This single-center, single-arm, prospective clinical study aims to preliminarily evaluate the safety and effectiveness of ultra-minimally invasive prostatic dilation using a prostate dilation catheter under real-time transrectal ultrasound (TRUS) guidance in male patients with significant bladder outlet obstruction secondary to benign prostatic hyperplasia (BPH).
A total of 5 eligible male subjects aged 40 to 80 years with symptomatic BPH, International Prostate Symptom Score (IPSS) ≥13, maximum urinary flow rate (Qmax) of 5-10 mL/s, prostate volume \<30 mL measured by TRUS, and evident bladder outlet obstruction will be enrolled. All subjects will undergo prostatic balloon dilation with the study device under real-time TRUS guidance. Follow-up assessments will be conducted at 1, 3, and 6 months after treatment.
The primary effectiveness endpoint is the change in IPSS from baseline at 1, 3, and 6 months. The primary safety endpoints include bladder neck contracture, retrograde ejaculation, device-related severe urinary retention persisting for more than 14 days after healing, new-onset stress urinary incontinence, device-related bleeding requiring transfusion, and device-related urethral or prostatic capsular rupture requiring surgical intervention.
Secondary endpoints include responder rates based on different thresholds of IPSS improvement (≥30%, ≥40%, and ≥50%), changes in Qmax, and changes in visual analogue scale (VAS) scores. Exploratory endpoints include changes in postvoid residual urine volume (PVR) and sexual function assessed by the International Index of Erectile Function (IIEF-5) and the Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD).
This exploratory study is intended to provide preliminary clinical evidence supporting the safety and potential clinical benefit of TRUS-guided ultra-minimally invasive prostatic dilation for BPH-related obstruction and to inform future larger-scale clinical studies.
Male subjects aged 40 to 80 years with symptomatic benign prostatic hyperplasia (BPH) and obvious bladder outlet obstruction.
Subjects with normal sexual life and a sexual partner, and with intact sexual function.
International Prostate Symptom Score (IPSS) ≥ 13.
Maximum urinary flow rate (Qmax) between 5 and 10 mL/s, with a minimum voided volume ≥ 150 mL.
Subjects who are unable or unwilling to sign the informed consent form (ICF) and/or comply with all follow-up requirements.
Subjects who are unwilling to abstain from sexual activity or use protective sexual behavior within 90 days after treatment.
Prostate-specific antigen (PSA) ≥ 10 ng/mL, unless prostate cancer has been excluded by biopsy.
Confirmed or suspected prostate or bladder malignancy.
Single group
Prostate Dilation Catheter
DeviceThe intervention consists of ultra-minimally invasive dilation of the prostatic urethra using a dedicated prostate dilation catheter under real-time transrectal ultrasound guidance. The treatment is designed to relieve bladder outlet obstruction caused by benign prostatic hyperplasia while preserving urinary and sexual function.
Change in International Prostate Symptom Score from baseline to 3 months after treatment
The International Prostate Symptom Score, or IPSS, will be used to evaluate lower urinary tract symptoms associated with benign prostatic hyperplasia. The score ranges from 0 to 35, with higher scores indicating more severe symptoms. The change in IPSS from baseline to 3 months after treatment will be assessed.
Change in maximum urinary flow rate from baseline to 3 months after treatment
Maximum urinary flow rate, or Qmax, will be measured by uroflowmetry. The change in Qmax from baseline to 3 months after treatment will be assessed. A higher Qmax indicates improved urinary flow.
Incidence of treatment-related adverse events
The incidence, severity, and relationship to the study procedure or device of adverse events will be recorded throughout the study. Adverse events may include hematuria, urinary tract infection, urinary retention, pain, dysuria, urethral injury, or other procedure-related complications.
Change in quality of life score from baseline to 3 months after treatment
The quality of life score related to urinary symptoms will be assessed using the quality of life question of the International Prostate Symptom Score. The score ranges from 0 to 6, with higher scores indicating worse quality of life. The change from baseline to 3 months after treatment will be evaluated.
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Qing Yuan
Lead sponsor
Chinese PLA General Hospital
Sponsor institution
