Novel minimally-invasive BPH device shows early promise

The XFLO Expander System, a minimally invasive treatment for benign prostatic hyperplasia (BPH), showed clinical promise for immediate relief of BPH-related lower urinary tract symptoms (LUTS) without sacrificing sexual function.¹

Interim results from the EXPANDER-1 trial (NCT03758222) showed that the novel, reversible, office-based XFLO system provided patients with symptom relief within 2 weeks post-implant. Among patients with a dwell time of up to 6 months, there was a 40% reduction in International Prostate Symptom Score. Efficacy of XFLO was sustained at 6 months after retrieval of the implant. The investigators are continuing long-term follow-up for further efficacy and safety end points.

"Currently available BPH medications are often insufficiently effective or involve side effects, including but not limited to sexual dysfunction and compromised quality of life, which result in 66% of patients discontinuing medication within 1 year. Surgical treatments are known to not only involve bleeding and temporary catheterization, but also result in permanent tissue damage and irreversible side effects including ejaculatory dysfunction,” Henry Woo, MBBS, DMedSc FRACS, a world-renowned urological surgeon and professor of Surgery at the University of Sydney, Australia, stated in a press release.

“There is a strong need for an alternative minimally invasive solutions that offer rapid relief from BPH/LUTS and have no risk of urinary incontinence or impact on sexual function,” added Woo.

According to Medeon Biodesign, XFLO involves using a low-profile delivery catheter and a standard flexible cystoscope to insert an expander implant in the prostatic urethra. The urethra, which has been narrowed in the patient because of the enlargement of the prostatic lobes, is then opened by the implant. Retrieval of the XFLO can be done with a standard flexible cystoscope and the XPRO Retrieval Sheath in an office setting.

The ongoing, nonrandomized, open-label EXPANDER-1 clinical study is being conducted at clinical sites in Australia, Republic of Georgia, Canada, and Taiwan. The target enrollment for the trial is 70 patients. Enrollment criteria include age ≥50 years; symptomatic BPH and related LUTS; a prostate volume of 30 to 80 cc as measured by abdominal ultrasound or transrectal ultrasound; and a prostatic urethra length of 2.0 cm to 6.0 cm.

Exclusion criteria for the trial include prior BPH procedure; cystolithiasis within the previous 3 months; positive cancer biopsy; PSA level ≥10 ng/mL, unless there is a negative biopsy; and urethral stricture, meatal stenosis, or bladder neck obstruction.

"The early clinical results indicate the XFLO Expander System could be a promising new minimally invasive therapy for BPH patients. It can provide rapid and effective relief from lower urinary tract symptoms, without compromising sexual function. The reversible nature of the solution can also preserve future treatment options for patients, if needed," Chi-Ping Huang, MD, director of Urology at China Medical University Hospital in Taichung, Taiwan, stated in the press release.

Reference

1. Medeon Announces Positive Clinical Results for XFLO Minimally Invasive BPH Treatment Device. Published online January 27, 2021. Accessed February 9, 2021. https://prn.to/2Z0Udzc