The EXPANDER-1 trial: introduction of the novel Urocross™ Expander System for treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).

ABSTRACT:

Purpose

To demonstrate the safety and feasibility of the Urocross Expander System (formerly branded as XFLO Expander System), an implantable nitinol tissue expander to trea t patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).

Materials and methods

Men of 50 years or older were eligible to participate in the international, prospective, three-arm, open-label EXPANDER-1 trial if they had a prostate volume between 30 and 80 cc, prostatic urethra length between 20 and 60/80 mm, international prostate symptom score (IPSS) > 13, peak urinary flow (Qmax) < 12 mL/s, post-void residual (PVR) urine volume < 250 mL and quality of life (QoL) score ≥ 3. Patients had pre-assigned implant indwell times (1, 6, and 12 months for Arm-1, Arm-2 and Arm-3

SUBMITTER: Woo HH 

PROVIDER: S-EPMC9385491 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature