About this trial
This study aims to evaluate the effects of Holmium Laser Enucleation of the Prostate (HoLEP) and Thulium Laser Enucleation of the Prostate (ThuLEP), performed for the treatment of benign prostatic hyperplasia (BPH), on the following parameters: urinary continence, development of urethral or bladder neck stricture, and sexual function, including erectile function, ejaculation, and libido.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of benign prostatic hyperplasia (BPH).
Indication for surgical treatment of BPH.
Male patients aged 40-90 years.
Disqualifiers
Patients with active urinary tract infection (UTI).
Patients at high risk who cannot undergo spinal or general anesthesia.
Patients with uncontrolled bleeding diathesis.
Trial population
Adult male patients treated surgically for benign prostatic obstruction.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Number of Participants with Postoperative Urethral Stricture or Urinary Incontinance
Postoperative urethral stricture was defined as a maximum urinary flow rate (Qmax) of less than 15 mL/s on uroflowmetry at the first postoperative month, accompanied by a voiding curve pattern consistent with urethral obstruction. Postoperative urinary incontinence was defined as the presence of patient-reported urge or stress-type incontinence at the first postoperative month, supported by an increased score on the International Consultation on Incontinence Questionnaire (ICIQ)
Secondary outcomes
Number of participants assessed for sexual function
Patients' sexual function will be evaluated using the Male Sexual Health Questionnaire (MSHQ) and the International Index of Erectile Function-5 (IIEF-5) for both HoLEP and ThuLEP procedures.
Number of participants with surgery-related complications
Surgical technique-related complications were defined as intraoperative or early postoperative events, including postoperative bleeding, prostatic capsular injury, and bladder perforation, and were classified according to the Clavien-Dindo classification system.
Number of participants presenting with lower urinary tract symptoms
Lower urinary tract symptoms (LUTS) were categorized as storage and voiding symptoms. Storage symptoms included dysuria, nocturia, pollakiuria, and urge urinary incontinence, whereas voiding symptoms comprised weak urinary stream and delayed initiation of micturition. LUTS were assessed using the International Prostate Symptom Score (IPSS) and the International Consultation on Incontinence Questionnaire-Male Lower Urinary Tract Symptoms (ICIQ-MLUTS).
Sponsors and contacts
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