Adjustable bulbourethral male sling: experience after 101 cases of moderate‐to‐severe male stress urinary incontinence
Study Type – Therapy (case series) Level of Evidence 4 What’s known on the subject? and What does the study add? First data on the ARGUS® sling was published in 2006 by Romano SV et al. as a multicentre study, evaluating the data of 48 patients with a mean follow up (FU) of 7.5 months, with the conc...
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Published in | BJU international Vol. 107; no. 5; pp. 777 - 782 |
---|---|
Main Authors | , , , |
Format | Journal Article |
Language | English |
Published |
Oxford, UK
Blackwell Publishing Ltd
01.03.2011
Wiley-Blackwell Wiley Subscription Services, Inc |
Subjects | |
Online Access | Get full text |
ISSN | 1464-4096 1464-410X 1464-410X |
DOI | 10.1111/j.1464-410X.2010.09619.x |
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Abstract | Study Type – Therapy (case series)
Level of Evidence 4
What’s known on the subject? and What does the study add?
First data on the ARGUS® sling was published in 2006 by Romano SV et al. as a multicentre study, evaluating the data of 48 patients with a mean follow up (FU) of 7.5 months, with the conclusion that this new adjustable sling was effective in treatment of SUI and the complication rate was acceptable. In 2009, Romano SV et al. published a long‐term FU (mean: 45 months) of the same patient group, demonstrating the long‐term efficacy of the sling.
Our study evaluated the data of 101 cases of moderate to severe male stress urinary incontinence (SUI) after implantation of the ARGUS® sling at mean follow‐up of 2.1 (0.1–4.5) years. In addition we made a subgroup analysis of representative “index patients”, patients after external beam radiation therapy (EBRT) and of a subgroup after differentiation of the retrograde leak point pressure (RLPP).
OBJECTIVES
•
To report our experience using an adjustable bulbourethral sling since April 2005 for male stress urinary incontinence (SUI) after prostatic surgery.
•
To evaluate the safety, efficacy and health‐related quality of life in recipients of the Argus® (Promedon SA; Cordoba, Argentina) adjustable bulbourethral sling.
PATIENTS AND METHODS
•
Between April 2005 and April 2009, 101 men with moderate‐to‐severe SUI after prostatic surgery were implanted with the Argus sling.
•
The radio‐opaque Argus system comprises a thick silicone‐foam pad for soft bulbar urethral support. The pad is attached to silicone columns that, after being passed with needles from the perineum to the abdominal wall, are adjusted with silicone washers to maintain the desired position.
•
Between prostatic surgery and Argus sling placement, most patients (74.3%) had undergone various procedures for SUI or bladder neck pathologies: 22 had undergone secondary irradiation therapy after surgery (19 after retropubic radical prostatectomy [RP], one after perineal RP and two after transurethral resection of the prostate).
•
All patients were evaluated before and after sling placement with 20‐min pad tests, the Urinary Incontinence Quality of Life Scale (I‐QoL), cystoscopy and uroflowmetry. The study was designed in a retrospective longitudinal fashion.
RESULTS
•
The mean (range) follow‐up was 2.1 (0.1–4.5) years. The mean (range) sling surgery duration was 49 (28–105) min.
•
Adjustment was necessary in 39 cases (38.6%), either loosening (10/101; 9.9%) or tightening (29/101; 28.7%) at a mean of 104.3 (14–910) days after the initial implantation.
•
The sling had to be removed in 16/101 patients (15.8%) at a mean of 371.1 (20–1260) days after implantation due to urethral erosion or infection. However, six of the 16 patients were within the first 22 placements and probably represent the ‘learning curve’. In all, 13 of these patients received later successful treatment (seven with an artificial urinary sphincter, five with re‐implantation of the sling). Four of these patients were lost for follow‐up.
•
After a median (mean) follow‐up of 2.2 (2.1) years, 80/101 (79.2%) patients were considered as dry, with a pad test of 0–1 g (70 patients, 0 g; 10 patients, 1 g). The I‐QoL score improved from a mean of 28.8 (14.5–61.8) to 63.2 (16.4–115) points after sling placement.
•
Both the 20‐min pad‐weight tests and I‐QoL responses improved significantly compared with baseline (P < 0.001).
CONCLUSION
•
We think that the Argus male bulbourethral sling system is an excellent first‐ or second‐line treatment for moderate‐to‐severe male SUI, even after external beam radiation treatment. |
---|---|
AbstractList | Study Type – Therapy (case series)
Level of Evidence 4
What’s known on the subject? and What does the study add?
