InVance® Male Sling System

Overview

The InVance Male Sling System is an innovative, safe and effective surgical approach for mild to moderate stress urinary incontinence in men following prostatectomy. It also is a solution for men who are not candidates for an artificial urinary sphincter due to limited manual dexterity, limited mental capacity or patient preference.

InVance uses a mesh sling, anchored with small bone screws for secure fixation, to provide compression of the urethra. With this minimally invasive treatment, most patients are continent immediately following the procedure and can resume normal, non-strenuous activities within a few days.

InVance Components

  • The Inserter — The InVance Male Sling Inserter is a sterile, single-use, battery powered device so there's nothing to autoclave. It drives screws at low speed with uniform torque and comes with an 8cm shaft that locks into the Inserter. An optional shaft sleeve is also included, which helps to prevent tissue from being wrapped around the shaft during screw insertion.
  • The Screws — Titanium bone screws with pre-attached No. 1 polypropylene suture enable secure fixation. The small, self-tapping screws bite quickly, providing strong fixation which can contribute to lasting continence. To date there have been no reported incidences of bone screw infection in InVance procedures. Screws automatically disengage from the shaft upon full insertion.
  • The Sling — InteMesh™ is a silicone-coated polyester mesh from American Medical Systems, Inc. (AMS). Its knit structure helps to ensure high suture pullout forces.

Benefits

The InVance Male Sling System offers many benefits for you and your patients:

  • Straight-forward procedure — Single perineal incision for a minimally invasive surgery. Uncomplicated surgical technique with high success rate and low complications.
  • Requires Only Spinal Anesthesia — For you that means faster patient prep and less operating room time than with general anesthesia.
  • Fast Results — Allows for immediate outcome assessment. No patient activation or manipulation required.

Placement & Function

Three screws are placed on each side of the descending ramus to act as six fixation points for the InVance sling. Each of the screws has sutures attached. The sutures are passed through the sling pores and tied tightly.

The sling provides ventral compression of the urethra, thus eliminating or greatly reducing the possibility of urine leakage.

Procedure

Implantation of the InVance male sling system is a minimally invasive procedure that typically takes around 30-45 minutes. Following is a brief summary of the InVance surgical procedure.

Caution: This information is for educational purposes only. Refer to the surgical step procedure and videos for more detailed instructions on this surgical procedure.

Step 1

Place the patient in a modified lithotomy position. Insert a 14 Fr. Foley catheter into the bladder to aid in urethral palpation. Palpate the symphysis pubis to determine the incision site. Make a 3-4 cm midline perineal incision.

Step 2

Carry out scissor dissection laterally to expose the medial aspect of the descending pubic rami on both sides. Expose the bone where the screws are to be placed. Preserve the bulbospongiosus.

Step 3

Using the InVance Inserter, place three AMS Screws with polypropylene sutures in each rami. Place the proximal pair as high on the descending ramus as possible, just beneath the pubic symphysis. Space the subsequent pairs 1 cm apart.

Step 4

Grasping the InVance Inserter, press the screw firmly to the bone. Activate the Inserter until the motor changes pitch, indicating that the screw is firmly seated. Pull on the suture to ensure good capture.

Step 5

After all screws are placed, cut the ends of each suture. The sling material can be trimmed to ensure appropriate fit on the pubic bone. On one side, pass sutures through the sling material with the aid of an 18 gauge needle. Firmly tie the sling to the bone on that side.

Step 6

Using a right angle clamp, pull the sling across the urethra to approximate its secured position. Confirm tension using either a Cough Test (if patient is awake) or Retrograde Perfusion Pressure (RPP) Test. Mark the sling material with a sterile marker to facilitate suture placement.

Step 7

Cough Test — (Only if patient is awake) Fill the bladder and ask the patient to give a strong cough to determine appropriate sling tension.

RPP Test — Pull back the catheter into the distal penile urethra and fill the balloon with 1cc of saline. Connect the catheter to a saline infusion bag via sterile tubing. Elevate the bag until infusion begins. Record the retrograde leak point pressure in cm of water from the level of the symphysis to the top of the fluid column (top of water level in saline bag).

Step 8

Pass the remaining sutures through the sling material. Tie the sling down completely, beginning with the most anterior screw. Confirm appropriate sling tension and trim all sutures. Close in a multi-layer closure.

Results

High Success Rate

One recent study showed that InVance® improved 92% of patients. 1

Efficacious

UCLA Prostate Cancer Index (PCI) Incontinence Score before and after the InVance implant. 1


1. Ullrich NF, Comiter CV. The male sling for stress urinary incontinence: 24-month followup with questionnaire based assessment. J Urol Jul 2004 v. 172(1) P.207-9.

Patient Selection

The InVance Male Sling system is a treatment option for mild to moderate stress urinary incontinence which results from a radical prostatectomy.

The InVance procedure may be used as a second option after unsuccessful collagen injections. It is also an option for more severely incontinent patients who are not candidates for an artificial urinary sphincter or who do not wish to pursue that prosthetic option.

InVance is contraindicated in patients with:

  • Bone deformation or other pathological conditions of the bone, such as severe osteoporosis, which would impair secure bone screw fixation
  • Compromised immune system
  • Urinary tract infections
  • Previous or active osteomyelitis
  • Renal insufficiency, and upper and/or lower urinary tract relative obstruction

Safety Information