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Virtue Quadratic Male Sling

The Virtue quadratic male sling (Coloplast, Humlebaek, Denmark) is a four-arm polypropylene mesh sling combining transobturator and prepubic approaches to treat post-prostatectomy stress urinary incontinence. Its two arm pairs are designed to provide both urethral relocation and urethral compression.[1][2][3][9]

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

Mechanism: incremental RLPP buildup​

The "quadratic" name reflects the four arms: two transobturator and 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) by perfusion sphincterometry in 22 consecutive men after each technical step. Mean RLPP rose at each step:

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

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

Evolution: unfixed vs fixed technique​

The initial Virtue lacked a fixation mechanism and produced disappointing results. In the multinational prospective trials, the fixation cohort had better 12-month outcomes than the initial unfixed cohort:[2]

Cohort12-mo successMedian pad-weight reduction
Unfixed41.9% (subjective and objective)51.1%
Fixation70.9% subjective / 79.2% objective88.3%

Fixation is the current technique. In the fixation cohort, efficacy was similar regardless of baseline incontinence. Objective success was a greater than 50% decrease in 24-hour pad weight, and subjective success was a Patient Global Impression of Improvement score of "much" or "very much" better.[2]

Surgical technique​

  • In lithotomy, place a 14F Foley catheter and make a vertical perineal incision. Preserve the bulbospongiosus muscle and release the central-tendon attachments to mobilize the proximal bulbar urethra approximately 2 cm in the Rubin–Xavier–Rhee technique.[12]
  • Pass each transobturator arm inside-out with the J-hook close to the inferior descending pubic ramus. Palpate the tip approximately 2 cm below and 1 cm lateral to the lower border of the adductor longus tendon, make a stab incision at that exit point, and tension the arms laterally to elevate the bulbar urethra.[12]
  • Make two stab incisions 2 cm above the pubic symphysis and 1–3 fingerbreadths lateral to midline. Pass the J-hook from each skin incision anterior to the pubic bone into the perineal wound, keeping it lateral to the urethral complex; draw the prepubic arms superiorly to compress the bulbar urethra.[12]
  • RLPP tensioning (Rubin–Xavier–Rhee technique). Measure RLPP during sequential tensioning to assess urethral resistance; their guide uses a 60 cm H₂O saline column and tensions the prepubic arms until drip flow stops. This target is technique-specific, not a validated continence guarantee; RLPP was recorded in only 11/117 men in the European multicenter cohort.[1][12][5] In a retrospective comparison of sequential cohorts, cure or improvement at last follow-up (overall median 22 months) occurred in 21/30 (70%) men with RLPP-based tensioning and 7/18 (39%) with cystoscopic tensioning; the median RLPP after fixation in the RLPP cohort was 41 cm H₂O.[17] The 60 cm H₂O saline-column setting used for tensioning did not equal the measured final RLPP in that cohort, and the sequential design cannot exclude a learning effect.[12][17]
  • Fixation step (Rubin, Xavier, and Rhee technique). After sequential arm tensioning, secure the mesh at each body–prepubic-arm junction to pubic periosteum with figure-of-eight sutures; the technical guide describes two sutures per side and rechecking RLPP after clamp release. The fixation cohort reported 70.9% subjective and 79.2% objective success at 12 months, versus 41.9% for both endpoints in the earlier unfixed cohort.[12][2]
  • Before closure. Replace the 14F Foley catheter to confirm it passes the tensioned sling; if it cannot pass, release a fixation suture and replace that suture once the catheter is in place. Cut the prepubic arms at skin level, tunnel the transobturator arm tails subcutaneously back to the perineal incision, and trim them within that incision.[12]

Postoperative care​

In the European cohort, surgeons removed the Foley on postoperative day 1 and discharged patients after a successful voiding trial. The study protocol restricted lifting, squatting and straining for 8 weeks to protect fixation; the Rubin–Xavier–Rhee guide uses 6–8 weeks.[5][12]

Outcomes​

Virtue-specific outcome evidence comes from sequential nonrandomized device trials and observational cohorts; no randomized trial directly compares Virtue with AUS.

