Actively Recruiting
Database for the Assessment of Efficacy and Safety of BPH Treatment
Led by Dominik Abt · Updated on 2021-01-26
500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to collect data on the effectiveness and safety of various treatments for benign prostatic enlargement (BPE) and the lower urinary tract symptoms related to benign prostatic hyperplasia (BPH-LUTS). The study includes men who receive treatment for these conditions at the participating institution and provides insights into different treatment options including newer methods compared to established surgical procedures. Participants receive one of several treatment options such as prostatic artery embolization (PAE), transurethral resection of the prostate (TURP), or other surgical procedures like holmium laser enucleation, open prostatectomy, and thulium laser vaporization. The study collects clinical, patient-reported, and imaging data prospectively as part of routine clinical care, enabling comparison of safety and efficacy among these treatment approaches. During the study, researchers will monitor participants over time, assessing changes in urinary symptoms, urinary flow rates, and residual urine volume from baseline up to one year and beyond. Assessments also include follow-up for adverse events, prostate size changes, erectile and ejaculatory function, and other outcomes over a period of up to five years. Participants contribute data through routine clinical visits, imaging, and questionnaires, helping to evaluate long-term treatment results and safety.
CONDITIONS
Brief Title
Database for the Assessment of Efficacy and Safety of BPH Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- All patients treated for BPH, lower urinary tract symptoms, or prostatic obstruction at the urological department
- Male patients aged 18 years or older
- Written informed consent provided
You will not qualify if you...
- Cognitive impairment that prevents providing informed consent or adequate data collection assessment
- Female patients (gender restriction to male only due to condition studied)
- Patients who do not provide informed consent or are unable to participate in data collection adequately
- Patients not treated for BPH or related urinary symptoms at the study institution
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Varies depending on treatment and recovery
Participants undergo their chosen treatment for benign prostatic hyperplasia, which may include prostatic artery embolization, transurethral resection of the prostate, or other surgical procedures.
1 treatment visit (in-person)
Duration - Up to 5 years
Participants are monitored over multiple years to assess the efficacy and safety of their treatment through clinical assessments, patient-reported outcomes, and imaging data collected as part of routine care.
Multiple follow-up visits over 5 years
Trial Site Locations
Total: 1 location
1
St. Gallen Cantonal Hospital
Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
Actively Recruiting
Research Team
D
Dominik Abt, MD
G
Gautier Müllhaupt, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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