First data on the ARGUS® sling was published in 2006 by Romano SV et al. as a multicentre study, evaluating the data of 48 patients with a mean follow up (FU) of 7.5 months, with the conclusion that this new adjustable sling was effective in treatment of SUI and the complication rate was acceptable. In 2009, Romano SV et al. published a long‐term FU (mean: 45 months) of the same patient group, demonstrating the long‐term efficacy of the sling.
Our study evaluated the data of 101 cases of moderate to severe male stress urinary incontinence (SUI) after implantation of the ARGUS® sling at mean follow‐up of 2.1 (0.1–4.5) years. In addition we made a subgroup analysis of representative “index patients”, patients after external beam radiation therapy (EBRT) and of a subgroup after differentiation of the retrograde leak point pressure (RLPP).
OBJECTIVES
•
To report our experience using an adjustable bulbourethral sling since April 2005 for male stress urinary incontinence (SUI) after prostatic surgery.
•
To evaluate the safety, efficacy and health‐related quality of life in recipients of the Argus® (Promedon SA; Cordoba, Argentina) adjustable bulbourethral sling.
PATIENTS AND METHODS
•
Between April 2005 and April 2009, 101 men with moderate‐to‐severe SUI after prostatic surgery were implanted with the Argus sling.
•
The radio‐opaque Argus system comprises a thick silicone‐foam pad for soft bulbar urethral support. The pad is attached to silicone columns that, after being passed with needles from the perineum to the abdominal wall, are adjusted with silicone washers to maintain the desired position.
•
Between prostatic surgery and Argus sling placement, most patients (74.3%) had undergone various procedures for SUI or bladder neck pathologies: 22 had undergone secondary irradiation therapy after surgery (19 after retropubic radical prostatectomy [RP], one after perineal RP and two after transurethral resection of the prostate).
•
All patients were evaluated before and after sling placement with 20‐min pad tests, the Urinary Incontinence Quality of Life Scale (I‐QoL), cystoscopy and uroflowmetry. The study was designed in a retrospective longitudinal fashion.
RESULTS
•
The mean (range) follow‐up was 2.1 (0.1–4.5) years. The mean (range) sling surgery duration was 49 (28–105) min.
•
Adjustment was necessary in 39 cases (38.6%), either loosening (10/101; 9.9%) or tightening (29/101; 28.7%) at a mean of 104.3 (14–910) days after the initial implantation.
•
The sling had to be removed in 16/101 patients (15.8%) at a mean of 371.1 (20–1260) days after implantation due to urethral erosion or infection. However, six of the 16 patients were within the first 22 placements and probably represent the ‘learning curve’. In all, 13 of these patients received later successful treatment (seven with an artificial urinary sphincter, five with re‐implantation of the sling). Four of these patients were lost for follow‐up.
•
After a median (mean) follow‐up of 2.2 (2.1) years, 80/101 (79.2%) patients were considered as dry, with a pad test of 0–1 g (70 patients, 0 g; 10 patients, 1 g). The I‐QoL score improved from a mean of 28.8 (14.5–61.8) to 63.2 (16.4–115) points after sling placement.
•
Both the 20‐min pad‐weight tests and I‐QoL responses improved significantly compared with baseline (P < 0.001).
