Source: Placenta  |  Posted 9 years ago

By Ed Susman
Special to DG News

LOS ANGELES, CA -- May 9, 2002 -- Laparoscopy combined with radiofrequency thermal energy treated genuine stress incontinence with an 85 percent success rate, according to research presented at the 50th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists (ACOG).

"This is a safe and easy-to-use system that the practicing gynecologist can master," said Donald I. Galen, MD, surgical director of the Reproductive Science Center of the San Francisco Bay Area, San Ramon, California.

The procedure can be accomplished in about an hour, he said. The treatment heats, shrinks, and stabilizes the endopelvic fascia, thereby increasing support of the proximal urethra and bladder neck.

The FDA-approved system was developed by SURx of Livermore, California, which sponsored Dr. Galen?s study.

"Radiofrequency bladder neck suspension is a novel treatment for stress incontinence which aims to stabilize the [endopelvic fascia] adjacent to the bladder neck and proximal urethra without using implanted foreign material, sutures, or injectable bulking agents," he said.

Dr. Galen and colleagues recruited 94 women-average age 48 -- into the study, of whom 78 percent experienced one or more incontinence episodes a day. The patients had tried three months of Kegel exercises or pelvic floor electrical stimulation without success.

Radiofrequency was applied with a laparoscopic devise to shrink the endopelvic fascia. The women were followed at one-, three-, six-, and 12-month intervals; at one year there were 85 evaluable patients.

Dr. Galen reported that after one year, 85 percent of the women were using no more than one pad per day to control urinary leaks; 81 percent of the patients expressed satisfaction with the procedure and the results.

Complications during the procedure included two perforated bladders, which were not deemed device related; one superficial hematoma; and one case of hypotension. Post-procedure complications included two urinary tract infections, one trocar site infection, one case of nausea and vomiting, and one case of urinary urgency secondary to smoking.

Dr. Galen said that although the laparoscopic approach has been validated by his study, nonsurgical techniques such as a transvaginal approach also appear promising. No matter which procedure works best for individual doctors, he said, "this technology holds great promise for the treatment of genuine stress incontinence."