Clinical Research Directory

Ultrasound-Guided vs. Conventional Prostate Suspension in BPH: An Exploratory Study

Sponsor: Shanghai East Hospital

Summary

This is an exploratory, prospective, single-center, open-label, 1:1 randomized controlled study. The study compares two surgical methods for benign prostatic hyperplasia (BPH): ultrasound-guided prostate suspension and conventional prostate suspension. BPH is a common condition in older men that can cause lower urinary tract symptoms (LUTS), such as frequent urination, weak urine stream, and difficulty emptying the bladder. The purpose of this study is to learn whether using ultrasound guidance during prostate suspension can improve urinary symptoms and urine flow more than the standard procedure, while preserving sexual function and maintaining safety. About 20 men aged 50-80 years with BPH and bothersome LUTS will be enrolled. Eligible participants must have an IPSS score of 12 or higher, a maximum urine flow rate (Qmax) of 15 mL/s or less, a prostate volume of 30-100 mL, and a post-void residual urine (PVR) of 250 mL or less. They must be dissatisfied with medication or refuse long-term medication and be able to give informed consent. Men with prior prostate surgery, suspected or confirmed prostate cancer, neurogenic bladder, urethral stricture, bladder neck contracture, bladder stones, recurrent urinary tract infection, active urinary infection, bleeding disorders, acute urinary retention, or current participation in another interventional trial cannot take part. Participants will be randomly assigned in a 1:1 ratio to the experimental group or the control group. The experimental group will receive ultrasound-guided prostate suspension. In this procedure, the standard UroLift prostate suspension is performed with ultrasound guidance, and at least one additional suspension implant is placed on each side. The control group will receive the standard NeoTract UroLift System procedure. Both procedures are minimally invasive and are performed through the urethra without cutting prostate tissue. The study is open-label, meaning participants and surgeons know which procedure is used, but the staff who assess outcomes will be blinded to group assignment to reduce bias. The main outcome is the change in IPSS at 12 months after surgery. Secondary outcomes include changes in Qmax, quality of life (IPSS-QoL), PVR, sexual function (IIEF-5), complications, and retreatment rate. Follow-up visits will occur at about 1, 3, 6, and 12 months after surgery. The total study duration is about 36 months. All surgery has risks. Possible risks include bleeding, infection, pain, urinary symptoms, urinary retention, implant-related problems, or the need for further treatment. The study team will monitor participants closely and provide standard medical care as needed. This study may help doctors understand whether ultrasound-guided prostate suspension offers better symptom relief than the standard procedure. Participation is voluntary, and participants may withdraw at any time without affecting their usual medical care.

Official title: An Exploratory Study of Ultrasound-Guided Prostate Suspension Versus Conventional Prostate Suspension in the Treatment of Benign Prostatic Hyperplasia

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