Holmium Laser vs Bipolar Enucleation of a Large Volume BPH: a Randomised Controlled Study

Cairo University (CU)

Status: Completed

Conditions: BPH With Urinary Obstruction; Male

Treatments: Procedure: Bipolar plasma kinetic enucleation of the prostate; Procedure: Holmium laser enucleation of the prostate

Study type: Interventional

Funder types: Other

Identifiers

NCT03998150

61647

Details and patient eligibility

About

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

Full description

To compare safety and efficacy of bipolar plasmakinetic enucleation (BPEP) versus holmium laser enucleation (HoLEP) for management of large BPH (>80gm).

Enrollment: 64 patients

Sex: Male

Ages: 40+ 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 ≥ 80 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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64 participants in 2 patient groups

HoLEP holmium laser enucleation of the prostate

Active Comparator group

Description:

holmium laser enucleation of the prostate

Treatment:

Procedure: Holmium laser enucleation of the prostate

BPEP bipolar plasmakinetic enucleation of the prostate

Active Comparator group

Description:

bipolar plasmakinetic enucleation of the prostate

Treatment:

Procedure: Bipolar plasma kinetic enucleation of the prostate