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 inBJU international Vol. 107; no. 5; pp. 777 - 782
Main Authors Hübner, Wilhelm A., Gallistl, Helmut, Rutkowski, Michael, Huber, Erik R.
Format Journal Article
LanguageEnglish
Published Oxford, UK Blackwell Publishing Ltd 01.03.2011
Wiley-Blackwell
Wiley Subscription Services, Inc
Subjects
Online AccessGet full text
ISSN1464-4096
1464-410X
1464-410X
DOI10.1111/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
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  givenname: Michael
  surname: Rutkowski
  fullname: Rutkowski, Michael
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  givenname: Erik R.
  surname: Huber
  fullname: Huber, Erik R.
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10.1111/j.1464-410X.1973.tb12235.x
10.1097/00005392-200101000-00018
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Issue 5
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
Language English
License CC BY 4.0
2010 THE AUTHORS. BJU INTERNATIONAL © 2010 BJU INTERNATIONAL.
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1992; 39
2005; 96
2000; 163
1998; 159
1999; 53
2008; 54
2004; 2
2007; 52
2007; 33
2003; 62
1988; 139
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Snippet 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...
• 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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StartPage 777
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
URI https://onlinelibrary.wiley.com/doi/abs/10.1111%2Fj.1464-410X.2010.09619.x
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