Clinical trial NCT03521648: Database for the Assessment of Efficacy and Safety of BPH Treatment
Official title: Database for the Assessment of Efficacy and Safety of BPH Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lower Urinary Tract Symptoms
Benign Prostatic Hyperplasia
Keywords: Prostatic Artery Embolization
Transurethral Prostate Resection
Transurethral Electroresection of Prostate
Contact Laser Ablation of Prostate
Laser Enucleation of Prostate
Open prostatectomy
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 500
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients treated for BPH / LUTS / prostatic obstruction at the urological department of KSSG

Brief summary: 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.

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.

Primary outcomes:
measure: Reduction of Lower Urinary Tract Symptoms
timeFrame: baseline to 1 year
measure: Changes of free urinary flow rate
timeFrame: baseline to 1 year
measure: Changes of post void residual urine
timeFrame: baseline to 1 year
Secondary outcomes:
measure: Reduction of Lower Urinary Tract Symptoms
timeFrame: baseline to 6 weeks
measure: Reduction of Lower Urinary Tract Symptoms
timeFrame: baseline to 12 weeks
measure: Reduction of Lower Urinary Tract Symptoms
timeFrame: baseline to 6 months
measure: Reduction of Lower Urinary Tract Symptoms
timeFrame: baseline to 2 years
measure: Reduction of Lower Urinary Tract Symptoms
timeFrame: baseline to 5 years
measure: Changes of free urinary flow rate
timeFrame: baseline to 6 weeks
measure: Changes of free urinary flow rate
timeFrame: baseline to 12 weeks
measure: Changes of free urinary flow rate
timeFrame: baseline to 6 months
measure: Changes of free urinary flow rate
timeFrame: baseline to 2 years
measure: Changes of free urinary flow rate
timeFrame: baseline to 5 years
measure: Changes of post void residual urine
timeFrame: baseline to 6 weeks
measure: Changes of post void residual urine
timeFrame: baseline to 12 weeks
measure: Changes of post void residual urine
timeFrame: baseline to 6 months
measure: Changes of post void residual urine
timeFrame: baseline to 2 years
measure: Changes of post void residual urine
timeFrame: baseline to 5 years
measure: Rate of local reinterventions
timeFrame: during 5 year study period
measure: Rate of local medical treatment for BPH-LUTS
timeFrame: during 5 year study period
measure: Adverse Events
timeFrame: 6 weeks after intervention
measure: Adverse Events
timeFrame: 12 weeks after intervention
measure: Adverse Events
timeFrame: 6 months after intervention
measure: Adverse Events
timeFrame: 1 year after intervention
measure: Adverse Events
timeFrame: 2 years after intervention
measure: Adverse Events
timeFrame: 5 years after intervention
measure: Urodynamic changes
timeFrame: during 5 year study period
measure: Change of prostate size
timeFrame: 6 weeks after intervention
measure: Change of prostate size
timeFrame: 12 weeks after intervention
measure: Change of prostate size
timeFrame: 6 moths after intervention
measure: Change of prostate size
timeFrame: 1 year after intervention
measure: Change of prostate size
timeFrame: 2 years after intervention
measure: Change of prostate size
timeFrame: 5 years after intervention
measure: PSA
timeFrame: 6 weeks after intervention
measure: PSA
timeFrame: 12 weeks after intervention
measure: PSA
timeFrame: 6 moths after intervention
measure: PSA
timeFrame: 1 year after intervention
measure: PSA
timeFrame: 2 years after intervention
measure: PSA
timeFrame: 5 years after intervention
measure: Assessment of erectile function
timeFrame: 6 weeks after intervention
measure: Assessment of erectile function
timeFrame: 12 weeks after intervention
measure: Assessment of erectile function
timeFrame: 6 moths after intervention
measure: Assessment of erectile function
timeFrame: 1 year after intervention
measure: Assessment of erectile function
timeFrame: 2 years after intervention
measure: Assessment of erectile function
timeFrame: 5 years after intervention
measure: Reduction of Prostate symptoms
timeFrame: baseline to 6 weeks
measure: Reduction of Prostate symptoms
timeFrame: baseline to 12 weeks
measure: Reduction of Prostate symptoms
timeFrame: baseline to 6 moths
measure: Reduction of Prostate symptoms
timeFrame: baseline to 1 year
measure: Reduction of Prostate symptoms
timeFrame: baseline to 2 years
measure: Reduction of Prostate symptoms
timeFrame: baseline to 5 years
measure: Ejaculatory function
timeFrame: 6 weeks after intervention
measure: Ejaculatory function
timeFrame: 12 weeks after intervention
measure: Ejaculatory function
timeFrame: 6 moths after intervention
measure: Ejaculatory function
timeFrame: 1 year after intervention
measure: Ejaculatory function
timeFrame: 2 years after intervention
measure: Ejaculatory function
timeFrame: 5 years after intervention
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: St. Gallen Cantonal Hospital
state: Saint Gallen
Study officials:
References: