Surgical GuideFor The Virtue Male Sling System

Male Sling System

The material provided in this protocol is intended for general information purposes only and is not intended to provide complete surgical instructions. Please consult the Virtue Male Sling System Instructions For Use to obtain detailed information regarding the implant procedure, contraindications, warnings, precautions and potential complications/adverse events. For further information, call Coloplast Corp. at 800.258.3476 and/or consult the company website at www.coloplast.com.

4Arm

Approachfor elevation and

elongated compression

Alexis® Wound Protector/Retractor

J-hookIntroducer

Virtue Sling

Surgical GuideAdditional Operating Room MaterialsThe following list of instruments represents an example of what may be used during the implantation of the Virtue male sling. This list may vary according to the individual.

Standard perineal surgical instruments (electrocautery, scissors, hemostats, needle holders, etc.)Suction collection bagPreoperative antibioticsFoley catheter (typically 14 Fr)1L normal saline or water bag60cm tape measureAntibacterial irrigationO silk suture x13-0 chromics x 23-0 vicryl undyed x 20-prolene on a CT2 needle x 4Pediatric Dever retractorPain medication

Dermabond®

Patient Position1. Patient should be placed in a dorsal lithotomy position and prepared for perineal surgery according to facilities standard protocol.

Consider: Place a suction collection bag underneath the buttocks.

2. Perform cystoscopy to determine a baseline urethral coaptation and place an appropriate sized Foley catheter (typically 14 Fr).

Surgical Technique3. Make a vertical perineal incision in the midline.

4. Dissect to isolate the ventral bulbous urethra and the pubic rami ensuring the bulbospongiosus muscle is intact.

5. Create a circumferential ridge on the lower internal portion of the incision.

6. Insert the Alexis Wound Protector/Retractor (green ring) into the incision so the inferior portion of the ring rests on the previously created circumferential ridge.

7. Fold the white ring inward on itself until the retractor is snug against the skin.

8. Leaving the bulbospongiosus muscle intact, partially take down the central tendon.

Transobturator Arm PlacementNote: The transobturator arms are implanted using an inside-out technique.

9. Attach the suture loop of the Virtue Sling transobturator arm to either the L or T slot of the J-hook Introducer.

Cystoscopy showing internal sphincter

Dissected bulbous urethra with intact bulbospongious muscle

Deployed Alexis retractor

Central tendon dissected ~2 to 3 cm off the bulbous urethra

10. Pass the J hook introducer via the perineal incision from medial to lateral through the obturator foramen as an inside-out movement starting ~2 cm below the triangular junction of the corpus spongiosum and corpus cavernosa.

11. The angle of the J-hook Introducer should be at the 10 o’clock position on the subject’s right side and the 2 o’clock position on the subjects left side.

Note: The J-hook Introducer should exit the skin ~4 cm below the adductor longus tendon and ~2 cm lateral from the groin crease.

12. Make a small stab incision through the skin at the desired exit location to facilitate J-hook Introducer passage.

13. Detach the suture from the J-hook Introducer, and pull the sling arm through the tissue.

14. Repeat these steps on the patient’s contralateral side.

Prepubic Arm PlacementNote: The prepubic arms are implanted using an outside-in technique.

15. Make a skin stab incision ~2 cm above the pubic symphysis and ~2 cm lateral to the midline.

16. Pass the J-hook Introducer prepubically through the pubic incision and out through the perineal incision lateral to the urethra. The J-hook Introducer is passed anterior to the pubic bone to decrease risk of urethral or bladder perforation and medial to the spermatic cord to avoid injury.

17. Attach the suture loop of the Virtue Sling prepubic arm to the T-slot of the J-hook Introducer and pass through the tissue.

18. Detach the suture from the J-hook Introducer and pull the prepubic arm through the tissue.

19. Repeat these steps on the patient’s contralateral side.

Tensioning and Fixation of ArmsNote: Tension the obturator and prepubic arms progressively and in succession.

20. Place moderate tension on the transobturator arms by simultaneously pulling on both arms to elevate the bulbous urethra

21. Place moderate tension on the prepubic arms by simultaneously pulling both arms cephalad to compress the bulbous urethra.

Attachment of the sling arm suture to the J-hook Introducer T slot.

2 o’clock positioning of the J-hook Introducer for transobturator arm placement on the patient’s left side

Identification of landmarks for transobturator arm passage

J-hook Introducer positioned for prepubic arm placement

Identification of landmarks for prepubic arm passage

22. Apply maximum tension on the transobturator arms followed by maximum tension on the prepubic arms.

Consider: Assess the impact of varying degrees of prepubic arm tension during a Retrograde Leak Point Pressure test to determine the desired level of tension.

