HoLEP vs BipolEP in Management of BPH Patients With Large Prostates

Assiut University

Status: Enrolling

Conditions: Benign Prostatic Hyperplasia

Treatments: Procedure: Holmium Laser Enucleation of the Prostate; Procedure: Bipolar Enucleation of the Prostate

Study type: Interventional

Funder types: Other

Identifiers

NCT06759194

HoLEP vs BipolEP

Details and patient eligibility

About

This is a non-inferiority prospective randomized comparative clinical trial aiming to prove the non-inferiority of bipolar enucleation of the prostate in comparison to holmium laser enucleation of the prostate in management of benign prostatic hyperplasia patients with large prostates and in turn its feasibility as an alternative procedure in hospitals with limited resources

Full description

Benign prostatic hyperplasia (BPH) is a prevalent condition among older men. It is characterized by non-cancerous enlargement of the prostate gland often leading to urinary obstruction and significant morbidity. In case of failure of medical treatment, surgical intervention is often required especially in patients with larger prostates. Surgical options in such cases include Holmium Laser Enucleation of the Prostate (HoLEP) and Bipolar Enucleation of the Prostate (BipolEP). These modalities have emerged as promising relatively minimally invasive treatment options in patients with large prostates. HoLEP, utilizing laser technology to enucleate prostatic tissue, has been associated with reduced intraoperative blood loss, shorter catheterization time, and quicker recovery in comparison to open prostatectomy. Likewise, BipolEP, utilizing bipolar energy for enucleation, offers the advantage of reduced bleeding and shorter operative time. Both HoLEP and BipolEP have demonstrated efficacy in improving lower urinary tract symptoms (LUTS) and alleviating obstruction in BPH patients with large prostates, but the comparative efficacy and safety of both techniques remains highly debated. This study aims to compare the efficacy and safety of these two surgical modalities aiming to provide valuable insights that can enhance clinical decision-making and patient care in BPH management.

Enrollment: 98 estimated patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >50 years
• Prostate volume >80 ml
• Failure of or noncompliance with medical treatment
• IPSS >15
• Qmax <15 ml/sec
• Urinary retention and fixed catheters with poor results on trial of voiding without catheter

Exclusion criteria

• Patients with active UTI
• Prostate cancer
• Bladder carcinoma
• Urethral stricture
• Neurogenic bladder disorders
• Redo cases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

98 participants in 2 patient groups

Holmium Laser Enucleation of the Prostate (HoLEP)

Active Comparator group

Description:

Half of the BPH patients with large prostate admitted to the study will undergo Holmium Laser Enucleation of the Prostate (HoLEP)

Treatment:

Procedure: Holmium Laser Enucleation of the Prostate

Bipolar Enucleation of the Prostate (BipolEP)

Active Comparator group

Description:

Half of the BPH patients with large prostate admitted to the study will undergo Bipolar Enucleation of the Prostate (BipolEP)

Treatment:

Procedure: Bipolar Enucleation of the Prostate