ATLANTA — The promising results seen in initial studies of SURx transvaginal radio frequency for the treatment of stress urinary incontinence were not replicated in a recent series of patients.
“We were unable to replicate previously reported response with the SURx procedure despite adequate technique, and although we found it to be safe, we have decided not to continue to offer this as a treatment option for our patients,” Dr. Gunhilde Buchsbaum said at the annual meeting of the American Urogynecologic Society.
Initial studies of the SURx system, which was approved for use in the United States in 1997, showed cure rates and patient satisfaction rates in the 80% range. In the current study comprising 15 patients treated at the University of Rochester (N.Y.) Medical Center from January 2003 to April 2004, the success rate was low, patient satisfaction was low, and the rate of additional treatment was high, said Dr. Buchsbaum of the departments of obstetrics and gynecology, and urology at the university.
Before treatment, all patients had a mean Valsalva leak-point pressure (VLPP) of 150 cm H2O, and seven had concomitant urge. The mean number of leaks per day was about six. The patients were treated with a total radio frequency application time of 188 seconds for both sides. There were no complications.
After surgery, 6 of the 15 patients had a negative cough stress test, and 9 reported ongoing stress urinary incontinence symptoms and had a positive cough stress test. The average number of leaks per day in those with ongoing symptoms was reduced from six to four.
Five patients said they were extremely satisfied with the procedure, one was satisfied, and nine were not satisfied. Seven patients sought additional treatment within a year; four had tension-free vaginal tape placement, one had Burch colposuspension, and two were fitted with a continence ring.
The treatment was discontinued at the medical center because the 40% cure rate was deemed unacceptable, Dr. Buchsbaum said. “Every procedure has a learning curve; however …it is important for any procedure marketed for widespread use to have minimal operator dependency,” she said.