23. While holding the desired level of maximum pressure on the prepubic arms, fixatate the mesh to the soft tissue and periostium ~1cm lateral and ~1cm below the symphysis pubis with a prolene (0 or #1) suture.

Consider: Use of a figure of eight stitch with the first pass being deep in the soft tissue and periosteum and the second pass going through the mesh only to assist with suture fixation.

Note: Be careful to avoid the insertion of the adductor longus tendon during placement of the fixation sutures.

24. Repeat these steps on the patient’s contralateral side.

25. Cut the transobturator and prepubic arms below the arm suture and remove the plastic sleeve covers.

26. Tunnel the transobturator arms by passing a clamp from the perineal incision through the subcutaneous tissue to the skin stab incision, grasping the mesh arm and pulling it back into the perineal incision.

26. Trim any excess mesh from the prepubic and transobturator sling arms.

Note: A cystoscopy may be performed to verify there is adequate urethral coaptation and no urethral or bladder injury.

27. Remove the Alexis Wound Protector/Retractor and close the surgical incisions in multiple layers.

Note: Dermabond may be used to close the transobturator and prepubic skin stab incisions.

Subcutaneous tunneling of transobturator arms

Cystoscopy revealing circumferential urethral coaptation

Figure of eight stitch used to fixate prepubic arms

Prepubic arms fixated into the periostium

Cephalad tensioning of the prepubic arms

Coloplast Corp. Urology Care Surgical Support 800.258.3476

www.coloplast.us The Coloplast logo and Virtue are registered trademarks of Coloplast A/S. Alexis is a registered trademark of Applied Medical. Dermabond is a registered trademark of Johnson & Johnson. © 2016. All rights reserved. Coloplast Corp., Minneapolis, MN USA.

PM00098 / M2629N 8.16

Important Risk InformationThe Virtue male sling requires surgery. Risks of surgery may include but are not limited to complications such as infection, swelling, pain and discomfort. Once implanted, the system may present the opportunity for infection, erosion, product migration or device malfunction, which may require additional surgery.

Sterilization and StorageAll components and accessories of the Coloplast Virtue Male Sling are sterilized prior to shipping. When stored in normal conditions and the sterile barriers remain intact, the components will remain sterile until the expiration date. Always check the expiration date prior to use. Do not use product past the expiration date. Prior to use, check all sterile packaging to ensure it is intact and no sterile barriers are breached.

The product should be stored in a clean, dry, and temperature controlled environment per hospital protocol and out of direct sunlight. For best protection during storage, keep all component trays inside their original boxes.

IndicationsThe Coloplast Virtue Male Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence.Contraindications:The product is contraindicated for the following patients: with urinary tract infections or urinary tract obstruction; with blood coagulation disorders or prescribed anticoagulation therapy; with obstructive uropathy; under the age of 18.Warnings Carefully consider the risks and benefits of implantation in patients with the following: persistence of de novo incontinence; good bladder function and low volume detrusor overactivity; presence of bladder neck or urethral strictures; blood coagulation disorders, renal insufficiency due to urinary tract obstruction, or compromised immune systems.The patient should not have an active infection at the time of implantation.Precautions: It is the responsibility of the surgeon to advise the prospective patients or their representatives, prior to surgery, of the possible warnings associated with the use of this product.This product should only be used by surgeons who are qualified to perform this type of surgery, and who are familiar with the use of non-absorbable mesh and the specific insertion technique for Virtue.A 6-month period of non-invasive treatment is recommended before a sling implant is considered for males with stress urinary incontinence.Adverse Reactions:Local irritation, a foreign body response, wound dehiscence, extrusion, erosion, inflammation, fistula formation, urethral erosion, infection, bladder, urethra, vessel, nerve perforation. Other known risks of incontinence surgical procedures include sling migration, pain, transient or permanent retention, bladder outlet obstruction, and, continued stress urinary incontinence and persistent or new overactive bladder symptoms. The occurrence of these responses may require operative intervention with removal of part of or the complete sling.

Consult the Virtue Male Sling System Instructions For Use for detailed information regarding the implant procedure, contraindications, warnings, precautions, and potential complications/adverse events. For further information, call Coloplast Corp at 800.258.3476 and/or consult the company website at www.coloplast.com.Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.