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).
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.
Study Type
OBSERVATIONAL
Enrollment
500
Prostatic artery embolization
Transurethral resection of the prostate
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
St. Gallen Cantonal Hospital
Sankt Gallen, Canton of St. Gallen, Switzerland
RECRUITINGReduction of Lower Urinary Tract Symptoms
Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))
Time frame: baseline to 1 year
Changes of free urinary flow rate
Measurement of urinary stream (mL/s) by urinary flow rate measurement
Time frame: baseline to 1 year
Changes of post void residual urine
Measurement of post void residual urine (mL) by transabdominal ultrasound
Time frame: baseline to 1 year
Reduction of Lower Urinary Tract Symptoms
Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))
Time frame: baseline to 6 weeks
Reduction of Lower Urinary Tract Symptoms
Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))
Time frame: baseline to 12 weeks
Reduction of Lower Urinary Tract Symptoms
Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))
Time frame: baseline to 6 months
Reduction of Lower Urinary Tract Symptoms
Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))
Time frame: baseline to 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Reduction of Lower Urinary Tract Symptoms
Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))
Time frame: baseline to 5 years
Changes of free urinary flow rate
Measurement of urinary stream (mL/s) by urinary flow rate measurement
Time frame: baseline to 6 weeks
Changes of free urinary flow rate
Measurement of urinary stream (mL/s) by urinary flow rate measurement
Time frame: baseline to 12 weeks
Changes of free urinary flow rate
Measurement of urinary stream (mL/s) by urinary flow rate measurement
Time frame: baseline to 6 months
Changes of free urinary flow rate
Measurement of urinary stream (mL/s) by urinary flow rate measurement
Time frame: baseline to 2 years
Changes of free urinary flow rate
Measurement of urinary stream (mL/s) by urinary flow rate measurement
Time frame: baseline to 5 years
Changes of post void residual urine
Measurement of post void residual urine (mL) by transabdominal ultrasound
Time frame: baseline to 6 weeks
Changes of post void residual urine
Measurement of post void residual urine (mL) by transabdominal ultrasound
Time frame: baseline to 12 weeks
Changes of post void residual urine
Measurement of post void residual urine (mL) by transabdominal ultrasound
Time frame: baseline to 6 months
Changes of post void residual urine
Measurement of post void residual urine (mL) by transabdominal ultrasound
Time frame: baseline to 2 years
Changes of post void residual urine
Measurement of post void residual urine (mL) by transabdominal ultrasound
Time frame: baseline to 5 years
Rate of local reinterventions
Assessment of number and type of reinterventions for prostate and bladder problems
Time frame: during 5 year study period
Rate of local medical treatment for BPH-LUTS
Assessment of number and type of medical treatments for prostate and bladder problems
Time frame: during 5 year study period
Adverse Events
Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE
Time frame: 6 weeks after intervention
Adverse Events
Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE
Time frame: 12 weeks after intervention
Adverse Events
Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE
Time frame: 6 months after intervention
Adverse Events
Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE
Time frame: 1 year after intervention
Adverse Events
Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE
Time frame: 2 years after intervention
Adverse Events
Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE
Time frame: 5 years after intervention
Urodynamic changes
Results of pressure flow studies if assessed for clinical reasons during the study period
Time frame: during 5 year study period
Change of prostate size
Measurement of prostate size (using MRI or ultrasound) in mL
Time frame: 6 weeks after intervention
Change of prostate size
Measurement of prostate size (using MRI or ultrasound) in mL
Time frame: 12 weeks after intervention
Change of prostate size
Measurement of prostate size (using MRI or ultrasound) in mL
Time frame: 6 moths after intervention
Change of prostate size
Measurement of prostate size (using MRI or ultrasound) in mL
Time frame: 1 year after intervention
Change of prostate size
Measurement of prostate size (using MRI or ultrasound) in mL
Time frame: 2 years after intervention
Change of prostate size
Measurement of prostate size (using MRI or ultrasound) in mL
Time frame: 5 years after intervention
PSA
Changes of Prostate Specific Antigen (PSA, ng/mL)
Time frame: 6 weeks after intervention
PSA
Changes of Prostate Specific Antigen (PSA, ng/mL)
Time frame: 12 weeks after intervention
PSA
Changes of Prostate Specific Antigen (PSA, ng/mL)
Time frame: 6 moths after intervention
PSA
Changes of Prostate Specific Antigen (PSA, ng/mL)
Time frame: 1 year after intervention
PSA
Changes of Prostate Specific Antigen (PSA, ng/mL)
Time frame: 2 years after intervention
PSA
Changes of Prostate Specific Antigen (PSA, ng/mL)
Time frame: 5 years after intervention
Assessment of erectile function
Assessment of IIEF-5 questionnaire
Time frame: 6 weeks after intervention
Assessment of erectile function
Assessment of IIEF-5 questionnaire
Time frame: 12 weeks after intervention
Assessment of erectile function
Assessment of IIEF-5 questionnaire
Time frame: 6 moths after intervention
Assessment of erectile function
Assessment of IIEF-5 questionnaire
Time frame: 1 year after intervention
Assessment of erectile function
Assessment of IIEF-5 questionnaire
Time frame: 2 years after intervention
Assessment of erectile function
Assessment of IIEF-5 questionnaire
Time frame: 5 years after intervention
Reduction of Prostate symptoms
Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))
Time frame: baseline to 6 weeks
Reduction of Prostate symptoms
Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))
Time frame: baseline to 12 weeks
Reduction of Prostate symptoms
Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))
Time frame: baseline to 6 moths
Reduction of Prostate symptoms
Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))
Time frame: baseline to 1 year
Reduction of Prostate symptoms
Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))
Time frame: baseline to 2 years
Reduction of Prostate symptoms
Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))
Time frame: baseline to 5 years
Ejaculatory function
Assessment of ejaculatory function according to CTCAE
Time frame: 6 weeks after intervention
Ejaculatory function
Assessment of ejaculatory function according to CTCAE
Time frame: 12 weeks after intervention
Ejaculatory function
Assessment of ejaculatory function according to CTCAE
Time frame: 6 moths after intervention
Ejaculatory function
Assessment of ejaculatory function according to CTCAE
Time frame: 1 year after intervention
Ejaculatory function
Assessment of ejaculatory function according to CTCAE
Time frame: 2 years after intervention
Ejaculatory function
Assessment of ejaculatory function according to CTCAE
Time frame: 5 years after intervention