Reconstructive UrologyThe Virtue Sling—A New Quadratic Sling for Postprostatectomy Incontinence—Results of a Multinational Clinical Trial
Section snippets
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). 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
Results
Baseline characteristics are listed in Table 1. There were no differences in baseline pad use, pad weight, or other characteristics.
Comment
Approximately, 217,000 men are diagnosed with prostate cancer in the U.S. each year, with 50% ultimately choosing surgery as their treatment of choice.9 And, although the incidence of PPI varies with the definition of incontinence and the method of evaluation, an estimated 4% of prostatectomy patients will opt for surgical management to treat their incontinence within the first 3 years after their cancer surgery.10
Until the late 1990s, the most common surgical treatments for PPI were collagen
Conclusion
The Virtue sling with fixation is a safe and efficacious treatment for PPI, with substantial improvements in subjective and objective measures of continence at 1 year postoperatively. Based on suboptimal maintenance of continence with the unfixed device, the addition of a straightforward fixation technique mediated a substantial improvement in sling efficacy. The stable results over 1 year support the concept that fixation prevents early sling loosening, without adversely affecting bladder
References (26)
- et al.
Long-term results of the bulbourethral sling procedure
J Urol
(2005) - et al.
A new quadratic sling for male stress incontinence: retrograde leak point pressure as a measure of urethral resistance
J Urol
(2012) - et al.
Treatment of postprostatectomy male urinary incontinence with the transobturator retroluminal repositioning sling suspension: 3-year follow-up
Eur Urol
(2012) - et al.
How well patient perception of pad use correlates with the degree of incontinence in post prostatectomy incontinence: the SUFU pad test study
J Urol
(2013) - et al.
AdVance/AdVance XP transobturator male slings: preoperative degree of incontinence as predictor of surgical outcome
Urology
(2013) - et al.
Population based study of long-term rates of surgery for urinary incontinence after radical prostatectomy for prostate cancer
J Urol
(2012) - et al.
13 years of experience with artificial urinary sphincter implantation at Baylor College of Medicine
J Urol
(2007) - et al.
Long-term durability and functional outcomes among patients with artificial urinary sphincters: a 10-year retrospective review from the University of Michigan
J Urol
(2008) - et al.
Artificial urinary sphincter versus male sling for post-prostatectomy incontinence—what do patients choose?
J Urol
(2009) - et al.
The bone anchor suburethral synthetic sling for iatrogenic male incontinence: critical evaluation at a mean 3-year followup
J Urol
(2009)
The AdVance male sling: anatomic features in relation to mode of action
Eur Urol Supp
Efficacy of artificial urinary sphincter implantation after failed bone-anchored male sling for postprostatectomy incontinence
Urology
Absorbable versus nonabsorbable graft: outcome of bone anchored male sling for post-radical prostatectomy incontinence
J Urol
Cited by (51)
Male Slings for Postprostatectomy Incontinence: A Systematic Review and Meta-analysis
2020, European Urology FocusCitation Excerpt :The subjective cure rate is higher than the objective cure rate in all studies where both were reported, which was the case in 34.7% (25/72) of the cohorts. Although the objective cure rate is only moderate in some studies [14,31,44], patients still seemed satisfied with the procedures. Even though the AUS is still the standard of care in the treatment of severe incontinence and its subjective cure rate is up to 80% [74], patients prefer a male sling to AUS as they wish to avoid a mechanical device [75].
Efficacy of the VIRTUE male quadratic sling in the treatment of stress urinary incontinence: A retrospective study
2019, Progres en UrologieCitation Excerpt :Similarly, we have well noticed in our study that patient with milder incontinence have better post-operative results. In addition, we fixed the retropubic arms over the pubic rami and this maneuver is well demonstrated to be associated with much better objective reduction in pad weight in comparison to non-fix (79% vs. 41.9%) [6]. Sourial et al. tried to adjust the retropubic arms pressure by carrying out a RLPP at 60 cm H2O and they confirm better outcome in compare to cystoscopic verification (70% vs. 39%) [8].
Titanized Transobturator Sling Placement for Male Stress Urinary Incontinence Using an Inside-out Single-incision Technique: Minimum 12-Months Follow-up Study
2018, UrologyCitation Excerpt :Eight patients (18.2%) reported postoperative perineal numbness that resolved spontaneously at last follow-up, except for a patient who reported persistent glandular hypoesthesia. In the present study on TiLOOP Male sling, we observed satisfactory functional outcomes at an intermediate-term follow-up, consistent with those reported with other RTS,3,5,17-20 although differences in patient population, surgical techniques, surgeon's experience, outcomes assessment, and definitions make it difficult to compare studies quantitatively. Subjective results were also favorable and in line with other previous studies on RTS.12,17,19,21
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.