Database for the Assessment of Efficacy and Safety of BPH Treatment

Benign Prostatic Hyperplasia Clinical Trial

— KSSG-BPH-REG  

Official title:

Database for the Assessment of Efficacy and Safety of BPH Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03521648
• Other study ID #: CTU P-17/006
• Status: Recruiting
• Start date: July 7, 2017
• Est. completion date: December 1, 2027

Study information

• Verified date: January 2021
• Source: Cantonal Hospital of St. Gallen
• Contact: Dominik Abt, MD
• Phone: +41 71 494 14 16
• Email: dominik.abt[@]kssg.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 1, 2027
• Est. primary completion date: December 1, 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

Procedure:
• PAE
Prostatic artery embolization
• TURP
Transurethral resection of the prostate
• 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

Locations

Country	Name	City	State
Switzerland	St. Gallen Cantonal Hospital	St. Gallen	Saint Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Dominik Abt

Country where clinical trial is conducted

Switzerland, 

Outcome

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