Holmium Laser Versus Thulium Laser Versus Bipolar Enucleation of the Prostate.

Mansoura University

Status: Completed

Conditions: Prostate Hypertrophy; Holmium Laser; Thulium Laser; Bipolar Diathermy; Prostate Enucleation

Treatments: Procedure: Thulium Laser; Procedure: Bipolar diathermy; Procedure: Holmium Laser

Study type: Interventional

Funder types: Other

Identifiers

NCT03916536

Prostate Enucleation

Details and patient eligibility

About

Because of the diversity of the studies and deficiency of those comparing various techniques of EEP for treatment of LUTs secondary to BPO in patients with large sized prostate, we aim in this study at testing the non-inferiority of PKEP and ThuLEP to HoLEP in relieving LUTs secondary to BPO in patients prostate size >80ml. Our hypothesis is to present an evidence that enucleation is a technique rather than a power dependent procedure through a RCT.

Enrollment: 155 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients' age >50 years
• Lower urinary tract symptoms LUTS secondary benigh prostatic obstruction BPO who failed medical treatment
• International prostate symptom scores (IPSS) >15 and bother score quality of life (QOL) > 3 (according to IPSS question 8)
• Maximum urinary flow rate (Q max) <15 ml/sec with at least 150 ml voided volume or cases with acute urine retention secondary to BPO who failed trial of voiding on medical treatment.
• Transrectal ultrasound TRUS estimated total prostate size 80-250cc

Exclusion criteria

• Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease
• Active urinary tract infection (positive urine culture) till treatment
• Presence of bladder cancer (within the last 2 years)
• Known prostate cancer patients will be excluded preoperatively on the basis of digital rectal examination, prostate specific antigen level, and TRUS imaging followed by prostate biopsies if necessary.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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155 participants in 3 patient groups

Holmium Laser

Active Comparator group

Description:

holmium laser enucleation of the prosteate

Treatment:

Procedure: Holmium Laser

Thulium Laser

Active Comparator group

Description:

Thulium laser enucleation of the prosteate

Treatment:

Procedure: Thulium Laser

Bipolar Enucleation

Active Comparator group

Description:

Bipolar enucleation of the prosteate

Treatment:

Procedure: Bipolar diathermy