Management of benign prostatic hyperplasia (BPH) is traditionally administered via surgical methods such as transurethral resection of the prostrate (TURP). Though fairly successful and safe, these techniques are operator dependent and often have significant side effects. Consequently, intensive research has been applied in the development of non-invasive therapies, overcoming the need for general anesthesia and with minimal incontinence and sexual dysfunction post-surgical problems.
A recent review describes the most recent surgical techniques and their stage of clinical trial development for the treatment of common disease-caused lower urinary tract symptoms (LUTS). The review, entitled “Evolving and investigational therapies for benign prostatic hyperplasia,” was published in The Canadian Journal of Urology and revealed:
- Two promising new drugs, NX-1207 and PRX-302, are currently in pre-clinical development for use in intra-prostatic injections. NX-1207, a protein that induces apoptosis (cell death) and reduces prostrate volume, is being developed by Nymox Pharmaceutical Corporation and is currently in phase III clinical trials. Results from two phase II clinical trials indicate that the drug was successful at prostate volume reduction with more than 50% of patients not requiring further surgical interventions at 5 years of follow-up. No significant side effects were reported. PRX-302, also an apoptotic agent, completed phase II clinical trials, demonstrating significant decrease in IPSS (International Prostate Symptom Score, a questionnaire to access urinary symptoms and quality of life) and no significant side effects, however, researchers also report a significant placebo effect. Both drugs have the great advantage of not needing special trained operators or special equipments.
- Aquablation, a procedure involving a robot under transrectal ultrasound guidance that dispenses a saline stream in high-velocity to reduce prostatic tissue, presents several advantages — namely, no special training required for the operator with surgical time and efficiency independent of prostate size. Phase I and II clinical studies have demonstrated positive results with prostate volume reduction and improvement of IPSS. No complications were reported, though efficacy and safety have yet to be validated.
- The Rezum system consists in the ablation of prostate tissue by water vapor created by radio frequency, requiring only local anesthetics. Results of Phase I clinical trials have shown improvements in IPSS and reduction of total volume of the prostate, with mild adverse effects. Clinical studies are undergoing to prove this procedure’s long-term efficacy.
- Non-surgical procedure prostatic artery embolization (PAE) reduces prostate volume by injection of an embolic agent, usually ethanol based, into the prostatic artery, avoiding the need of general anesthesia. Several clinical trials have reported a success rate greater than 90%, with some complications being reported, but mostly of transient nature. Incontinence and erectile dysfunction have not been reported. Despite such success, a clinical failure with need for subsequent surgical intervention has also been observed. A clinical multi-center study is currently in development in the U.K. to compare this method efficacy with TURP. The main disadvantage of this technique is the need for a specialized radiologist and its current unpredictability.
- Histotripsy technology found great popularity due to its ideal profile for real time ultrasound monitoring. It involves the use of ultrasound energy to induce high intensity pressure changes in the tissue, which lead to mechanical tissue fractionation. Despite promising results in canine models, safety concerns and a poor enrollment rate in human trials raise doubts of this technique’s future in the clinic.
The investigational studies of new therapies and technologies to resolve BPH symptoms have yielded some promising techniques. Results from undergoing clinical trials will hopefully confirm these technologies as non-invasive and safe procedures for future therapies.