Database for the Assessment of Efficacy and Safety of BPH Treatment (KSSG-BPH-REG)

Dominik Abt

Status: Enrolling

Conditions: Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia

Treatments: Procedure: Other; Procedure: PAE; Procedure: TURP

Study type: Observational

Funder types: Other

Identifiers

NCT03521648

CTU P-17/006

Details and patient eligibility

About

This registry study aims to collect data on efficacy and safety of different treatments of benign prostatic enlargement (BPE) and lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH-LUTS).

Full description

This registry study aims to collect data on efficacy and safety of different treatments of benign prostatic enlargement (BPE) and lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH-LUTS).

Clinical, patient reported and imaging data that are assessed in clinical routine will be prospectively collected. All patients that are treated for BPE / BPH-LUTS at our institution will be included if they provide written informed consent.

This registry enables us to compare novel treatment option (e.g. prostatic artery embolization; PAE) to established interventions (e.g., TURP, HoLEP, open prostatectomy, ThuLEP, Thulium laser vaporization, TUIP) regarding safety and efficacy.

Enrollment: 500 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients treated for BPH / LUTS / prostatic obstruction at the urological department of KSSG
• Patient age ≥ 18 years
• Informed consent provided

Exclusion criteria

-Cognitive impairment not allowing Informed Consent or adequate data assessment.

Trial design

500 participants in 3 patient groups

PAE

Description:

Men with BPH - LUTS BPE who have opted for PAE and have consented to take part in the Register Study.

Treatment:

Procedure: PAE

TURP

Description:

Men with BPH - LUTS BPE who have opted for TURP and have consented to take part in the Register Study.

Treatment:

Procedure: TURP

Other

Description:

Men with BPH - LUTS BPE who have opted for other treatment options (e.g., holmium laser enucleation of the prostate, open prostatectomy, thulium laser vaporization, resection or enucleation, transurethral incision of the prostate) and have consented to take part in the Register Study.

Treatment:

Procedure: Other