tissue sparing, minimally invasive transurethral procedure that shows promise for the treatment of LUTS secondary to BPH. METHODS: A nonrandomized prospective cohort of 19 TURP candidates underwent lift treatment (mean age 66; mean AUA SI 22.6; prostate volume range: 21 - 97 cc). Small, suture-based tissue retainers were implanted transurethrally to retract obstructing prostatic lobes thereby expanding the urethral lumen. Safety and feasibility were assessed by observation of adverse events and procedural completion rate, while effectiveness parameters included the American Urological Association Symptom Index (AUA SI), quality of life (QOL) score, and BPH Impact Index (BPH II). Additional parameters were recorded, including procedure time, flow rate, post void residual volume, and sexual health. RESULTS: The procedure was performed successfully in all patients with no serious adverse events. As a first human experience all procedures were conducted with patients under general anesthesia. Modest dysuria, hematuria or urgency occurred in some patients and typically resolved within a week. At the two week follow-up, there was considerable improvement from baseline, and these improvements in symptoms were broadly sustained through 12 months. CONCLUSIONS: The Prostatic Urethral Lift appears to be a safe and feasible procedure for the treatment of LUTS secondary to BPH. This procedure is straight forward to perform, and data suggest a favorable effectiveness profile with rapid onset and durability to at least 12 months. This novel, tissue-sparing approach warrants further study in a larger series, and a multi-center randomized study is now planned.
25 (4-70) 39 (12-70)
0.8 (0.3-2) 1.0 (0.4-2)
3 (1-12)
Baseline 2 weeks 2 weeks 6 months 6 months Mean (SD
AUA SI 22.6(5.5) 13.8(6.5)
p-value*
Mean (SD)
1 year
1 year
p-value*
Mean (SD)
p-value*
<0.01
10.5(7.4)
<0.01
10.8(8.0)
<0.01
4.8(1.1)
2.8(2.0)
<0.01
2.1(1.4)
<0.01
2.2(1.3)
<0.01
BPH II 7.6(4.3)
3.9(4.5)
ns
2.8(3.4)
<0.05
1.7(1.6)
<0.05
QOL
*p values for changes from baseline
0.6 (0.30.7 (0.3-1.1) 1.6)
3.0 (2.0- 4.0 (2.04.0) 5.0)
Mean (SD)
Source of Funding: NeoTract, Inc.
2.0 (1.012.0)
1935 All differences between arms are not significant
CONCLUSIONS: Preliminary results from this multicenter international RCT suggest that the two methods are equivalent in experienced hands regarding operative characteristics and catheterization time. Source of Funding: None
SINGLE-PORT TRANSVESICAL ENUCLEATION OF THE PROSTATE (STEP): CLINICAL EXPERIENCE Mihir M Desai*, Andre Berger, Monish Aron, Cleveland, OH; David Canes, Burlington, MA; Robert J Stein, Ricardo Brandina, Brian Irwin, Cleveland, OH; Rene J Sotelo, Oswaldo J Carmona, Juan C Astigueta, Robert J De Andrade, Calkins Herrera, Caracas, Venezuela; James Ulchaker, Cleveland, OH; Mahesh Desai, Nadiad, India; Daniel A Shoskes, Khaled Fareed, Inderbir S Gill, Cleveland, OH INTRODUCTION AND OBJECTIVES: We report our initial experience with a novel technique-single-port transvesical enucleation of the prostate (STEP) in 30 patients with symptomatic large volume BPH. METHODS: The STEP procedure was performed in 30 patients with symptomatic large volume BPH (TRUS volume > 80 grams). A novel single-port device (r-Port, Advanced Surgical Concepts, Ireland) was inserted percutaneously into the bladder through a 2.5 cm suprapubic incision under cystoscopic control. After establishing pneumovesicum,