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 → 0.9 (12-mo values, stable at 36 mo)Italian prospective, predominantly mild SUI (72.4% used 1–2 pads/day); all 17 complications Clavien I; PGI-I median 1
Roumeguère 2022[5]117 implanted; 59 reached 36 mo (57 with pad-test data)36 mo19% (22/117; 24-hour pad weight <1.3 g)35% objective (41/117; >50% pad-weight reduction) / 34% subjectiveProspective multicenter; intention-to-treat rates count missing outcomes as failures. ICIQ-UI-SF 15 → 9 among assessed men; exploratory BMI/PVR/nocturia/ICIQ model needs external validation; seven Clavien-Dindo grade III events, including four sling revisions; no explantations.
Abramowitz 2021[14]4615.6 mo (median)—78% objective success (≤1 pad/day and no further continence procedure); 85% subjective satisfactionRetrospective single center; outcomes use a different endpoint from Comiter and Roumeguère; 5/46 (11%) underwent transobturator-arm release for penile numbness; 6/46 (13%) underwent sling retensioning for immediate or delayed incontinence, and 1/46 required urethrolysis for retention.
McCall 2016 (Mayo)[6]3155 mo (median)—68% failure (retrospective; failure = no reduction in pad use, explant or AUS); median pads 3 → 222% explanted; 20% required AUS; 7% chronic pain; failure more likely after external beam radiation (p = 0.02). The 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 is divided. Short-to-medium-term prospective data (Ferro, Comiter, Roumeguère) report improvement and acceptable safety. The retrospective Mayo series (McCall 2016) reported a 68% failure rate at 55-month median follow-up, with 22% explantation and 20% subsequent AUS, and the authors abandoned the device.[2][4][5][6]

Reasons for the different cohorts' results are unclear: center experience, fixation technique, patient mix, endpoint definitions and follow-up may contribute.[5][2] A 19% strict cure at 36 months[5] and 79.2% objective success at 12 months with fixation[2] use different definitions and populations. Prior radiation warrants caution because it was associated with failure in the Mayo series, and a meta-analysis of male slings found lower odds of success (OR 0.68) and higher odds of explantation (OR 2.93) after pelvic radiotherapy.[2][5][6][8]

The fixation and European cohorts did not detect a baseline-severity association, but only five men with severe baseline SUI had 36-month pad-test data in the European series. A 2025 meta-analysis across fixed slings found high-certainty evidence that greater pad use and 24-hour urine loss predict failure; these class-wide findings limit reassurance from small Virtue subgroups.[2][5][15] The AUA/GURS/SUFU 2024 guideline advises against routine male sling implantation in severe SUI.[11]

Complications​

Coloplast's April 2024 brief statement contraindicates Virtue implantation with documented polypropylene hypersensitivity, active infection, untreated or serious coagulation disorder, obstructive uropathy, or age <18 years.[9] It also advises evaluation of overactive bladder, postvoid residual, bladder-neck contracture, urethral stricture, and residual sphincteric function before implantation.[9] The same Coloplast brief statement advises weighing additional risks and benefits in patients with autoimmune or connective-tissue disease, coagulation disorders, immunocompromise, diabetes, pelvic radiation, physical characteristics such as BMI, renal insufficiency, or smoking-related conditions.[9] The September 2024 instructions for use (Rev F) list the same contraindications except obstructive uropathy.[16]

