Dr. Ghoniem on detrusor nerve radiofrequency ablation research

In this video, Gamal M. Ghoniem, MD, FACS, ABU/FPMRS, gives an overview of the DENERA trial. Ghoniem is Emeritus Professor of Urology at UCI School of Medicine.

Transcription:

Please provide an overview of the DENERA trial.

Translational research is very important. You look for the defect, and you try to treat it based on facts. That works well for medicine and oncology; however, it [doesn't] work for surgery. The other way around most of the surgical achievements we have [is] we do it based on experience and then try to find the reasons why it works. [This] approach is not very good, especially for outcomes. [Across] 100 years of dealing with stress urinary incontinence in females, probably over 100 surgical procedures have been offered. With DENERA, [it was] the reverse; I tried to take the concept of finding out what's wrong first before we treat. Observation wise, when I was working with Dr. Ed McGuire back at Tulane, it was called urgency frequency syndrome. We started to do an abbreviated bladder denervation, doing a transvaginal approach doing an inverted U and trying to burn the nerves. The results were decent; a 60% to 70% success rate. However, the longevity outcome goes out by time. I tried to be more selective, so I did what's called a subtrigonal marking test to inject freezing material under the trigone and see if patients improve temporarily, for a day or so, then they can go to surgery. However, it's not logical to go back in and do the surgery again and again, especially in a young woman, so that [was] kind of abandoned. Coming back to UCI here, I started to look into it again in the past 8 to 9 years. One of the things I worked on with Dr. Landman was trying to find a model. We have a female pig, and we try radiofrequency at different temperatures. That study was published in the gold journal. We found [an] effect on the nerve, but at higher temperature, there were also effects, or if you want to call it collateral damage, to the technique. It was done transurethrally. At that point, it came to me: Why don't we do a transvaginal approach and refine the whole thing? And I did have a patent on the transvaginal approach for doing this. And then we started the anatomy, and probably we were the first people really to redefine the anatomy in 3D to the lower urinary tract, and that was published in the Journal of Urology in 2016/2017. We found the condensation of the autonomic nerve is under the trigone and probably proximal urethra too. That was done on human cadavers. Then I took the idea, and with the help of UCI innovations, I was awarded a grant and bioengineering department at UCI as well. We'll work all together and develop a better model after searching the literature. Female sheep [have] very close anatomy to the human and [are] very suitable for female pelvic reconstructive and other experiments in that area. So after bench work, just trying to define the anatomy, the feasibility, fine tuning the program to work with radiofrequency, we developed a probe in an animal model. That was the basis of the study that [was] published early this year on DENERA. In our study, in summary, we found that gentle radiofrequency, meaning temperature is low, can indeed cause nerve changes without doing collateral damage. We had these animals, we tested them from the beginning as controls and then 4 weeks and 1 month and 3 months, and at 3 months, we started to see some regeneration of the autonomic nerve. We used the special stains like S100; that was published in Neurourology and Urodynamics. After that, the second logical step is [testing in humans]. Having a procedure done in the clinic with just local anesthetic and almost no pain is like a dream. If a lady comes in the office, has the procedure in less than half an hour and drives her car and goes home and hasgood results, then that would be really the success that we're looking for. No anesthesia and not going to the OR, or even post procedure problems like dysuria and hematuria, because we don't go through the urethra. At the same time, a Chinese group published on a transurethral approach with radiofrequency, and [those were] good results. So in general, I think controlled radiofrequency is a new innovation, just getting into the overactive bladder fields. I think having success with that in humans will make it very, very valuable for the practicing urologist that can be done in the clinic without much training or anything like that.

This transcription was edited for clarity.