Database for the Assessment of Efficacy and Safety of BPH Treatment

Recruiting

• Conditions: Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms

• Registration Number: NCT03521648
• Lead Sponsor: Dominik Abt

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.

Study Timeline

• Study Start: 2017-07-07
• Study First Submitted: 2018-04-29
• Study First Submitted QC: 2018-04-29
• Study First Posted: 2018-05-11
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-25
• Last Update Posted: 2021-01-26
• Primary Completion: 2027-12-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes of free urinary flow rate	baseline to 1 year	Measurement of urinary stream (mL/s) by urinary flow rate measurement
Changes of post void residual urine	baseline to 1 year	Measurement of post void residual urine (mL) by transabdominal ultrasound
Reduction of Lower Urinary Tract Symptoms	baseline to 1 year	Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))

Secondary Outcome Measures

Name	Time	Method
Adverse Events	5 years after intervention	Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE
Changes of free urinary flow rate	baseline to 5 years	Measurement of urinary stream (mL/s) by urinary flow rate measurement
Reduction of Lower Urinary Tract Symptoms	baseline to 5 years	Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))
Changes of post void residual urine	baseline to 5 years	Measurement of post void residual urine (mL) by transabdominal ultrasound
Rate of local reinterventions	during 5 year study period	Assessment of number and type of reinterventions for prostate and bladder problems
Rate of local medical treatment for BPH-LUTS	during 5 year study period	Assessment of number and type of medical treatments for prostate and bladder problems
Urodynamic changes	during 5 year study period	Results of pressure flow studies if assessed for clinical reasons during the study period
Reduction of Prostate symptoms	baseline to 5 years	Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))
Assessment of erectile function	5 years after intervention	Assessment of IIEF-5 questionnaire
Ejaculatory function	5 years after intervention	Assessment of ejaculatory function according to CTCAE
Change of prostate size	5 years after intervention	Measurement of prostate size (using MRI or ultrasound) in mL
PSA	5 years after intervention	Changes of Prostate Specific Antigen (PSA, ng/mL)

Trial Locations

Locations (1)

St. Gallen Cantonal Hospital; 🇨🇭 St. Gallen, Saint Gallen, Switzerland