  • Implant and voiding risks. Coloplast's December 2020 brief statement lists erosion, infection, adjacent-structure injury, retention, and bladder-outlet obstruction among potential complications.[10] Its April 2024 statement also lists mesh exposure, fistula, and sexual dysfunction, and describes Virtue as permanent; revision may lead to partial or complete removal, which may be impossible or may not resolve symptoms.[9]
  • Explantation was 0% in the European prospective series and 22% in the Mayo series.[5][6]
  • Chronic pain occurred in 2/31 men (7%) in McCall 2016.[6] In a separate 46-man retrospective series, 5/46 (11%) had persistent penile numbness at 3 months; all underwent release of the sutured transobturator arms, with improved sensation in all five but recurrent incontinence in one.[14]
  • In the Roumeguère cohort, 74/117 men experienced at least one adverse event during 36 months (136 events total). Early retention after catheter removal occurred in 9/117 (7.7%); seven of 136 events (5.1%) were grade IIIb, including four sling revisions, one partial sling resection, one botulinum-toxin treatment and one bladder-neck incision/dilation. Grade II overactive-bladder symptoms and pain represented 10.3% and 2.9% of related events, respectively.[5]
  • No prolonged urinary retention or severe AEs in the multinational fixation trial.[2]

Comparison with AUS​

No randomized trial has compared Virtue with AUS. For persistent or recurrent SUI after a male sling, the AUA/GURS/SUFU 2024 guideline recommends AUS ; 6/31 men (20%) in the Mayo Virtue series subsequently received one.[11][13][6]

Current positioning​

Virtue outcomes differ widely between cohorts, and durability is unresolved.[5][6] The European multicenter 19% strict cure at 36 months and the Mayo 68% composite failure at 55-month median follow-up use different definitions.[5][6]

The AUA/GURS/SUFU 2024 amendment recommends discussing male slings for mild-to-moderate SUI, advises against routine sling implantation in severe SUI, and recommends an AUS over a sling or adjustable balloon after radiotherapy . Before SUI surgery, it also calls for cystourethroscopy to assess urethral and bladder pathology .[11] Virtue-specific evidence is limited and conflicting, so patients are counseled that long-term durability is unresolved.

See Also​

Videos​

Virtue Quadratic Male Sling for Stress Incontinence
AUA University (2021)

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

9. Coloplast. Virtue Male Sling four-arm device overview. Manufacturer product page (accessed September 2026).

10. Coloplast. Virtue Male Sling System Brief Statement. Manufacturer safety summary. This summary is not the complete IFU.

11. Sandhu JS, Breyer B, Comiter C, et al. Incontinence after prostate treatment: AUA/SUFU guideline. J Urol. 2019;202(2):369–378. doi:10.1097/JU.0000000000000314. Recommendation statements cited here are from the AUA/GURS/SUFU guideline as amended in 2024.

12. Rubin RS, Xavier KR, Rhee E. "Virtue Quadratic Male Sling for stress incontinence—surgical guide for placement and delayed revision." Transl Androl Urol. 2017;6(4):666-673. doi:10.21037/tau.2017.07.33

13. Breyer BN, Kim SK, Kirkby E, et al. "Updates to incontinence after prostate treatment: AUA/GURS/SUFU guideline (2024)." J Urol. 2024;212(4):531-538. doi:10.1097/JU.0000000000004088

14. Abramowitz D, Sam AP, Pachorek M, Shen J, Ruel N, Warner JN. "Virtue male sling outcomes and application to a contemporary nomogram." Can J Urol. 2021;28(2):10625-10630. PMID:33872562

15. Sacco E, Campetella M, Marino F, et al. "Preoperative risk factors for failure after fixed sling implantation for postprostatectomy stress urinary incontinence (FORESEE): a systematic review and meta-analysis." Eur Urol Open Sci. 2025;77:58-77. doi:10.1016/j.euros.2025.05.012

16. Coloplast A/S. Virtue Male Sling System: Instructions for Use. 70002601 Rev F; September 2024.

17. Sourial MW, Richard PO, Morisset J, Jundi M, Tu LM. "Retrograde leak point pressure measurement improves outcomes of the Virtue male sling for postprostatectomy incontinence." Can Urol Assoc J. 2017;11(7):E271-E276. doi:10.5489/cuaj.4381