Benign Prostatic Hyperplasia
Conditions
Interventions
Experimental group:paclitaxel-coated prostatic balloon dilation catheter system
Control group:None (perform cystoscopy to simulate the treatment procedure)
Sponsors
Beijing Friendship Hospital, Capital Medical University
Eligibility
Sex/Gender
Male
Age
45 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male subjects with lower urinary tract symptoms aged 45 years and above; 2. International Prostate Symptom Score (IPSS) >=13; 3. Maximum urinary flow rate (Qmax) >=5mL/s and =150mL); 4. Magnetic resonance (MRI) or transrectal ultrasound (TRUS) determination of prostate volume >=20mL and =32mm and <=55mm as measured by MRI or TRUS; 6. Subjects or their legal representatives are able to understand the purpose of the study, demonstrate adequate compliance with the study protocol, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Subjects planning to conceive during the study period; 2.Presence of an artificial urinary sphincter or stent in the urethra or prostate; 3.Subjects with a previously implanted penile prosthesis; 4.Prior invasive prostate treatments (e.g., radiofrequency ablation, balloon dilation, microwave therapy, laser therapy, transurethral resection, prostatic urethral stents, or prostate lift procedures); 5.Total prostate-specific antigen (tPSA) >=10 ng/mL, unless prostate cancer has been ruled out by biopsy; 6.Diagnosis of malignancy prior to enrollment; 7.Uncontrolled acute urinary or genitourinary infections; 8.History of pelvic radiation therapy or radical pelvic surgery; 9.Neurogenic bladder or neurological disorders affecting bladder function, sphincter function, or detrusor function, as assessed by the investigator; 10.Urethral stricture or bladder neck contracture that may hinder device insertion; 11.Urinary incontinence due to sphincter dysfunction or severe urgency urinary incontinence; 12.History of rectal surgery (except for hemorrhoidectomy) or rectal diseases that may affect the study treatment or outcome assessment; 13.Use of a-blockers (e.g., tamsulosin, terazosin, doxazosin), phosphodiesterase-5 (PDE5) inhibitors (e.g., tadalafil), muscarinic receptor antagonists (e.g., oxybutynin, tolterodine, solifenacin), or ß3 receptor agonists (e.g., mirabegron) within 2 weeks before enrollment; 14.Use of type II 5-alpha reductase inhibitors (e.g., finasteride) within 3 months before enrollment; 15.Use of non-selective 5-alpha reductase inhibitors (e.g., dutasteride) within 6 months before enrollment; 16.Use of antiplatelet agents (e.g., aspirin, clopidogrel) or anticoagulants (e.g., apixaban, fondaparinux, rivaroxaban, edoxaban) within 7 days before treatment or planned use within 5 days after the procedure; 17.History of hypersensitivity to paclitaxel or structurally related compounds, or concurrent use of medications that may interact adversely with paclitaxel or its related compounds; 18.Immunosuppressive conditions (e.g., HIV infection, organ transplant recipients on immunosuppressive therapy); 19.History of spontaneous urinary retention within 6 months prior to enrollment; 20.Post-void residual urine volume >300 mL or requirement for bladder drainage via catheterization; 21.Current diagnosis of bladder or prostatic urethral calculi; 22.Diagnosis of a clinically significant or unstable medical condition within the past 3 months (e.g., cardiovascular, pulmonary, renal, hepatic, bleeding disorders, or metabolic disorders), such as severe heart failure, unstable angina, myocardial infarction, transient ischemic attack, stroke, chronic obstructive pulmonary disease, renal insufficiency, hepatic dysfunction, uncorrectable bleeding disorders, severe coagulopathy, or severe anemia, which may affect study outcomes or pose a risk to the subject as determined by the investigator; 23.Any cognitive impairment that may hinder communication with the investigator or completion of study questionnaires; 24.Life expectancy of less than 1 year; 25. Concurrent participation in another clinical trial, participation in a drug clinical trial within the past 3 months, or participation in a medical device clinical trial within the past 30 days; 26. Any other condition deemed unsuitable for clinical trial participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate of the International Prostate Symptom Score (IPSS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the International Prostate Symptom Score (IPSS);Maximum Urine Flow Rate (Qmax);Post-Void Residual Volume (PVR);International Index of Erectile Function (IIEF-5);Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD);Quality of Life (QoL) Score;Pain Score;Device Operability Evaluation; | — |
Countries
China
Contacts
Public ContactJing Xiao
Beijing Friendship Hospital, Capital Medical University
Outcome results
None listed