Infla10® Pulse™Also Known As
Bone-anchored suburethral synthetic sling, InVance male sling, bone-anchored perineal male sling, bone-anchored suburethral sling, pubic bone-anchored male sling, bone-anchored urethral sling, bone-anchored male suburethral sling, perineal bone-anchored male sling, Straight-In bone anchoring system, fixed male sling
Definition
The Bone-Anchored Male Sling is a minimally invasive surgical device designed to treat stress urinary incontinence (SUI) in men, particularly following prostate surgery1. This procedure involves the placement of a synthetic mesh or biological material sling beneath the bulbar urethra, which is anchored directly to the pubic bone using specialized bone screws or anchors2,4.
The sling functions by providing compression and support to the bulbar urethra, effectively increasing urethral resistance and promoting urethral coaptation5. This mechanism helps prevent involuntary urine leakage during activities that increase intra-abdominal pressure, such as coughing, sneezing, or physical exertion1,3.
The bone-anchored approach ensures secure fixation of the sling, allowing for precise tension adjustment during the procedure to achieve optimal urethral compression without causing urinary obstruction2,4. Urethral resistance is typically increased to 30-50 cm water above baseline pressure during the procedure1.
This surgical intervention is primarily indicated for men with mild to moderate stress urinary incontinence resulting from intrinsic sphincter deficiency, most commonly following radical prostatectomy, robot-assisted laparoscopic prostatectomy, or transurethral resection of the prostate3,4. The procedure is performed with the patient in the lithotomy position using a perineal approach, and it aims to restore continence while preserving normal voiding function1,2.
Clinical studies have demonstrated success rates ranging from 40% to 88% for the bone-anchored male sling, with some series reporting sustained efficacy at medium to long-term follow-up of 36-48 months6,7. The procedure offers advantages including immediate continence improvement, minimal postoperative adjustments, and relatively low morbidity when performed in appropriately selected patients3,4.
Clinical Context
The Bone-Anchored Male Sling is primarily indicated for the treatment of stress urinary incontinence (SUI) in men following prostate surgery, particularly radical prostatectomy, robot-assisted laparoscopic prostatectomy, or transurethral resection of the prostate1,2,3. This condition results from intrinsic sphincter deficiency, where the urethral sphincter mechanism is compromised, leading to involuntary urine leakage during activities that increase intra-abdominal pressure4.
Patient Selection Criteria
Optimal candidates for the bone-anchored male sling are men with mild to moderate stress urinary incontinence, typically defined as using 0-2 pads per day or having a 24-hour pad weight of less than 500 grams4,5. Some experts suggest a more conservative threshold of 150 grams or less in a 24-hour pad test as a cutoff indication for sling placement4. Patients should demonstrate some degree of residual voluntary sphincter function, which can be evaluated through urodynamic studies or awake cystoscopy4.
The procedure may be considered for patients who have not responded adequately to conservative management approaches such as pelvic floor exercises4,6. While a history of pelvic radiotherapy is not an absolute contraindication, it has been identified as a strong predictor of treatment failure, with studies showing significantly lower success rates in irradiated patients3,7.
Surgical Procedure
The bone-anchored male sling procedure is performed with the patient in the lithotomy position using a perineal approach1,2. The technique involves placing four miniature bone screws with pre-attached pairs of polypropylene sutures directly into the medial aspect of the inferior rami of the pubic bone1. A pair of bone anchors is positioned just below the symphysis on each side, with a second pair inserted 3-4 cm lower1.
A trapezoid-shaped sling made of synthetic material (such as polyethylene terephthalate) or biological material (such as cadaveric fascia lata) is then secured to the pubic bone using the sutures attached to the bone anchors1,2. The sling is positioned to support the bulbar urethra, and tension is adjusted to increase urethral resistance by 30-50 cm water above baseline pressure1. This calibrated tension adjustment is crucial to achieve the optimal balance between continence and voiding function1,2.
Expected Outcomes
Clinical studies have reported success rates ranging from 40% to 88% for the bone-anchored male sling2,6,7. In one long-term study with a median follow-up of 36 months, 76% of patients achieved successful outcomes, with 36% completely dry and 40% significantly improved (reduced to one or two pads per day)2. Another study with a mean follow-up of 35.2 months reported that 55% of patients were cured (defined as dry with pad weight of 0-1 gram) and 12.5% were improved3.
Recovery typically involves minimal hospital stay, with patients often discharged on the same day or after overnight observation2. Most patients can return to normal daily activities within 2-6 weeks, though restrictions on heavy lifting and strenuous activities may be recommended for 4-6 weeks4.
Complications are generally minimal but may include perineal pain (reported in up to 73% of patients, typically resolving within 1-3 months), mesh infection (reported in approximately 15% of cases), and rarely, erosion3. No significant urethral erosion or osseous complications have been reported in major studies1,3. Postoperative urodynamic studies typically show no signs of bladder outlet obstruction2.