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

D

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

Trial contacts and locations

1

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Central trial contact

Gautier Müllhaupt, MD; Dominik Abt, MD

Data sourced from clinicaltrials.gov

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