Researchers say a cooling device can reduce local inflammation and shorten time to continence-and even prevent permanent incontinence-in patients who undergo robot-assisted radical prostatectomy.
Orange, CA-Researchers say a cooling device can reduce local inflammation and shorten time to continence-and even prevent permanent incontinence-in patients who undergo robot-assisted radical prostatectomy (RARP).
The device cycles cold saline solution into a balloon in the rectum during the prostatectomy procedure. It appears to work by decreasing the metabolic rate in cells and reducing inflammatory damage to sensitive tissues, the authors reported.
“If you can preserve your continence, it will be worth it,” said senior author Thomas Ahlering, MD, professor and vice chair of urology at the University of California, Irvine.
Dr. Ahlering said he has long wondered why older prostatectomy patients were much more likely to suffer from incontinence than younger ones even after undergoing identical procedures. He found that all patients aged 50 years and younger would become continent over time. Most would no longer need a pad within 6 months. However, only 65% to 70% of those aged 70 years and older would regain continence.
While sexual function is important, incontinence is “the most feared side effect” among these patients, first author Blanca Morales, BS, a research associate at UC Irvine, told Urology Times.
Dr. Ahlering developed the cooling device, which is linked to a small refrigerator and circulates sterile saline cooled to 40°F, about the temperature of a cold can of soda. The idea is to remove heat from the pelvic area.
“The balloon is only in there during the course of surgery,” Dr. Ahlering explained. “The balloon is double-walled. If it were to start leaking for some reason, it would only leak out cold saline.”
For the study, which was presented at the AUA annual meeting in San Diego, the authors evaluated a control group of 58 patients who underwent RARP and 52 who underwent RARP with hypothermia (hRARP). The control and hRARP groups were similar in age (about 61 years), pre-op PSA (5.8 ng/mL vs. 5.0 ng/mL), AUA Symptom Score (8.1 vs. 8.0), bother score (1.4 vs. 1.5), International Index of Erectile Function-5 (19.9 vs. 20.2), body mass index (26.0 kg/m2 vs. 26.5 kg/m2), prostate weight (52.4 vs. 52.3 grams), Gleason score (6.7 in both), and pre- and postoperative whole blood neutrophil counts.
The median time to zero-pad continence was significantly shorter for hRARP patients (22 vs. 64 days) compared to controls (p<.001). The authors also found that the mean number of localized neutrophil counts-a sign of inflammation-fell by about 50% in hRARP patients versus controls (p=.002).
The researchers also discovered that inflammation was higher in older patients, a finding that could explain why they suffer from more lasting incontinence.
Dr. Ahlering said there were no adverse effects associated with the device.
“It’s basically impossible for hypothermia to cause an injury,” he said.
It’s not clear yet whether the chilling therapy will lower sexual-function side effects. But two patients reported an unexpected benefit: Their hemorrhoids improved after treatment.
Researchers will finish a randomized controlled trial in 200 men by the end of this year in hopes of gaining FDA approval and making localized hypothermia standard of care in all robotic prostatectomy patients.
Dr. Ahlering is a consultant/adviser to Astellas Pharma Global Development, Inc. and Philips Healthcare.UT
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