Reconstructive Urology The Virtue Sling—A New Quadratic Sling for Postprostatectomy Incontinence—Results of a Multinational Clinical Trial Craig V. Comiter, Eugene Y. Rhee, Le-Mai Tu, Sender Herschorn, and Victor W. Nitti OBJECTIVE
METHODS
RESULTS
CONCLUSION
To successfully perform male sling surgery, and the surgery must achieve proximal urethral relocation and/or bulbar urethral compression. The Virtue quadratic sling is a novel device that incorporates both mechanisms of action. We report the 1-year results of the Virtue sling with fixation and compare it with the results of the initial “unfixed” sling trial. A prospective trial was performed to assess the efficacy and safety of the Virtue sling. Objective success was predefined as >50% decrease in 24-hour pad weight and subjective success as a score of “much” or “very much” better on the Patient Global Impression of Improvement. Subgroups were analyzed by baseline incontinence: mild (400 g). After analysis of the 1-year data, a second clinical trial incorporating a novel “fixation” technique was performed, with similar outcome measures. In the initial cohort, subjective and objective successes were achieved in 41.9% at 12 months. Median pad weight reduction was 51.1% at 12 months and varied with the degree of baseline leakage. In the fixation cohort, subjective and objective successes were 70.9% and 79.2%, median pad weight reduction was 88.3% at 12 months, and efficacy was similar regardless of baseline incontinence. There were no cases of prolonged retention and no severe adverse events. The Virtue sling with fixation is a safe and efficacious treatment for postprostatectomy incontinence. Superior 12-month results compared with the unfixed device demonstrate that fixation prevents early sling loosening. UROLOGY 84: 433e439, 2014. 2014 Elsevier Inc.
I
nnovations in sling design and technique have fostered an increased interest in sling surgery for the treatment of postprostatectomy incontinence (PPI). Surgical principles are similar for all slings: adequate urethral coaptation via elevation and suspension of the proximal urethra, and/or by direct compression of the bulbar urethra is necessary; proper tensioning should prevent leakage during straining, yet allow normal voiding; and suboptimal coaptation will lead to persistent or recurrent leakage. The contemporary male slings have evolved by incremental improvements and innovations. The pubourethral sling1 gave way to the bone-anchored
Financial Disclosure: Craig V. Comiter, Eugene Y. Rhee, and Victor W. Nitti are paid consultants to Coloplast. The other authors declare that they have no relevant financial interests. Funding Support: This work was the result of a clinical trial supported by Coloplast. Each author’s institution received funding for the clinical trial. From the Department of Urology, Stanford University Medical School, Stanford, CA; the Department of Urology, Kaiser Permanente Medical Group, San Diego, CA; the Department of Urology, Universite de Sherbrooke, Quebec, Canada; the Department of Urology, Sunnybrook Health Sciences Center, Toronto, Canada; and the Department of Urology, New York University Langone Medical Center, New York, NY Reprint requests: Craig V. Comiter, M.D., Department of Urology, Stanford University Medical School, 300 Pasteur Drive, Stanford, CA 94305-5118. E-mail: [email protected] Submitted: January 9, 2014, accepted (with revisions): February 28, 2014
ª 2014 Elsevier Inc. All Rights Reserved
sling (InVance) and the retroluminal transobturator (TO) device (AdVance). The former relies on titanium bone screws to secure a 4 7-cm sling, which compresses the perineal portion of the urethra, distal to the bulb.2 The retroluminal sling, on the other hand, provides continence by relocating the proximal urethra noncompressively.3 Each approach substantially improves continence in men with mild-to-moderate PPI. The Virtue (Coloplast, Humlebaek, Denmark) quadratic sling is a hybrid device—a 4-armed large pore knitted monofilament polypropylene mesh—that provides proximal urethral relocation via a TO component and perineal urethral compression via a superior prepubic (PP) component.4 Based on evaluation of initial clinical results, a novel fixation mechanism was incorporated to prevent early sling loosening. We report the 1-year results of the fixated quadratic sling and compare it with those of the unfixed device.
