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The Safety and Efficiency of Transurethral Columnar Balloon Dilation of Prostate for BPH: a randomized, sham-controlled, multicenter clinical trial

The Safety and Efficiency of Transurethral Columnar Balloon Dilation of Prostate for BPH: a randomized, sham-controlled, multicenter clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017344
Enrollment
Unknown
Registered
2018-07-25
Start date
2018-08-01
Completion date
Unknown
Last updated
2019-08-27

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

Conditions

Benign prostatic hyperplasia

Interventions

Sponsors

Beijing Chao-Yang Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: (1) male patients aged 50-80 years with benign prostatic hyperplasia (BPH) who have failed conservative treatment; (2) patients with prostate volume of 30~120ml; (3) international prostate symptom score (IPSS) >=10; (4) Urodynamic study indicates bladder outlet obstruction (BOO); (5) the maximum urine flow rate (Qmax) is less than 15ml/s; (6) prostate-specific antigen (PSA) < 10ng/mL (4-10ng/mL need to exclude prostate cancer); (7) subject is informed and voluntarily signs the informed consent.

Exclusion criteria

Exclusion criteria: (1) patients with abnormal cardiopulmonary function, abnormal coagulation function or other systemic diseases, who cannot tolerate anesthesia and surgery; (2) patients with obvious hyperplasia of the middle prostate gland and IPP>2cm confirmed by ultrasonography; (3) patients with prostate cancer or urinary malignant tumors; (4) patients with a history of prostate and urethral surgery; (5) dysuria that is not related to BPH; (6) patients with severe urethral stricture who cannot complete the operation; (7) patients with neurogenic bladder; (8) acute urinary tract infection, acute prostatitis or other infections; (9) high allergic constitution and allergy to the products of this clinical study; (10) participating in other clinical trials within 3 months; (11) other patients not suitable for the test considered by clinicians.

Design outcomes

Primary

MeasureTime frame
International Prostate Symptom Score;

Secondary

MeasureTime frame
Urodynamic study;QOL;VAS;Urine pad test;Bladder flushing time;Indwelling catheter time;Postoperative hospitalization time;

Countries

China

Contacts

Public ContactNianzeng Xing

Beijing Chao-Yang Hospital, Capital Medical University

363210201@qq.com+86 13910902193

Outcome results

None listed

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