HoLEP vs BPRP of a Large Volume BPH: a Randomised Controlled Trial

Cairo University (CU)

Status: Completed

Conditions: BPH With Urinary Obstruction; Male

Treatments: Procedure: Bipolar resection of the prostate; Procedure: holmium laser enucleation of the prostate

Study type: Interventional

Funder types: Other

Identifiers

NCT04143399

62513

Details and patient eligibility

About

To compare bipolar resection versus holmium laser enucleation for management of large BPH.

Full description

To compare safety and efficacy of bipolar resection (BPRP) versus holmium laser enucleation (HoLEP) for management of large BPH (> 75 gm).

Enrollment: 145 patients

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients suffering from LUTS secondary to infravesical obstruction from BPH
• failed medical treatment
• International Prostate Symptom Score (IPSS) > 13
• a peak urinary flow rate (Qmax) < 15 ml/sec
• a prostate size ≥ 75 gm

Exclusion criteria

• presence of a urethral stricture
• neurological disorder
• bladder cancer
• prostate cancer
• previous history of bladder neck surgery or TURP

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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145 participants in 2 patient groups

holmium laser enucleation of the prostate

Active Comparator group

Description:

holmium laser enucleation of the prostate (HoLEP)

Treatment:

Procedure: holmium laser enucleation of the prostate

bipolar resection of the prostate

Active Comparator group

Description:

bipolar resection of the prostate (BPEP)

Treatment:

Procedure: Bipolar resection of the prostate