An interventional study of Ultrasound-Guided Prostatic Urethral Lift and Conventional Prostatic Urethral Lift in Benign Prostatic Hyperplasia, sponsored by Shanghai East Hospital. Not yet recruiting at 1 site in China. Open to male participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Shanghai East Hospital · Not applicable, Interventional, and Treatment
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.
803 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.
This study's planned enrollment of 20 is below the median of 96 across 610 interventional studies indexed under Prostatic Hyperplasia.
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International Prostate Symptom Score (IPSS) ≥12. Maximum urinary flow rate (Qmax) ≤15 mL/s (measured at a voided volume ≥125 mL).
Prostate volume 30-100 mL (measured by transrectal ultrasound or MRI). Post-void residual urine (PVR) ≤250 mL. Unsatisfactory response to medication or refusal of long-term medication. Signed informed consent. American Society of Anesthesiologists (ASA) physical status classification I-III.
Exclusion Criteria:
Confirmed or highly suspected prostate cancer (PSA >10 ng/mL or positive biopsy).
Neurogenic bladder dysfunction. Urethral stricture or bladder neck contracture. Bladder stones or recurrent urinary tract infection. Active urinary tract infection. Coagulation disorders. Acute urinary retention. Participation in another interventional clinical trial.
Participants undergo ultrasound-guided prostate suspension using the NeoTract UroLift System. Under ultrasound guidance, the UroLift delivery device is inserted transurethrally, and permanent nitinol implants are placed to pull the enlarged prostate lateral lobes outward and fix them toward the prostate capsule, thereby expanding the compressed urethra and relieving bladder outlet obstruction. Compared with the standard procedure, at least one additional set of suspension implants is placed on each side. No prostate tissue is resected. The procedure is minimally invasive and may be performed under local, spinal, or general anesthesia according to clinical practice. Postoperative care follows standard institutional protocols.
Procedure: Ultrasound-Guided Prostatic Urethral Lift
Participants undergo standard conventional prostate suspension using the NeoTract UroLift System without ultrasound guidance. Under direct cystoscopic visualization, the delivery device is inserted transurethrally, and permanent nitinol implants are typically placed 1-2 per side (2-4 implants total) to lift and fix the obstructing prostate lateral lobes, thereby expanding the urethra. No prostate tissue is resected. The procedure is generally performed under general anesthesia. A urinary catheter is usually left in place and removed after 1 day. Postoperative care follows standard institutional protocols.
Procedure: Conventional Prostatic Urethral Lift
A minimally invasive transurethral procedure using the NeoTract UroLift System. Under real-time ultrasound guidance in addition to standard cystoscopic visualization, permanent nitinol implants are placed to pull the enlarged prostate lateral lobes outward and secure them toward the prostate capsule, thereby expanding the compressed urethra and relieving bladder outlet obstruction. Compared with the conventional procedure, at least one additional set of suspension implants is placed on each side. No prostate tissue is resected. This intervention is distinguished from conventional PUL by the use of ultrasound guidance and the placement of additional implants.
Standard minimally invasive transurethral prostatic urethral lift using the NeoTract UroLift System under direct cystoscopic visualization without ultrasound guidance. Permanent nitinol implants are typically placed 1-2 per side (2-4 implants total) to lift and fix the obstructing prostate lateral lobes, expanding the urethra and relieving bladder outlet obstruction. No prostate tissue is resected. This is the conventional comparator procedure.
Change in International Prostate Symptom Score (IPSS) from Baseline to 12 Months After Surgery
Change in total IPSS score at 12 months after surgery compared with baseline (postoperative IPSS minus baseline IPSS). The IPSS is a 7-item questionnaire; total score ranges from 0 to 35, with higher scores indicating more severe lower urinary tract symptoms. The expected between-group difference is \>3 points.
Time frame: Baseline (preoperative) and 12 months after surgery
Change in Maximum Urinary Flow Rate (Qmax) at 3, 6, and 12 Months After Surgery Compared with Baseline
Change in Qmax (postoperative value minus baseline value). Qmax is measured by uroflowmetry; a voided volume of at least 125 mL is required for a valid measurement. Expected between-group difference: \>3 mL/s.
Time frame: Baseline and 3, 6, and 12 months after surgery
Change in International Prostate Symptom Score Quality of Life Item (IPSS-QoL) at 3, 6, and 12 Months After Surgery Compared with Baseline
Change in IPSS-QoL (Item 8 of the IPSS) from baseline. The IPSS-QoL is completed by the participant; higher scores indicate worse quality of life related to urinary symptoms.
Time frame: Baseline and 3, 6, and 12 months after surgery
Change in Post-Void Residual Urine (PVR) at 1, 3, 6, and 12 Months After Surgery Compared with Baseline
Change in PVR (postoperative value minus baseline value). PVR is measured by ultrasound and reflects bladder emptying function. Lower PVR indicates better bladder emptying.
Time frame: Baseline and 1, 3, 6, and 12 months after surgery
Change in International Index of Erectile Function-5 (IIEF-5) Score at 1 and 12 Months After Surgery Compared with Baseline
Change in IIEF-5 score (postoperative value minus baseline value). The IIEF-5 is used to assess sexual function, including erectile function. Higher scores indicate better sexual function.
Time frame: Baseline and 1 and 12 months after surgery
Incidence of Complications Graded by Clavien-Dindo Classification
Incidence, severity, and type of postoperative complications, graded according to the Clavien-Dindo classification. Between-group comparison of complication rates will be performed.
Time frame: Through 12 months after surgery (cumulative at postoperative day 30, 90, 180, and 360)
Plan to share: No — Individual participant data will not be shared. Study results will be disseminated through publication in peer-reviewed journals and conference presentations.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Shanghai East Hospital