The Effects of Holmium Laser Enucleation and Thulium Laser Enucleation on Continence, Urethral Stricture, and Sexual Function in Benign Prostatic Hyperplasia

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age40-90
SponsorTC Erciyes University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 1 trial group
Group A: Benign Prostatic Obstruction Patient Group

Trial outcomes

Primary outcomes

1

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)

Time frame
Within 6 months after surgery

Secondary outcomes

1

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.

Time frame
within 6 months after surgery
2

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.

Time frame
Within 6 months after surgery
3

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).

Time frame
Within 6 months after surgery

Other outcomes

Sponsors and contacts

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