CONCLUSION
•
We think that the Argus male bulbourethral sling system is an excellent first‐ or second‐line treatment for moderate‐to‐severe male SUI, even after external beam radiation treatment. • To report our experience using an adjustable bulbourethral sling since April 2005 for male stress urinary incontinence (SUI) after prostatic surgery. • To evaluate the safety, efficacy and health-related quality of life in recipients of the Argus® (Promedon SA; Cordoba, Argentina) adjustable bulbourethral sling. • Between April 2005 and April 2009, 101 men with moderate-to-severe SUI after prostatic surgery were implanted with the Argus sling. • The radio-opaque Argus system comprises a thick silicone-foam pad for soft bulbar urethral support. The pad is attached to silicone columns that, after being passed with needles from the perineum to the abdominal wall, are adjusted with silicone washers to maintain the desired position. • Between prostatic surgery and Argus sling placement, most patients (74.3%) had undergone various procedures for SUI or bladder neck pathologies: 22 had undergone secondary irradiation therapy after surgery (19 after retropubic radical prostatectomy [RP], one after perineal RP and two after transurethral resection of the prostate). • All patients were evaluated before and after sling placement with 20-min pad tests, the Urinary Incontinence Quality of Life Scale (I-QoL), cystoscopy and uroflowmetry. The study was designed in a retrospective longitudinal fashion. • The mean (range) follow-up was 2.1 (0.1-4.5) years. The mean (range) sling surgery duration was 49 (28-105) min. • Adjustment was necessary in 39 cases (38.6%), either loosening (10/101; 9.9%) or tightening (29/101; 28.7%) at a mean of 104.3 (14-910) days after the initial implantation. • The sling had to be removed in 16/101 patients (15.8%) at a mean of 371.1 (20-1260) days after implantation due to urethral erosion or infection. However, six of the 16 patients were within the first 22 placements and probably represent the 'learning curve'. In all, 13 of these patients received later successful treatment (seven with an artificial urinary sphincter, five with re-implantation of the sling). Four of these patients were lost for follow-up. • After a median (mean) follow-up of 2.2 (2.1) years, 80/101 (79.2%) patients were considered as dry, with a pad test of 0-1 g (70 patients, 0 g; 10 patients, 1 g). The I-QoL score improved from a mean of 28.8 (14.5-61.8) to 63.2 (16.4-115) points after sling placement. • Both the 20-min pad-weight tests and I-QoL responses improved significantly compared with baseline (P < 0.001). • We think that the Argus male bulbourethral sling system is an excellent first- or second-line treatment for moderate-to-severe male SUI, even after external beam radiation treatment. Study Type - Therapy (case series) Level of Evidence 4 What's known on the subject? and What does the study add? First data on the ARGUS sling was published in 2006 by Romano SV et al. as a multicentre study, evaluating the data of 48 patients with a mean follow up (FU) of 7.5 months, with the conclusion that this new adjustable sling was effective in treatment of SUI and the complication rate was acceptable. In 2009, Romano SV et al. published a long-term FU (mean: 45 months) of the same patient group, demonstrating the long-term efficacy of the sling. Our study evaluated the data of 101 cases of moderate to severe male stress urinary incontinence(SUI) after implantation of the ARGUS sling at mean follow-up of 2.1 (0.1-4.5) years. In addition we made a subgroup analysis of representative "index patients", patients after external beam radiation therapy (EBRT) and of a subgroup after differentiation of the retrograde leak point pressure (RLPP). OBJECTIVES * To report our experience using an adjustable bulbourethral sling since April 2005 for male stress urinary incontinence (SUI) after prostatic surgery. * To evaluate the safety, efficacy and health-related quality of life in recipients of the Argus (Promedon SA; Cordoba, Argentina) adjustable bulbourethral sling. PATIENTS AND METHODS * Between April 2005 and April 2009, 101 men with moderate-to-severe SUI after prostatic surgery were implanted with the Argus sling. * The radio-opaque Argus system comprises a thick silicone-foam pad for soft bulbar urethral support. The pad is attached to silicone columns that, after being passed with needles from the perineum to the abdominal wall, are adjusted with silicone washers to maintain the desired position. * Between prostatic surgery and Argus sling placement, most patients (74.3%) had undergone various procedures for SUI or bladder neck pathologies: 22 had undergone secondary irradiation therapy after surgery (19 after retropubic radical prostatectomy [RP], one after perineal RP and two after transurethral resection of the prostate). * All patients were evaluated before and after sling placement with 20-min pad tests, the Urinary Incontinence Quality of Life Scale (I-QoL), cystoscopy and uroflowmetry. The study was designed in a retrospective longitudinal