The Learning Curve of Transurethral Holmium Laser Enucleation of the Prostate, Prospective Assessment

NCT06038890 | Unknown DMC

• 1 other identifier: Mans.9.2023
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Despite the high-quality evidence supporting the safety and efficacy of Holmium laser enucleation of the prostate (HOLEP), wide adoption of the procedure is hindered by learning difficulties. Veil-sparing HOLEP was popularized with a standardized approach to learning. Prospective multicenter assessment of the learning curve of HoLEP through a novel technique with structured learning protocol. Learning outcome measures will be assessed against time and number of performed cases of new learners in a multicenter study.

Conditions

Learning Curve; Laser; Prostate Hyperplasia

Outcome Measures

Primary Outcomes (1)

• time to plateau in enucleation effeminacy

  time needed to reach a fixed rate of grams of prostate tissue removed per unit time (minute)

  one year

Study Arms (1)

Holmium laser enculeation of the prostate

EXPERIMENTAL

veil-sparing Holmium laser enucleation of the prostate

Procedure: Holmium laser enucleation of the prostate using the veil-sparing technique

Interventions

Holmium laser enucleation of the prostate using the veil-sparing technique PROCEDURE

Holmium laser enucleation of the prostate using the veil-sparing technique

Holmium laser enculeation of the prostate

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: prostate surgery offered only for men
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with prostate volume (≥40 cc) who are indicated for transurethral surgery for the BPO.

You may not qualify if:

• Patients with IPSS \<13.
• Patients with Qmax \>15 mL/s.
• Presence of urethral stricture.
• Patients with neurogenic bladder.
• Patients with prostate cancer.
• Patients with previous prostate surgery.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and nephrology center

Al Mansurah, DK, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Urology

Model Details: A single cohort of consecutively performed cases in participating centers done by new learners using the assigned technique

Study Record Dates

• First Submitted: September 10, 2023
• First Posted: September 15, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 15, 2023

Record last verified: 2023-09

Locations

EG (1)