A Randomized Comparison of Transobturator Tape with the Plication of Urethral Ligaments in the Treatment of Stress Urinary Incontinence.

Introduction and hypothesis: The new urethral ligament plication (ULP) operation for curing SUI is tape free. Instead of using a tape, the pubourethral ligament (PUL) is prevented from lengthening to cause urine loss on effort by a single collagen-creating polyester suture that confines all four branches of the PUL and adds new collagen to strengthen the ligaments. Its anatomical basis is identical to that for the midurethral sling (MUS).

Methods: The 108 patients were randomized by computer, 54 in each arm. Informed consent was obtained. The transobturator tape (TOT) technique was standard outside/in. The ULP technique is a bilateral operation. Two 4-cm full-thickness vaginal incisions were made in the paraurethral anterolateral vaginal sulci extending from the bladder neck to the lateral external urethral meatus on each side of the urethra. The incisions were opened up to reveal the PULs. A No. 2 collagen-creating polyester suture was inserted into the four PUL attachment points: midurethra; retropubic; external urethral ligament; pubococcygeus muscle.

Results: The ULP was found to be superior to conventional TOT in all measures. Cure rates were 90.7% vs 81.5% (p < 0.05), Urinary Distress Inventory-6 (UDI-6) scores were 0.61 vs 1.17 (p < 0.05), and operating time was 18 min vs 26 min (p > 0.06) respectively. Complications of the TOT were pain (7.4%), mesh erosion/extrusion (7.4%). The ULP had no significant complications. Results were independently confirmed by an external reviewer.

Conclusions: The ULP is low-cost ($2 for the polyester sutures), safe, direct-vision surgery (no blind insertion instruments to damage organs, vessels, or nerves) with a shallow learning curve. Minimal facilities are required, with a local anesthetic option.