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

NCT ID: NCT03583034

Last Updated: 2018-07-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 275 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-18
• Study Completion Date: 2020-06-18

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.

Detailed Description

This is a prospective case-series study collecting data of patients treated with HoLEP at a single academic center. Patients submitted to surgery for bladder outlet obstruction (BOO) due to BPH will be consecutively included. All surgeries will be performed by two experienced surgeons with more than 1000 procedures performed (FM; GB).

Patients with neurological diseases and those with a history of previous surgery of the lower urinary tract (e.g. urethra and prostate surgery) will be excluded.

At the time of primary screening, all patients will be assessed with a comprehensive medical history; other pre-operative data will include: prostate volume (as assessed with trans-rectal prostate ultrasound); uroflowmetry parameters; total Prostate specific Antigen (PSA); baseline haemoglobin and creatinine level. Moreover, all patients will be invited to fill psychometric validated questionnaires assessing pre-operative urinary and sexual function, thus including: the International Prostatic Symptoms Score (IPSS); the International Index of Erectile Function (IIEF); the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF); and the Overactive Bladder Questionnaire (OABq). Moreover, urinary continence (UC) will be further assessed with a single question, and UC defined as no-pad use. Patients' medications will be also recorded.

Intra-operative data will be collected at the time of surgery, including: patients' systolic blood pressure; laser settings; enucleation efficiency (weight of enucleated tissue divided by lasing time) and morcellation efficiency (weight of enucleated tissue divided by morcellation time). Moreover, surgeons will be requested to provide a subjective estimation of the difficulty of the procedure with a 10-point Likert scale.

Post-operative data including: length of stay; timing of catheter removal and complications, will be also collected.

All patients will be re-assessed at 1 week after surgery to check for UC. Subjective symptoms, as assessed with validated questionnaires (IPSS; IIEF, ICIQ-SF; OABq), along with post-operative complications and medications used, will be firstly assessed at 1 month after surgery. All patients will undergo a first uroflowmetry evaluation at 3 months after surgery; at this time-point data on blood tests (total PSA, haemoglobin and creatinine), urine culture and symptoms scores will be collected.

A final assessment will be performed at 1 year after surgery including: blood tests, uroflowmetry, IPSS, IIEF, ICIQ-SF, OABq and complications.

Over the follow-up period, the prevalence of patients needing medications for disturbing symptoms will be recorded; moreover, pelvic floor training (PFT) will be suggested to each patient reporting pad-use for urinary incontinence.

Conditions

Benign Prostatic Hyperplasia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Holmium laser enucleation of the prostate (HoLEP)

Surgery for benign prostatic hyperplasia

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

IRCCS San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Francesco Montorsi

Chairman Department of Urology IRCCS San Raffaele Hospital Professor of Urology Vita Salute San Raffaele University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS Ospedale San Raffaele

Milan, MI, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Paolo Capogrosso, MD

Role: CONTACT

capogrosso.paolo@hsr.it

+390226437286

Facility Contacts

Paolo Capogrosso, MD

Role: primary

paolo.capogrosso@gmail.com

+390226437286

References

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.

Reference Type: DERIVED

PMID: 37069007 (View on PubMed)

Other Identifiers

ExpHo study

Identifier Type: -

Identifier Source: org_study_id