We presented data on the NeuroSAFE PROOF study which is a randomised controlled trial to evaluate the effect of the NeuroSAFE intervention, which is a frozen section intraoperative margin evaluation, on continence and potency following radical prostatectomy.
What did you do?
We recruited 400 men across five UK NHS centres and we randomised those men, they were all potent and continent of urine to start with. They were all men who were having radical prostatectomy. We randomised them 1:1, 50% of those patients had surgery with the NeuroSAFE intervention and 50% had their surgery according to a pre-operative plan based on their clinical parameters – biopsy results, MRI scans, PSA levels and so forth.
We used patient-reported outcome measures to look at their potency and continence at 3, 6 and 12 months following surgery. The primary outcome for the study was the level of sexual potency measured using the IIEF-5 questionnaire at 12 months postoperatively.
What did you find?
We found that there was a significant difference in favour of the use of NeuroSAFE, to using the procedure during robotic radical prostatectomy. This translated into an increase in sexual potency measured at 12 months with almost twice as many men having no or mild erectile dysfunction in the NeuroSAFE group, compared to the standard arm.
What could be the implication of these results?
It would seem that by using NeuroSAFE we are able to allow more men the opportunity to regain their sexual function after robotic radical prostatectomy.
What is your take-home message for clinicians?
This is something you should be trying to incorporate into your clinical practice. We appreciate that the intervention itself is quite laborious and time-consuming but this is an intervention which seems to be worthwhile if the objective is to get as good an outcome as possible for your patients.