fashion. RESULTS * The mean (range) follow-up was 2.1 (0.1-4.5) years. The mean (range) sling surgery duration was 49 (28-105) min. * Adjustment was necessary in 39 cases (38.6%), either loosening (10/101; 9.9%) or tightening (29/101; 28.7%) at a mean of 104.3 (14-910) days after the initial implantation. * The sling had to be removed in 16/101 patients (15.8%) at a mean of 371.1 (20-1260) days after implantation due to urethral erosion or infection. However, six of the 16 patients were within the first 22 placements and probably represent the 'learning curve'. In all, 13 of these patients received later successful treatment (seven with an artificial urinary sphincter, five with re-implantation of the sling). Four of these patients were lost for follow-up. * After a median (mean) follow-up of 2.2 (2.1) years, 80/101 (79.2%) patients were considered as dry, with a pad test of 0-1 g (70 patients, 0 g; 10 patients, 1 g). The I-QoL score improved from a mean of 28.8 (14.5-61.8) to 63.2 (16.4-115) points after sling placement. * Both the 20-min pad-weight tests and I-QoL responses improved significantly compared with baseline (P < 0.001). CONCLUSION * We think that the Argus male bulbourethral sling system is an excellent first- or second-line treatment for moderate-to-severe male SUI, even after external beam radiation treatment. • To report our experience using an adjustable bulbourethral sling since April 2005 for male stress urinary incontinence (SUI) after prostatic surgery. • To evaluate the safety, efficacy and health-related quality of life in recipients of the Argus® (Promedon SA; Cordoba, Argentina) adjustable bulbourethral sling.OBJECTIVES• To report our experience using an adjustable bulbourethral sling since April 2005 for male stress urinary incontinence (SUI) after prostatic surgery. • To evaluate the safety, efficacy and health-related quality of life in recipients of the Argus® (Promedon SA; Cordoba, Argentina) adjustable bulbourethral sling.• Between April 2005 and April 2009, 101 men with moderate-to-severe SUI after prostatic surgery were implanted with the Argus sling. • The radio-opaque Argus system comprises a thick silicone-foam pad for soft bulbar urethral support. The pad is attached to silicone columns that, after being passed with needles from the perineum to the abdominal wall, are adjusted with silicone washers to maintain the desired position. • Between prostatic surgery and Argus sling placement, most patients (74.3%) had undergone various procedures for SUI or bladder neck pathologies: 22 had undergone secondary irradiation therapy after surgery (19 after retropubic radical prostatectomy [RP], one after perineal RP and two after transurethral resection of the prostate). • All patients were evaluated before and after sling placement with 20-min pad tests, the Urinary Incontinence Quality of Life Scale (I-QoL), cystoscopy and uroflowmetry. The study was designed in a retrospective longitudinal fashion.PATIENTS AND METHODS• Between April 2005 and April 2009, 101 men with moderate-to-severe SUI after prostatic surgery were implanted with the Argus sling. • The radio-opaque Argus system comprises a thick silicone-foam pad for soft bulbar urethral support. The pad is attached to silicone columns that, after being passed with needles from the perineum to the abdominal wall, are adjusted with silicone washers to maintain the desired position. • Between prostatic surgery and Argus sling placement, most patients (74.3%) had undergone various procedures for SUI or bladder neck pathologies: 22 had undergone secondary irradiation therapy after surgery (19 after retropubic radical prostatectomy [RP], one after perineal RP and two after transurethral resection of the prostate). • All patients were evaluated before and after sling placement with 20-min pad tests, the Urinary Incontinence Quality of Life Scale (I-QoL), cystoscopy and uroflowmetry. The study was designed in a retrospective longitudinal fashion.• The mean (range) follow-up was 2.1 (0.1-4.5) years. The mean (range) sling surgery duration was 49 (28-105) min. • Adjustment was necessary in 39 cases (38.6%), either loosening (10/101; 9.9%) or tightening (29/101; 28.7%) at a mean of 104.3 (14-910) days after the initial implantation. • The sling had to be removed in 16/101 patients (15.8%) at a mean of 371.1 (20-1260) days after implantation due to urethral erosion or infection. However, six of the 16 patients were within the first 22 placements and probably represent the 'learning curve'. In all, 13 of these patients received later successful treatment (seven with an artificial urinary sphincter, five with re-implantation of the sling). Four of these patients were lost for follow-up. • After a median (mean) follow-up of 2.2 (2.1) years, 80/101 (79.2%) patients were considered as dry, with a pad test of 0-1 g (70 patients, 0 g; 10 patients, 1 g). The I-QoL score improved from a mean of 28.8 (14.5-61.8) to 63.2 (16.4-115) points after sling placement. • Both the 20-min pad-weight tests and I-QoL responses improved significantly compared with baseline (P < 