Clinical trial NCT03583034: Outcomes and Complications of Holmium Laser Enucleation of the Prostate in Expert Hands
Official title: Prospective Assessment of Outcomes and Complications of Patients Submitted to Holmium Laser Enucleation of the Prostate (HoLEP) in a High Volume Center
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Benign Prostatic Hyperplasia
Keywords: HoLEP
Prostate
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2018-07-11
Enrollment: 275
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients submitted to surgery for bladder outlet obstruction (BOO) due to BPH

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.

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)

Primary outcomes:
measure: Functional outcomes as assessed with IPSS questionnaire
timeFrame: 12 months
Secondary outcomes:
measure: Identification of clinical characteristics associated with risk of post-operative complications (recorded according to the Clavien-Dindo classification)
timeFrame: 12 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
state: MI
Study officials:
References: