Outcomes and Complications of Holmium Laser Enucleation of the Prostate in Expert Hands

NCT03583034 | Unknown

• 1 other identifier: ExpHo study
• Study Type: observational
• Target: 275
• Locations: 1 country
• Sites: 1

Brief Summary

The efficacy and safety of holmium laser enucleation of the prostate (HoLEP) for the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) have been comprehensively assessed. However, HoLEP is considered as a challenging procedure with a steep learning curve. As such, HoLEP is not as yet considered the gold standard for the surgical treatment of LUTS/BPH by international clinical guidelines. The investigators aim to assess the complications and outcomes of patients treated with HoLEP by high volume surgeons, in order to provide data on the safety of the procedure and identify the profile of patients who may benefit from a dedicated clinical management to reduce the risk of post-operative complications.

Conditions

Benign Prostatic Hyperplasia

Keywords

HoLEP; Prostate

Outcome Measures

Primary Outcomes (1)

• Functional outcomes as assessed with IPSS questionnaire

  functional urinary outcomes will be assessed with IPSS questionnaire at different time points over the first year after surgery.

  12 months

Secondary Outcomes (1)

• Identification of clinical characteristics associated with risk of post-operative complications (recorded according to the Clavien-Dindo classification)

  12 months

Interventions

Holmium laser enucleation of the prostate (HoLEP) PROCEDURE

Surgery for benign prostatic hyperplasia

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients submitted to surgery for bladder outlet obstruction (BOO) due to BPH

You may qualify if:

• Patients with lower urinary tract symptoms due to benign prostatic hyperplasia

You may not qualify if:

• neurological diseases; previous surgery on the lower urinary tract (urethra/prostate)

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, MI, 20132, Italy

RECRUITING

Related Publications (1)

• Capogrosso P, Ventimiglia E, Fallara G, Schifano N, Costa A, Candela L, Pellegrino F, Colandrea G, Cignoli D, De Angelis M, Belladelli F, Longoni M, Avesani G, Lanzaro F, Scattoni V, Deho F, Salonia A, Briganti A, Montorsi F. Holmium Laser Enucleation of the Prostate Is Associated with Complications and Sequelae Even in the Hands of an Experienced Surgeon Following Completion of the Learning Curve. Eur Urol Focus. 2023 Sep;9(5):813-821. doi: 10.1016/j.euf.2023.03.018. Epub 2023 Apr 15.

  PMID: 37069007 DERIVED

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Paolo Capogrosso, MD

CONTACT

+390226437286; capogrosso.paolo@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman Department of Urology IRCCS San Raffaele Hospital Professor of Urology Vita Salute San Raffaele University

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: July 11, 2018
• Study Start: June 18, 2018
• Primary Completion: April 18, 2019
• Study Completion: June 18, 2020
• Last Updated: July 12, 2018

Record last verified: 2018-07

Locations

IT (1)