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Virtue Quadratic Male Sling

The Virtue quadratic male sling (Coloplast, Humlebaek, Denmark) is a four-arm polypropylene mesh sling that uniquely combines transobturator and prepubic approaches to treat post-prostatectomy stress urinary incontinence. It is the only commercially available male sling designed to incorporate both urethral relocation and urethral compression in a single device.[1][2][3]

For positioning vs other male slings, see Male Urethral Slings — chooser.

Mechanism — incremental RLPP buildup​

The "quadratic" name reflects the four arms: two transobturator + two prepubic.[1][2]

  • Transobturator arms → ventral urethral elevation (analogous to AdVance repositioning).
  • Prepubic arms → urethral compression against the genitourinary diaphragm — without bone screws or retropubic needle passage.[1]

Comiter 2012 measured retrograde leak point pressure (RLPP) after each technical step and demonstrated incremental contributions:

StepRLPP (cm H₂O)
Baseline33.4
After transobturator tensioning43.3
After prepubic tensioning55.8
After final fixation68.8

Each step was significantly higher than the preceding one.[1]

Evolution: unfixed vs fixed technique​

The initial Virtue lacked a fixation mechanism and produced disappointing results. The multinational trial comparing unfixed vs fixation showed dramatic improvement with fixation:[2]

Cohort12-mo subjective + objective successPad-weight reduction
Unfixed41.9%51.1%
Fixation70.9% subjective / 79.2% objective88.3%

Fixation is now the standard technique. Efficacy was similar regardless of baseline severity in the fixation cohort.[2]

Surgical technique​

  • Lithotomy; perineal incision over the bulbar urethra.
  • Two transobturator arms through the obturator foramen → urethral elevation.
  • Two prepubic arms anterior to the pubic bone → urethral compression.
  • Intraoperative RLPP measurement confirms adequate urethral resistance.
  • Fixation step is critical — the original unfixed design produced 41.9% success vs 79.2% with fixation.[1][2]

Outcomes​

The evidence base is observational with no RCTs. Results vary substantially across centers — the central feature of the Virtue literature is its divergence between European short-term success and Mayo long-term failure.

StudyNFollow-upCureImprovementNote
Comiter 2014 (fixation)[2]—12 mo—70.9% subj / 79.2% obj88.3% pad-weight reduction; efficacy across all severity strata
Ferro 2017[4]2936 mo—Pad weight 128.6 → 2.5 g; pads/day 2 → 0; ICIQ-SF 14.3 → 0.9Italian prospective, predominantly mild SUI; all 17 complications Clavien I; PGI-I median 1
Roumeguère 2022[5]11736 mo19%51% objective / 34% subjectiveEuropean multicenter; ICIQ-UI-SF 15 → 9; BMI, PVR, nocturia, ICIQ predict outcome; 5.1% Clavien IIIb
McCall 2016 (Mayo)[6]3155 mo (median)—68% failure; pads 3 → 2 only22% explanted; 20% required AUS; 7% chronic pain; radiation predicted failure (p = 0.02). Authors abandoned the device.
Hogewoning 2017[7]812 mo4 / 8 continent2 / 8 improvedSmall post-TURP series; very limited evidence for that indication

The long-term controversy​

The Virtue evidence base is sharply divided. Short-to-medium-term European data (Ferro / Comiter / Roumeguère) show meaningful improvement and acceptable safety; the Mayo Clinic long-term experience (McCall 2016) reported a 68% failure rate at 55-month median follow-up with 22% explantation and 20% subsequent AUS requirement, leading the authors to abandon the device.[6]

Reasons for the divergence are unclear — center experience, fixation technique, patient mix, and follow-up duration likely all contribute. The wide variability in reported outcomes (19% strict cure to 79% objective success) makes firm recommendations difficult, and prior radiation should be considered a relative contraindication based on the Mayo data and the broader male-sling literature.[6][8]

Unlike the AdVance, baseline severity has not consistently predicted outcome — fixation-cohort efficacy was similar across mild, moderate, and severe SUI.[2][5]

Complications​

  • No urethral erosion has been reported across Virtue-specific studies.
  • Explantation rates 0% (multinational fixation trial) to 22% (Mayo long-term).[2][6]
  • Chronic pain ~ 7% in McCall 2016.[6]
  • 5.1% Clavien IIIb in Roumeguère 2022 (sling revisions); most frequent grade II were OAB symptoms (10.3%) and pain (2.9%).[5]
  • No prolonged urinary retention or severe AEs in the multinational fixation trial.[2]

Comparison with AUS​

Not directly compared in any RCT. In the Mayo series, 20% of Virtue patients ultimately required AUS placement.[6]

Current positioning​

The Virtue occupies a controversial position in the male SUI armamentarium. The dual mechanism is theoretically attractive, but the conflicting long-term data raise reproducibility and durability concerns. The European multicenter 19% strict cure at 36 months and the Mayo 68% failure at 55 months are difficult to reconcile.[5][6]

The device may be considered for post-prostatectomy SUI across severity levels — particularly for patients who are not candidates for AUS — but the evidence base is limited and conflicting. Prior radiation should be a relative contraindication. Patients should be counseled that the long-term durability question is unresolved.

See Also​

References​

1. Comiter CV, Nitti V, Elliot C, Rhee E. A new quadratic sling for male stress incontinence: retrograde leak point pressure as a measure of urethral resistance. J Urol. 2012;187(2):563–568. doi:10.1016/j.juro.2011.09.152

2. Comiter CV, Rhee EY, Tu LM, Herschorn S, Nitti VW. The Virtue sling — a new quadratic sling for postprostatectomy incontinence — results of a multinational clinical trial. Urology. 2014;84(2):433–438. doi:10.1016/j.urology.2014.02.062

3. Comiter C. Surgery for postprostatectomy incontinence: which procedure for which patient? Nat Rev Urol. 2015;12(2):91–99. doi:10.1038/nrurol.2014.346

4. Ferro M, Bottero D, D'Elia C, et al. Virtue male sling for post-prostatectomy stress incontinence: a prospective evaluation and mid-term outcomes. BJU Int. 2017;119(3):482–488. doi:10.1111/bju.13672

5. Roumeguère T, Elzevier H, Wagner L, et al. The Virtue quadratic male sling for postradical prostatectomy urinary incontinence: 3-year outcome measurements and a predictive model of surgical outcome from a European prospective observational study. Neurourol Urodyn. 2022;41(1):456–467. doi:10.1002/nau.24851

6. McCall AN, Rivera ME, Elliott DS. Long-term follow-up of the Virtue quadratic male sling. Urology. 2016;93:213–216. doi:10.1016/j.urology.2016.03.012

7. Hogewoning CRC, Meij LAM, Pelger RCM, et al. Sling surgery for the treatment of urinary incontinence after transurethral resection of the prostate: new data on the Virtue male sling and an evaluation of literature. Urology. 2017;100:187–192. doi:10.1016/j.urology.2016.08.060

8. Ghaffar U, Abbasi B, Fuentes JLG, et al. Urethral slings for irradiated patients with male stress urinary incontinence: a meta-analysis. Urology. 2023;180:262–269. doi:10.1016/j.urology.2023.07.022