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Title: Monarc Transobturator Sling Proven Safe and Effective for Stress Urinary Incontinence: Presented at AUGS

"Monarc Transobturator Sling Proven Safe and Effective for Stress Urinary Incontinence: Presented at AUGS"

By Mike Fillon ATLANTA, GA -- September 19, 2005 -- The Monarc(TM) Transobturator Sling is both safe and comparable to other procedures for stress urinary incontinence (SUI) women, including the suprapubic arch and transvaginal tape, and the open abdominal anterior urethropexy procedures (Burch or Marshall-Marchetti-Krantz). Lead researcher Robert Moore, MD, Director of Advanced Pelvic Surgery, and Co-director of Urogynecology, Atlanta Urogynecology Associates, Atlanta, Georgia, United States, presented results of a study that evaluated the Monarc sling here on September 15[^th at the 26^th Annual Scientific Meeting of The American Urogynecologic Society here in Atlanta (AUGS).

The Monarc is a tension-free midurethral sling developed by American Medical Systems of Minnetonka, Minnesota, United States. Dr. Moore said his study was the largest, prospective, U.S. multicenter trial to evaluate the device.

Dr. Moore and colleagues implanted the Monarc sling in 116 women with confirmed SUI from urethral hypermobility with or without intrinsic sphincter deficiency.

Preoperative evaluation included urodynamic testing, cough-stress test, Q-Tip test, 1-hour pad test and Pelvic Organ Prolapse Quantification. Each subject completed two quality of life questionnaires. Subjects were evaluated and completed all questionnaires prior to undergoing the procedure after 4 and 8 weeks, and at 6 months.

At 12 months, the objective cure rate was 81.6% on the cough stress test and the subjective patient/physician evaluations of continence was 82.5% (completely dry or substantially continent.)

"This [data], combined with no incidents of vascular, bowel or bladder perforations, suggests that Monarc is a safe and effective treatment of stress urinary incontinence," Dr. Moore said.

Additional benefits observed in the study population were a low rate of need for catheter at hospital discharge and minimal voiding dysfunction, he added.

"This [study] gives us critical data that has been unavailable to date," he noted.

The Monarc Transobturator Sling involves the placing of a narrow strip of mesh to support the urethra. Also known as the Monarc Subfascial Hammock(TM) or ObTape trans-obturator tape(TM), it eliminates potential complications that stem from blindly passing a large needle carrier through the retropubic space. Serious complications with the upward or downward vaginal passage of trocars have been reported with injury to the bladder, bowel, pelvic arteries, veins and nerves. The Monarc procedure reduces the risk of these complications.

The half-inch mesh is introduced under the urethra during an outpatient or short stay procedures that takes about 15 to 20 minutes. By remaining subfascial, operating below the vital pelvic structures, the transobturator approach eliminates the risk of injury to bladder, bowel or major vessels. Cystoscopy is not required in most cases, unlike other retropubic sling procedures.

Dr. Moore said that because of the safety and simplicity of the Monarc procedure, older women who were previously denied the more extensive retropubic sling procedures could now have an alternative procedure that will permanently rid them of stress incontinence.

[Presentation title: Monarc Transobturator Sling for the Treatment of Stress Urinary Incontinence: Interim Results of a US Multi-center Prospective Study on 112 Patients. Poster 50]

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