Fig. 1
Virtue™ male sling. The four arms are covered with polyethylene sleeves. Extending from the ends of each arm are braided polyester sutures, which allow for attachment to the introducer and facilitate positioning of the sling in situ
Perineal Dissection
The patient is sterilely prepared and draped and positioned in dorsal lithotomy, with the anus covered and isolated from the surgical field. A 14F catheter is placed to help identify the urethra, and a 5 cm vertical midline perineal incision is centered over the bulbous urethra. The urethra and descending pubic rami are exposed bilaterally, while leaving the bulbospongiosus muscle intact. Using sharp dissection, the bulbous urethra is partially detached from the central tendon to the perineal body, thereby allowing ventral urethral elevation (Fig. 2).
Fig. 2
Dissection of the bulbous urethra off the central tendon of the perineum
Transobturator Semilunar Trocar Passage
The Virtue™ male sling comes packaged with a single, bidirectional, semilunar trocar that is used to pass both the transobturator and prepubic arms of the quadratic sling. The suture of the posterior arm of the sling must be looped onto the end of the semilunar trocar. For the TO arms of the sling, the trocars are passed in an in-to-out fashion, from the perineal incision out through groin stab incisions. The semilunar trocar is then passed using the surgeon’s dominant hand from the perineal wound, at the 10 and 2 o’clock position behind on the patient’s right and left inferior pubic rami respectively. The trocar tip should exit from the groin approximately 2–3 cm inferior to the insertion of the adductor longus tendon. Skin overlying the trocar tip is incised and the tip of the trocar and attached suture are exposed. The arm of the sling is pulled out through the groin incision.
Prepubic Semilunar Trocar Passage
The semilunar trocar for the PP arms of the Virtue® sling is passed in an out-to-in fashion. Pubic skin incisions are made 2–3 fingerbreadths from lateral to midline overlying the pubic symphysis. Local anesthetic is infiltrated. The semilunar trocar is then passed using the surgeon’s dominant hand from the pubic incision, anterior to the pubic bone and lateral to the spermatic cord, out through the perineal incision. Perineal incision may be retracted cephalad using a retractor assist with trocar passage. The suture loops from the prepubic arms are then attached to the ends of the semilunar trocar, and the PP extensions of the sling are passed out through the pubic incision.
Sling Tensioning
Sling arms are then progressively and symmetrically tensioned such that the transobturator arms elevate the bulbar urethra by 2–3 cm, and the prepubic arms provide compression of the bulbar and membranous urethra. Concurrent with sling tensioning, a retrograde leak point pressure is obtained by inserting a small catheter into the fossa naviculars and then connecting this to a bladder irrigation tubing with a drip chamber set at a water height of 60 cm above the pubic symphysis. Once ready to tension, the irrigation tubing is then opened and progressive sling tension is applied to the transobturator arms until the drip chamber flow starts to slow. Slow progressive tension is then applied to the prepubic arms until the drip chamber flow completely stops, indicating that a retrograde leak point pressure of 60 cm water has been achieved (Fig. 3).
Fig. 3
Measurement of retrograde leak point pressure
Sling Arm Fixation
Once the appropriate retrograde leak point pressure has been achieved, full tension is placed along the prepubic arms, and then the distal aspect of the sling adjacent to the prepubic arms is secured to the underlying periosteum of the inferior pubic rami using a 2-0 Prolene permanent monofilament suture (Fig. 4). The TO arms are then tunneled subcutaneously back through the perineal incision using a hemostat. Tension is placed along the transobturator arms, retrograde leak pressure of 60 cm water is confirmed, and then the overlapping transobturator arms are fixed to each other in midline using 2-0 Prolene and excess sling arms transected (Fig. 5). Likewise, for the prepubic arms, once properly fixated, the plastic sleeves of the prepubic arms are removed and the arms trimmed at skin level. Incisions are then irrigated and closed in multiple layers. If the surgeon believes there is insufficient tension to achieve adequate continence (RLPP <60 cm water), then the central portion of the sling may be plicated using permanent monofilament suture to provide additional compressive effect.
Fig. 4
The suprapubic arms are tensioned and secured to the periosteum of the pubic bone (arrow indicates site of suture placement)
Fig. 5
Fixation of the prepubic arms and the transobturator arms maintains tension and efficacy
Postoperative Care
All wounds should be copiously irrigated with antibiotic solution. The stab wounds are then closed, and the perineal wound is closed in multiple layers. A 14 F catheter should be left in for 2 days, followed by a trial of voiding. Patients are advised to avoid lifting objects heavier than 10 pounds for at least 6 weeks following surgery. They should also refrain from strenuous activity that might place excess stress on the perineum, including the avoidance of running, squatting, bicycle riding and sexual activity.
Complications
Intraoperative Complications
Urethral Injury
Urethral injury recognized at the time of male sling placement is an absolute contraindication to implantation of synthetic polypropylene mesh adjacent to the genitourinary system. Due to the risk of contaminating the implant material with urine extravasation from a lower urinary tract injury, any inadvertent entry into the urethra precludes placement of implantation of permanent synthetic material. When concern for entry into the urethra exists, indigo carmine may be instilled into the urethra while occluding the urethral meatus. [40] Alternatively, flexible cystoscopy may be performed. In the event of urethral injury, sling placement should be aborted, the wound irrigated, and then the urethrotomy closed and a catheter replaced for 2 weeks. Repeat attempt at sling placement may be considered 3 months later. There have been no reports of urethral injury with the quadratic sling. By leaving the bulbospongiosus muscle intact, the risk of iatrogenic urethrotomy should be minimized.
