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

TC Erciyes University

Status: Not yet enrolling

Conditions: Benign Prostate Obstruction (BPO)

Study type: Observational

Funder types: Other

Identifiers

NCT07334730

COMP_AFTER_HOLEP_THULEP_26

Details and patient eligibility

About

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.

Full description

Benign prostatic hyperplasia (BPH) is a progressive condition commonly affecting men, characterized by lower urinary tract symptoms (LUTS) that increase in prevalence and severity with age. Although medical therapy is effective for many patients, approximately 5% experience symptom progression requiring surgical intervention. While transurethral resection of the prostate (TURP) has long been considered the standard surgical treatment, technological advancements have enabled the widespread use of anatomical endoscopic enucleation of the prostate (AEEP) employing various laser modalities. Among these, Holmium laser enucleation of the prostate (HoLEP) and thulium laser enucleation of the prostate (ThuLEP) are established minimally invasive techniques used in the surgical management of BPH.

Detailed Description

Recent studies have demonstrated comparable perioperative and functional outcomes between HoLEP and ThuLEP, with no significant differences reported in terms of urinary retention, stress urinary incontinence, bladder neck contracture, or urethral stricture formation. However, postoperative evolution of urinary continence, overactive bladder symptoms, and sexual function remains a clinically relevant concern, particularly regarding patients' quality of life. Despite the increasing use of laser-based enucleation techniques, comparative data focusing on continence status, urethral or bladder neck stricture development, and sexual function outcomes remain limited.

To reduce postoperative complications, several surgical technique modifications have been introduced, including en bloc enucleation, two-lobe and three-lobe techniques, as well as urethral mucosa-preserving approaches such as single-N and double-N techniques. These modifications aim to preserve periurethral and paracollicular tissues, particularly in proximity to the verumontanum, thereby potentially improving functional outcomes.

The prevalence of BPH continues to rise in the aging population, often accompanied by systemic comorbidities and the use of anticoagulant or antithrombotic medications, which are associated with an increased risk of postoperative bleeding and hemorrhagic complications. Consequently, there is a growing need to evaluate the long-term outcomes of minimally invasive surgical techniques in this patient population.

This study aims to address existing gaps in the literature by providing comparative data on the long-term functional outcomes of minimally invasive surgical approaches for BPH, thereby contributing to improved patient selection, surgical technique optimization, and postoperative quality-of-life outcomes.

Enrollment: 200 estimated patients

Sex: Male

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of benign prostatic hyperplasia (BPH).
• Indication for surgical treatment of BPH.
• Male patients aged 40-90 years.

Exclusion criteria

• Patients with active urinary tract infection (UTI).
• Patients at high risk who cannot undergo spinal or general anesthesia.
• Patients with uncontrolled bleeding diathesis.

Trial design

200 participants in 1 patient group

Benign Prostatic Obstruction Patient Group

Description:

The effects of Holmium Laser Enucleation (HoLEP) and Thulium Laser Enucleation (ThuLEP) surgeries on continence, urethral stricture, and sexual function in patients with benign prostatic hyperplasia were investigated prospectively.