Database for the Assessment of Efficacy and Safety of BPH Treatment (KSSG-BPH-REG)

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).

Study Overview

• Status: Recruiting
• Conditions: Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia
• Intervention / Treatment: Procedure: PAE; Procedure: TURP; Procedure: Other

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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Dominik Abt, MD; Phone Number: +41 71 494 14 16; Email: dominik.abt@kssg.ch
• Study Contact Backup: Name: Gautier Müllhaupt, MD; Phone Number: +41 71 494 14 16; Email: Gautier.muellhaupt@kssg.ch

Study Locations

• Switzerland
  • Saint Gallen
    • St. Gallen, Saint Gallen, Switzerland, 9007
      • Recruiting
      • St. Gallen Cantonal Hospital
      • Contact: Dominik Abt, MD; Phone Number: +41714941416; Email: dominik.abt@kssg.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

All patients treated for BPH / LUTS / prostatic obstruction at the urological department of KSSG

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dominik Abt

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2017
• Primary Completion (Anticipated): December 1, 2027
• Study Completion (Anticipated): December 1, 2027

Study Registration Dates

• First Submitted: April 29, 2018
• First Submitted That Met QC Criteria: April 29, 2018
• First Posted (Actual): May 11, 2018

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Prostatic Artery Embolization; Open prostatectomy; Transurethral Prostate Resection; Transurethral Electroresection of Prostate; Contact Laser Ablation of Prostate; Laser Enucleation of Prostate
• Additional Relevant MeSH Terms: Pathologic Processes; Urological Manifestations; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms
• Other Study ID Numbers: CTU P-17/006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Requests for an anonymized, full data set of physician-level data and statistical code will be considered if the proposed use aligns with public good purposes, does not conflict with other requests, or planned use by the trial steering committee and is contingent on approval from the local ethics committee (EKOS). Requests can be addressed to the corresponding author.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No