METHODS Two separate prospective multinational clinical trials were performed. The initial trial assessed the efficacy and safety of the Virtue (Fig. 1) for treating stress urinary incontinence (SUI). http://dx.doi.org/10.1016/j.urology.2014.02.062 0090-4295/14/$36.00
433
After completion of this trial, based on analysis of 12-month outcomes, a second trial was performed, which included a novel fixation mechanism, aimed at preventing loss of sling efficacy. For the initial trial, 98 men with at least 6 months of SUI after prostatectomy were enrolled. Subjects were evaluated with urodynamics according to International Continence Society recommended technique (assess storage and voiding function) and cystoscopy (exclude stricture). Brachytherapy, cryosurgery, and external beam radiotherapy were not exclusion criteria unless they occurred within the previous 6 months. Patients were excluded if they did not demonstrate SUI during clinical and urodynamic evaluation, had active stricture disease, detrusor areflexia, or postvoid residual urine (PVR) >150 cc. Primary endpoints included 24-hour pad weight and the Patient Global Impression of Improvement (PGI-I). Subjective success was predefined as “very much better” or “much better” at 12 months. Objective outcomes were based on prior publications defining success as a 50% reduction in pad use5,6 and the high correlation between pad use and pad weight.7 Based on a Food and Drug Administration Guidance document, objective results were classified as cured (
METHODS
RESULTS
CONCLUSION
To successfully perform male sling surgery, and the surgery must achieve proximal urethral relocation and/or bulbar urethral compression. The Virtue quadratic sling is a novel device that incorporates both mechanisms of action. We report the 1-year results of the Virtue sling with fixation and compare it with the results of the initial “unfixed” sling trial. A prospective trial was performed to assess the efficacy and safety of the Virtue sling. Objective success was predefined as >50% decrease in 24-hour pad weight and subjective success as a score of “much” or “very much” better on the Patient Global Impression of Improvement. Subgroups were analyzed by baseline incontinence: mild (400 g). After analysis of the 1-year data, a second clinical trial incorporating a novel “fixation” technique was performed, with similar outcome measures. In the initial cohort, subjective and objective successes were achieved in 41.9% at 12 months. Median pad weight reduction was 51.1% at 12 months and varied with the degree of baseline leakage. In the fixation cohort, subjective and objective successes were 70.9% and 79.2%, median pad weight reduction was 88.3% at 12 months, and efficacy was similar regardless of baseline incontinence. There were no cases of prolonged retention and no severe adverse events. The Virtue sling with fixation is a safe and efficacious treatment for postprostatectomy incontinence. Superior 12-month results compared with the unfixed device demonstrate that fixation prevents early sling loosening. UROLOGY 84: 433e439, 2014. 2014 Elsevier Inc.
I
nnovations in sling design and technique have fostered an increased interest in sling surgery for the treatment of postprostatectomy incontinence (PPI). Surgical principles are similar for all slings: adequate urethral coaptation via elevation and suspension of the proximal urethra, and/or by direct compression of the bulbar urethra is necessary; proper tensioning should prevent leakage during straining, yet allow normal voiding; and suboptimal coaptation will lead to persistent or recurrent leakage. The contemporary male slings have evolved by incremental improvements and innovations. The pubourethral sling1 gave way to the bone-anchored
Financial Disclosure: Craig V. Comiter, Eugene Y. Rhee, and Victor W. Nitti are paid consultants to Coloplast. The other authors declare that they have no relevant financial interests. Funding Support: This work was the result of a clinical trial supported by Coloplast. Each author’s institution received funding for the clinical trial. From the Department of Urology, Stanford University Medical School, Stanford, CA; the Department of Urology, Kaiser Permanente Medical Group, San Diego, CA; the Department of Urology, Universite de Sherbrooke, Quebec, Canada; the Department of Urology, Sunnybrook Health Sciences Center, Toronto, Canada; and the Department of Urology, New York University Langone Medical Center, New York, NY Reprint requests: Craig V. Comiter, M.D., Department of Urology, Stanford University Medical School, 300 Pasteur Drive, Stanford, CA 94305-5118. E-mail: [email protected] Submitted: January 9, 2014, accepted (with revisions): February 28, 2014
ª 2014 Elsevier Inc. All Rights Reserved
sling (InVance) and the retroluminal transobturator (TO) device (AdVance). The former relies on titanium bone screws to secure a 4 7-cm sling, which compresses the perineal portion of the urethra, distal to the bulb.2 The retroluminal sling, on the other hand, provides continence by relocating the proximal urethra noncompressively.3 Each approach substantially improves continence in men with mild-to-moderate PPI. The Virtue (Coloplast, Humlebaek, Denmark) quadratic sling is a hybrid device—a 4-armed large pore knitted monofilament polypropylene mesh—that provides proximal urethral relocation via a TO component and perineal urethral compression via a superior prepubic (PP) component.4 Based on evaluation of initial clinical results, a novel fixation mechanism was incorporated to prevent early sling loosening. We report the 1-year results of the fixated quadratic sling and compare it with those of the unfixed device.
METHODS Two separate prospective multinational clinical trials were performed. The initial trial assessed the efficacy and safety of the Virtue (Fig. 1) for treating stress urinary incontinence (SUI). http://dx.doi.org/10.1016/j.urology.2014.02.062 0090-4295/14/$36.00
433
After completion of this trial, based on analysis of 12-month outcomes, a second trial was performed, which included a novel fixation mechanism, aimed at preventing loss of sling efficacy. For the initial trial, 98 men with at least 6 months of SUI after prostatectomy were enrolled. Subjects were evaluated with urodynamics according to International Continence Society recommended technique (assess storage and voiding function) and cystoscopy (exclude stricture). Brachytherapy, cryosurgery, and external beam radiotherapy were not exclusion criteria unless they occurred within the previous 6 months. Patients were excluded if they did not demonstrate SUI during clinical and urodynamic evaluation, had active stricture disease, detrusor areflexia, or postvoid residual urine (PVR) >150 cc. Primary endpoints included 24-hour pad weight and the Patient Global Impression of Improvement (PGI-I). Subjective success was predefined as “very much better” or “much better” at 12 months. Objective outcomes were based on prior publications defining success as a 50% reduction in pad use5,6 and the high correlation between pad use and pad weight.7 Based on a Food and Drug Administration Guidance document, objective results were classified as cured (