0.001).RESULTS• The mean (range) follow-up was 2.1 (0.1-4.5) years. The mean (range) sling surgery duration was 49 (28-105) min. • Adjustment was necessary in 39 cases (38.6%), either loosening (10/101; 9.9%) or tightening (29/101; 28.7%) at a mean of 104.3 (14-910) days after the initial implantation. • The sling had to be removed in 16/101 patients (15.8%) at a mean of 371.1 (20-1260) days after implantation due to urethral erosion or infection. However, six of the 16 patients were within the first 22 placements and probably represent the 'learning curve'. In all, 13 of these patients received later successful treatment (seven with an artificial urinary sphincter, five with re-implantation of the sling). Four of these patients were lost for follow-up. • After a median (mean) follow-up of 2.2 (2.1) years, 80/101 (79.2%) patients were considered as dry, with a pad test of 0-1 g (70 patients, 0 g; 10 patients, 1 g). The I-QoL score improved from a mean of 28.8 (14.5-61.8) to 63.2 (16.4-115) points after sling placement. • Both the 20-min pad-weight tests and I-QoL responses improved significantly compared with baseline (P < 0.001).• We think that the Argus male bulbourethral sling system is an excellent first- or second-line treatment for moderate-to-severe male SUI, even after external beam radiation treatment.CONCLUSION• We think that the Argus male bulbourethral sling system is an excellent first- or second-line treatment for moderate-to-severe male SUI, even after external beam radiation treatment. |
Author | Gallistl, Helmut Rutkowski, Michael Huber, Erik R. Hübner, Wilhelm A. |
Author_xml | – sequence: 1 givenname: Wilhelm A. surname: Hübner fullname: Hübner, Wilhelm A. – sequence: 2 givenname: Helmut surname: Gallistl fullname: Gallistl, Helmut – sequence: 3 givenname: Michael surname: Rutkowski fullname: Rutkowski, Michael – sequence: 4 givenname: Erik R. surname: Huber fullname: Huber, Erik R. |
BackLink | http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=23908606$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/20964801$$D View this record in MEDLINE/PubMed |
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ContentType | Journal Article |
Copyright | 2010 THE AUTHORS. BJU INTERNATIONAL © 2010 BJU INTERNATIONAL 2015 INIST-CNRS 2010 THE AUTHORS. BJU INTERNATIONAL © 2010 BJU INTERNATIONAL. |
Copyright_xml | – notice: 2010 THE AUTHORS. BJU INTERNATIONAL © 2010 BJU INTERNATIONAL – notice: 2015 INIST-CNRS – notice: 2010 THE AUTHORS. BJU INTERNATIONAL © 2010 BJU INTERNATIONAL. |
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DOI | 10.1111/j.1464-410X.2010.09619.x |
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Keywords | Nephrology Urinary system disease Sling operation stress urinary incontinence Male Urinary tract disease Urology Urinary incontinence Voiding dysfunction Treatment radical prostatectomy Surgery male urinary incontinence Prostatectomy adjustable male sling Bladder disease Severe Urinary stress incontinence |
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References | 2001; 165 1946; 55 1970; 131 1972; 107 2005; 173 2006; 97 1991; 145 2003; 92 1997; 31 1973; 45 1993; 42 2002; 167 1994; 151 1992; 39 2005; 96 2000; 163 1998; 159 1999; 53 2008; 54 2004; 2 2007; 52 2007; 33 2003; 62 1988; 139 e_1_2_7_5_2 e_1_2_7_4_2 e_1_2_7_3_2 e_1_2_7_2_2 e_1_2_7_9_2 e_1_2_7_8_2 e_1_2_7_7_2 e_1_2_7_6_2 e_1_2_7_19_2 e_1_2_7_17_2 e_1_2_7_16_2 e_1_2_7_14_2 e_1_2_7_13_2 e_1_2_7_12_2 e_1_2_7_11_2 e_1_2_7_10_2 e_1_2_7_26_2 e_1_2_7_27_2 Kaufman JJ (e_1_2_7_22_2) 1970; 131 Stamey T (e_1_2_7_18_2) 1994; 151 Marshall V (e_1_2_7_15_2) 1946; 55 e_1_2_7_25_2 e_1_2_7_24_2 e_1_2_7_23_2 e_1_2_7_20_2 Abrams P (e_1_2_7_21_2) 2004; 2 |
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Level of Evidence 4
What’s known on the subject? and What does the study add?
First data on the ARGUS® sling was published... • To report our experience using an adjustable bulbourethral sling since April 2005 for male stress urinary incontinence (SUI) after prostatic surgery. • To... Study Type - Therapy (case series) Level of Evidence 4 What's known on the subject? and What does the study add? First data on the ARGUS sling was published in... |
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SubjectTerms | Abdominal wall adjustable male sling Aged Aged, 80 and over Biological and medical sciences Humans Male male urinary incontinence Medical sciences Middle Aged Needles Nephrology. Urinary tract diseases Perineum Prostate Prostate - surgery Prostate cancer Prostatectomy Prostatectomy - adverse effects Quality of life Radiation radical prostatectomy Silicones Sphincter stress urinary incontinence Suburethral Slings Surgery Treatment Outcome Urinary bladder Urinary incontinence Urinary Incontinence, Stress - surgery Urinary system involvement in other diseases. Miscellaneous Urinary tract. Prostate gland Urologic Surgical Procedures, Male - methods |
Title | Adjustable bulbourethral male sling: experience after 101 cases of moderate‐to‐severe male stress urinary incontinence |
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