Database for the Assessment of Efficacy and Safety of BPH Treatment

NCT ID: NCT03521648

Last Updated: 2021-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-07

Study Completion Date

2027-12-01

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.

Conditions

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Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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PAE

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

PAE

Intervention Type PROCEDURE

Prostatic artery embolization

TURP

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

TURP

Intervention Type PROCEDURE

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.

Other

Intervention Type 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

Interventions

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PAE

Prostatic artery embolization

Intervention Type PROCEDURE

TURP

Transurethral resection of the prostate

Intervention Type 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

Intervention Type PROCEDURE

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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Dominik Abt

OTHER

Sponsor Role lead

Responsible Party

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Dominik Abt

Dr. med. Dominik Abt

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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St. Gallen Cantonal Hospital

Sankt Gallen, Canton of St. Gallen, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Dominik Abt, MD

Role: CONTACT

+41 71 494 14 16

Gautier Müllhaupt, MD

Role: CONTACT

+41 71 494 14 16

Facility Contacts

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Dominik Abt, MD

Role: primary

+41714941416

Other Identifiers

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CTU P-17/006

Identifier Type: -

Identifier Source: org_study_id

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