Database for the Assessment of Efficacy and Safety of BPH Treatment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Database for the Assessment of Efficacy and Safety of BPH Treatment

Conditions
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Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia

Intervention / Treatment
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* Procedure: PAE
* Procedure: TURP
* Procedure: Other


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PAE<br>Men with BPH - LUTS BPE who have opted for PAE and have consented to take part in the Register Study. | Procedure: PAE<br>* Prostatic artery embolization<br>|
| TURP<br>Men with BPH - LUTS BPE who have opted for TURP and have consented to take part in the Register Study. | Procedure: TURP<br>* Transurethral resection of the prostate<br>|
| Other<br>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. | Procedure: Other<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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)) | baseline to 1 year | 
| Changes of free urinary flow rate | Measurement of urinary stream (mL/s) by urinary flow rate measurement | baseline to 1 year | 
| Changes of post void residual urine | Measurement of post void residual urine (mL) by transabdominal ultrasound | baseline to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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)) | 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)) | 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)) | 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)) | baseline to 2 years | 
| 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)) | baseline to 5 years | 
| Changes of free urinary flow rate | Measurement of urinary stream (mL/s) by urinary flow rate measurement | baseline to 6 weeks | 
| Changes of free urinary flow rate | Measurement of urinary stream (mL/s) by urinary flow rate measurement | baseline to 12 weeks | 
| Changes of free urinary flow rate | Measurement of urinary stream (mL/s) by urinary flow rate measurement | baseline to 6 months | 
| Changes of free urinary flow rate | Measurement of urinary stream (mL/s) by urinary flow rate measurement | baseline to 2 years | 
| Changes of free urinary flow rate | Measurement of urinary stream (mL/s) by urinary flow rate measurement | baseline to 5 years | 
| Changes of post void residual urine | Measurement of post void residual urine (mL) by transabdominal ultrasound | baseline to 6 weeks | 
| Changes of post void residual urine | Measurement of post void residual urine (mL) by transabdominal ultrasound | baseline to 12 weeks | 
| Changes of post void residual urine | Measurement of post void residual urine (mL) by transabdominal ultrasound | baseline to 6 months | 
| Changes of post void residual urine | Measurement of post void residual urine (mL) by transabdominal ultrasound | baseline to 2 years | 
| Changes of post void residual urine | Measurement of post void residual urine (mL) by transabdominal ultrasound | baseline to 5 years | 
| Rate of local reinterventions | Assessment of number and type of reinterventions for prostate and bladder problems | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 5 years after intervention | 
| Urodynamic changes | Results of pressure flow studies if assessed for clinical reasons during the study period | during 5 year study period | 
| Change of prostate size | Measurement of prostate size (using MRI or ultrasound) in mL | 6 weeks after intervention | 
| Change of prostate size | Measurement of prostate size (using MRI or ultrasound) in mL | 12 weeks after intervention | 
| Change of prostate size | Measurement of prostate size (using MRI or ultrasound) in mL | 6 moths after intervention | 
| Change of prostate size | Measurement of prostate size (using MRI or ultrasound) in mL | 1 year after intervention | 
| Change of prostate size | Measurement of prostate size (using MRI or ultrasound) in mL | 2 years after intervention | 
| Change of prostate size | Measurement of prostate size (using MRI or ultrasound) in mL | 5 years after intervention | 
| PSA | Changes of Prostate Specific Antigen (PSA, ng/mL) | 6 weeks after intervention | 
| PSA | Changes of Prostate Specific Antigen (PSA, ng/mL) | 12 weeks after intervention | 
| PSA | Changes of Prostate Specific Antigen (PSA, ng/mL) | 6 moths after intervention | 
| PSA | Changes of Prostate Specific Antigen (PSA, ng/mL) | 1 year after intervention | 
| PSA | Changes of Prostate Specific Antigen (PSA, ng/mL) | 2 years after intervention | 
| PSA | Changes of Prostate Specific Antigen (PSA, ng/mL) | 5 years after intervention | 
| Assessment of erectile function | Assessment of IIEF-5 questionnaire | 6 weeks after intervention | 
| Assessment of erectile function | Assessment of IIEF-5 questionnaire | 12 weeks after intervention | 
| Assessment of erectile function | Assessment of IIEF-5 questionnaire | 6 moths after intervention | 
| Assessment of erectile function | Assessment of IIEF-5 questionnaire | 1 year after intervention | 
| Assessment of erectile function | Assessment of IIEF-5 questionnaire | 2 years after intervention | 
| Assessment of erectile function | Assessment of IIEF-5 questionnaire | 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)) | 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)) | 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)) | 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)) | 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)) | 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)) | baseline to 5 years | 
| Ejaculatory function | Assessment of ejaculatory function according to CTCAE | 6 weeks after intervention | 
| Ejaculatory function | Assessment of ejaculatory function according to CTCAE | 12 weeks after intervention | 
| Ejaculatory function | Assessment of ejaculatory function according to CTCAE | 6 moths after intervention | 
| Ejaculatory function | Assessment of ejaculatory function according to CTCAE | 1 year after intervention | 
| Ejaculatory function | Assessment of ejaculatory function according to CTCAE | 2 years after intervention | 
| Ejaculatory function | Assessment of ejaculatory function according to CTCAE | 5 years after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostatic Artery Embolization, Transurethral Prostate Resection, Transurethral Electroresection of Prostate, Contact Laser Ablation of Prostate, Laser Enucleation of Prostate, Open prostatectomy