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Update on Neuromodulation and New Options for Stress Urinary Incontinence

This report is based on medical evidence presented at sanctioned medical congress, from peer reviewed literature or opinion provided by a qualified healthcare practitioner. The consumption of the information contained within this report is intended for qualified Canadian healthcare practitioners only.

2006 Annual Society for Urodynamics and Female Urology Meeting

Port Lucaya, Bahamas / February 22-25, 2006

Excellent control of severe stress incontinence may be achieved through the use of Adjustable Continence Therapy or ACT™ (ACT™ is for women; the same system for men is known as ProACT™). Dr. Ervin Kocjancic, University Hospital of Udina, Italy, reported on a series of 67 patients with severe stress incontinence due to intrinsic sphincter deficiency. At a mean follow-up of 36 months, patients reported a statistically significant increase in quality of life, a dramatic reduction in pad usage, with 72% of patients considering themselves dry, and an additional 16% considering themselves much improved, defined as no more than one pad a day following device placement. Based on these results, the overall success rate in the trial was reported as 88%.

As Dr. Kocjancic noted, the volume of the system usually takes a few adjustments and some patients may not experience any improvement in quality of life for the first three months. But the beauty of this device, he noted, rests in its easy adjustability. Following bilateral placement of two small implants at the bladder neck, “you can adjust the volume afterwards, meaning that you can titrate the proper resistance after the surgery and you can do this three to four years after the procedure so you do not need to go to the operating room to revise it,” Dr. Kocjancic told delegates.

The adjustment can also be done right in the office by simply accessing an internal port with a simple syringe and either inflating or deflating the volume of the balloons, he added. In his experience, device placement does not lead to voiding or sexual dysfunction and the procedure is easily learned by skilled gynecological surgeons.

“ACT™ is the final choice before going to an artificial sphincter for women, but ProACT™ in males is the first choice for treating incontinence because it is much less invasive [than other strategies] and results are very good,” Dr. Kocjancic concluded.

Under-reporting of Tape and Sling Complications

According to Dr. Shlomo Raz, University of California School of Medicine, Los Angeles, complications following minimally invasive sling surgeries may not be as low as generally believed. In their own experience from 2001 to 2004, 26 patients developed major complications following sling placement, 13 after the transvaginal tape (TVT), nine after suprapubic arch sling and four after the transobturator tape (TOT). “At exploration, most of the patients were found to have mesh in the urethra,” investigators noted. “More astounding,” they added, were major complications reported to the US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience database, a voluntary process where surgeons may report malfunction of surgical devices. During the same four years, 700 major complications had been reported to the FDA, including eight deaths following TVT. Complications included urethral necrosis, bowel perforation, pelvic abscesses, vascular and urethral injury and nerve entrapment. “These minimally invasive surgeries also cause more bleeding than we think,” Dr. Raz told delegates, “and we are clearly under-reporting complications from these procedures.”

Neuromodulation Therapy

Sacral nerve stimulation (SNS), as provided by the InterStim™ implantable neurostimulator, significantly reduces symptoms of incontinence and improves quality of life in the majority of patients with refractory urge incontinence, a long-term study shows. For the study, researchers evaluated patient satisfaction following implantation of the InterStim™ system in a total of 52 patients (four of them male). The average interval between receipt of the implant and completion of the questionnaire was 27.2 months. Patients were judged to be satisfied with the procedure if they indicated they were “somewhat better” or “much better” and if they would undergo the procedure again.

As reported by Dr. Cindy Amundsen, Associate Professor of Obstetrics and Gynecology, Duke University Medical Center, North Carolina, findings indicated that nearly 80% of the patient cohort “would do it all over again,” while 84% were satisfied with the procedure. Eight patients indicated that they were dissatisfied with the procedure, but this may be explained by the lower reduction in daily pad usage among dissatisfied subjects compared with those who reported they were satisfied.

“Patients who were satisfied also had an 84.5% reduction in pad weight, whereas the dissatisfied group had only about a 60% reduction in pad weight,” Dr. Amundsen noted, adding that “more dramatic improvement” in symptoms may be required for patient satisfaction than is currently required to obtain permanent implantation.

Young, healthy, neurogenically intact patients are most likely to achieve either a “cure” or “nearly dry” status with SNS, Dr. Amundsen noted. In contrast, older women, as well as patients with comorbidities, including spinal cord injuries, Parkinson’s patients and stroke victims, are less likely to achieve as high a response rate and chronic retention patients may similarly respond less well to SNS. A longer test stimulation period out to a month instead of the standard three to five days may improve response to SNS in patients who are less likely to respond to SNS, Dr. Amundsen suggested.

Prior to the introduction of new tined leads in the InterStim™ system, surgical reintervention rates to repair lead migration approached 40%. But as discussed by Dr. Jerzy Gajewski, Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, improvements in the equipment including the introduction of tined leads—along with physician experience in implanting the system—has significantly reduced the need for reintervention. Dr. Gajewski reported that in his group’s early experience with SNS implantation, two-thirds of patients who received the implant required surgical reintervention. Currently, this rate has dropped to approximately one-third of patients, he added.

Other physicians, including Dr. Paul Pettit, Mayo Clinic, Jacksonville, Florida, and colleagues, have achieved even lower rates of surgical revision after implantation of the device using exclusively tined leads. In their own review of the last 105 patients undergoing SNS for pelvic floor disorders, the surgical reintervention rate was only 10.4%. “Since the switch to the tined lead, there have been no fractures of the quadrapolar leads,” they reported, “and we feel our revision rates are low because of the use of special skin preparation and shield.”

Cost Effectiveness

A strong economic argument can also be made for the use of the SNS implant to treat refractory voiding dysfunction. In a retrospective review of 65 such patients who had received InterStim™ therapy, Kaiser Permanente investigators found that healthcare costs and healthcare utilization dropped significantly following receipt of the implant. Compared with one year prior to implantation, there was a significant decrease in the number of diagnostic evaluations in the year following the implant, noted Dr. Sherif Aboseif, Director, Neuro-Urology and Reconstructive Surgery, Kaiser Permanente Los Angeles Medical Center, California.

As well, the number of urinary tract infections, out-patient visits for urinary symptoms, pad utilization and catheterization rates all significantly decreased following implantation compared with the previous 12 months. “There was also a 32% decrease in drug utilization rates,” Dr. Aboseif added. Complication rates were also under 20% in this particular series, with only three devices requiring removal, two for infection and one for malfunction. “Based upon our findings, I think InterStim™ therapy is a viable and economic treatment when used in a properly selected patient population,” Dr. Aboseif stated.

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