Database for the Assessment of Efficacy and Safety of BPH Treatment

NCT03521648 | Recruiting

• 1 other identifier: CTU P-17/006
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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).

Conditions

Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia

Keywords

Prostatic Artery Embolization; Transurethral Prostate Resection; Transurethral Electroresection of Prostate; Contact Laser Ablation of Prostate; Laser Enucleation of Prostate; Open prostatectomy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (54)

• Reduction of Lower Urinary Tract Symptoms

  baseline to 6 weeks

• Reduction of Lower Urinary Tract Symptoms

  baseline to 12 weeks

• Reduction of Lower Urinary Tract Symptoms

  baseline to 6 months

• Reduction of Lower Urinary Tract Symptoms

  baseline to 2 years

• Reduction of Lower Urinary Tract Symptoms

  baseline to 5 years

Study Arms (3)

PAE

Men with BPH - LUTS BPE who have opted for PAE and have consented to take part in the Register Study.

Procedure: PAE

TURP

Men with BPH - LUTS BPE who have opted for TURP and have consented to take part in the Register Study.

Procedure: TURP

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

Interventions

PAE PROCEDURE

Prostatic artery embolization

PAE

TURP PROCEDURE

Transurethral resection of the prostate

TURP

Other PROCEDURE

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

Other

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• All patients treated for BPH / LUTS / prostatic obstruction at the urological department of KSSG
• Patient age ≥ 18 years
• Informed consent provided

You may not qualify if:

• Cognitive impairment not allowing Informed Consent or adequate data assessment.

Sponsors & Collaborators

• Dominik Abt: lead

Study Sites (1)

St. Gallen Cantonal Hospital

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

RECRUITING

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Prostatic Hyperplasia

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Dominik Abt, MD

CONTACT

+41 71 494 14 16; dominik.abt@kssg.ch

Gautier Müllhaupt, MD

CONTACT

+41 71 494 14 16; Gautier.muellhaupt@kssg.ch

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. med. Dominik Abt

Study Record Dates

• First Submitted: April 29, 2018
• First Posted: May 11, 2018
• Study Start: July 7, 2017
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 26, 2021

Record last verified: 2021-01

Locations

CH (1)