Database for the Assessment of Efficacy and Safety of BPH Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PAE, TURP, Other.
- Who it may be relevant to
- Registry conditions: Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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).
Detailed 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.
Interventions
- Procedure PAE
Prostatic artery embolization - Procedure TURP
Transurethral resection of the prostate - Procedure Other
Other surgical procedures for BPH treatment including holmium laser enucleation of the prostate, open prostatectomy, thulium laser vaporization, resection or enucleation, transurethral incision of the prostate
Primary outcome measures
- Reduction of Lower Urinary Tract Symptoms [Time frame: baseline to 1 year]
- Changes of free urinary flow rate [Time frame: baseline to 1 year]
- Changes of post void residual urine [Time frame: baseline to 1 year]
Secondary outcome measures (12)
- Reduction of Lower Urinary Tract Symptoms [Time frame: baseline to 6 weeks]
- Reduction of Lower Urinary Tract Symptoms [Time frame: baseline to 12 weeks]
- Reduction of Lower Urinary Tract Symptoms [Time frame: baseline to 6 months]
- Reduction of Lower Urinary Tract Symptoms [Time frame: baseline to 2 years]
- Reduction of Lower Urinary Tract Symptoms [Time frame: baseline to 5 years]
- Changes of free urinary flow rate [Time frame: baseline to 6 weeks]
- Changes of free urinary flow rate [Time frame: baseline to 12 weeks]
- Changes of free urinary flow rate [Time frame: baseline to 6 months]
- Changes of free urinary flow rate [Time frame: baseline to 2 years]
- Changes of free urinary flow rate [Time frame: baseline to 5 years]
- Changes of post void residual urine [Time frame: baseline to 6 weeks]
- Changes of post void residual urine [Time frame: baseline to 12 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Switzerland · 1 center
- St. Gallen Cantonal Hospital — Sankt Gallen
Identifiers
NCT: NCT03521648 · CTU P-17/006