Postoperative Complications
Urinary Retention
Chronic urinary retention following sling placement is fortunately an uncommon complication when patients are appropriately evaluated preoperatively for the strength of detrusor contraction and selected for the appropriate anti-incontinence procedure. Rates for postoperative urinary retention following transobturator sling have been reported to range from 3 to 23% [27] compared to 0% for the quadratic sling [41]. It should be noted, however, that all patients included in the Virtue sling clinical trials had urodynamically proven normal bladder contractility.
Mesh Erosion
Mesh exposure rates for various male slings are acceptably low at less than 1% and have not been reported to date with the quadratic sling. All delayed mesh exposures require excision from the urinary tract and repair of the involved lower urinary tract structure. In the setting of infection, following excision of the infected mesh and catheter placement, formal urethroplasty should be delayed until stabilization of the involved urethra has been demonstrated.
Recurrent Incontinence
Recurrent incontinence following male sling placement should be thoroughly evaluated with a careful history, physical exam and urodynamics. Cystoscopy should be considered in any patient with physical exam findings concerning for device erosion. Video urodynamics are essential to distinguish among detrusor overactivity, diminished vesical compliance, and recurrent or persistent intrinsic sphincter deficiency. While revision of the quadratic sling via midline plication has been reported, comparison of repeat/revision quadratic sling surgery and placement of an artificial urinary sphincter has not been reported. However, repeat transobturator sling placement has been shown to have a substantially lower success rate than does AUS placement as a salvage procedure [42], and it is the author’s opinion that artificial urinary sphincter placement is the procedure of choice in the patient with a failed quadratic sling. Following quadratic sling placement, the sling is easily identified overlying the bulbar urethra, incised in midline, and dissected free from the underlying bulbar urethra at the time of sphincter placement (Fig. 6). Previous preservation of the bulbospongiosus muscle simplifies the subsequent urethral dissection, making AUS placement a straightforward procedure.
Fig. 6
(a) The quadratic sling is easily identified and dissected off the urethra. (b) Sling is incised, exposing the bulbospongiosus, for straightforward artificial sphincter placement
Virtue™ Results
By combining the mechanisms of action of the bone anchored perineal and the transobturator retroluminal slings, the quadratic device can increase urethral resistance more than a purely perineal or TO approach. The original cadaveric study of the predecessor ventral urethral elevation plus (VUE+) Sling demonstrated this additive effect [43], which was confirmed in a cohort of 22 men with PPI undergoing Virtue sling placement. A sequential and additive increase in urethral resistance (measured by retrograde leak point pressure) followed tightening of the TO and then the PP extensions [44].
Virtue™ Sling Without Fixation
In the initial report of the Virtue™ quadratic sling, 98 men with postprostatectomy incontinence (mean age 67.0 years) underwent Virtue sling implantation without sling fixation [40]. Objective success (defined as >50% improvement in pad weight) was realized in 61.3% at 6 weeks but progressively declined to 55.1%, 53.8%, and 41.9% at 3, 6, and 12 months, respectively. Median pad weight improved for the entire cohort from 203.0 g (IQR 82.6, 541.1) at baseline to 65.0 g (IQR14.9, 304.4) at 6 weeks but increased to 99.2 g (IQR 25.0, 300.0) by 12 months. Median percent reduction in pad weight for the cohort was 68.0% at 6 weeks, but only 51.1% at 12 months. Cure (<1.3 g/day) was realized in 20% at 6 weeks, declining to 15% at 12 months.
Subjective, success (defined as PGI-I very much/much improved) was achieved in 56.4% at 6 weeks, declining to 41.9% at 12 months. All complications were Clavien-Dindo grade 1. The most common non-serious AEs were short-term paresthesias (12.2%), and temporary perineal pain (24.3%). There were no sling infections or erosions, and no change in mean post void residual volume.
Virtue™ Sling with Fixation
The importance of proper sling fixation was demonstrated in a separate cohort of 31 men (mean age of 66.2 years) [41]. The Virtue sling was implanted in a similar fashion to the prior cohort, but with the novel fixation method described previously: with the TO arms fixed in the midline and the PP arms fixed to the soft tissue over the pubic symphysis. Preoperatively 43.3% had mild, 23.3% had moderate, and 33.3% had severe incontinence. A 50% improvement in pad weight was realized in 85.2% at 6 weeks and maintained in 79.2% at 12 months (p < 0.01 vs. baseline). Success did not vary with baseline pad weight, with 80% in the mild group, versus 83.3% in the moderate group, and 71.4% in the severe group at 12 months. Cure was achieved in 49% at 6 weeks and was maintained at 46% at 12 months. Median pad weight for the cohort improved from 147.0 g (IQR 43.0, 431.0) at baseline to 12.0 g (IQR 2.0 86.0) at 6 weeks and was maintained at 18.0 g (IQR 4.0, 109.0) at 12 months (p < 0.01 vs baseline). Median percent reduction in pad weight for the cohort was 89.3% at 6 weeks, and 88.3% at 12 months, and did not differ significantly among the subgroups based on baseline pad weight. For those with mild leakage, per cent reduction in pad weight was 89.7% at 12 months versus 89.6% in the moderate group and 72.2% in the severe group (p > 0.05).
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