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Clinical Study for Prostatic Arterial Embolization in the Treatment of Benign Prostatic Hyperplasia

Clinical Study for Prostatic Arterial Embolization in the Treatment of Benign Prostatic Hyperplasia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000028819
Enrollment
Unknown
Registered
2020-01-04
Start date
2020-01-01
Completion date
Unknown
Last updated
2020-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

benign prostatic hyperplasia

Interventions

Experimental group:PAE with bleomycin-eluting 30 - 60 um microspheres
Control group:PAE combined with 40-120um Embosphere and PVA-100

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Patients older than 50 years of age with a diagnosis of severe lower urinary tract symptoms (International Prostate Symptom Score [IPSS]>8, quality of life [QoL] score>3, peak urinary flow rate [Qmax]6 months) and prostate volume (PV) greater than 50 mL. Prostate biopsy was performed in men with prostatespecific antigen (PSA) levels greater than 4.0 ng/mL to exclude malignancy; Not suitable or unwilling to accept surgical treatment due to comorbidities.

Exclusion criteria

Exclusion criteria: Patients who have underwent PAE or prostatectomypriviously; active prostatitis or urinary tract infection; neurogenic bladder or detrusor failure; prostate malignancy; large (>5 cm) bladder diverticula; chronic renal failure; urethral stricture; coagulopathies; allergic to iodine contrast medium; with mental disorders; can not complete postoperative follow-up; and the presence of a cardiac pacemaker, a nerve stimulator, or other metal implants.

Design outcomes

Primary

MeasureTime frame
International Prostate Symptom (IPSS) Score;

Secondary

MeasureTime frame
prostate volume;post-void urine residual volume;quality of life(QoL);prostate-specific antigen (PSA);prostate-specific antigen (PSA);

Countries

China

Contacts

Public ContactWang Mao-Qiang

Chinese PLA General Hospital

wangmq@vip.sina.com+86 13910531926

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026