Anesthesia Type and HoLEP Outcomes: A Multi-Center Study

NCT07585552 | Not Yet Recruiting

• 1 other identifier: MIUS.2026.002
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

• Requirement for the usage of any vasoactive medication due to low blood pressure
• Time passed until discharge.
• Time passed until the removal of the bladder drainage catheter.
• Ratio of the unwanted events that require additional intervention other than medication, fluids, or blood transfusions (Complications, Clavien-Dindo Grade III or higher).
• International symptom questionnaire score 3 months after surgery.
• Quality of life (QoL) score 3 months after surgery.
• Peak urinary current velocity (Qmax) and post-void residual volume measurement 3 months after surgery.
• Can anyone participate in this study?
• Being older than 18 years old.
• Having bothersome lower urinary tract symptoms due to prostatic enlargement requiring surgical treatment.
• Having no untreated or uncontrolled systemic disease, which refers to having an ASA (American Society of Anesthesiologists Physical Status Classification System) score III at most.

Conditions

Benign Prostatic Hyperplasia With Symptomatic Lower Urinary Tract Symptoms

Keywords

HoLEP; Benign Prostate Obstruciton (BPO); Male LUTS; Real World Study; Observational Study

Outcome Measures

Primary Outcomes (1)

• Hemoglobin change

  Difference between preoperative and postoperative hemoglobin levels (g/dL)

  First day after HoLEP is performed.

Secondary Outcomes (8)

• International Prostate Symptom with quality of life score (IPSS-QoL) at 3 months after surgery

  At 3 months after HoLEP

• Duration of hospitalization

  Postoperative second to seventh days after HoLEP.

• Duration of catheterization

  From the time of HoLEP until the removal of the catheter.

• Ratio of high grade complications

  From the time of HoLEP to 30 days after HoLEP.

• Peak Urinary Flow (Qmax)

  At 3 months after HoLEP.

Study Arms (2)

General Anesthesia

Participants undergoing HoLEP under general anesthesia (intubation or laryngeal mask airway)

Spinal Anesthesia

Participants undergoing HoLEP under spinal anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male patients undergoing HoLEP for BPO.

You may qualify if:

• years or older men who have BPO requiring surgical treatment.
• Participants who can give written informed consent.
• Having no more than 3 points for the American Society of Anesthesiologists (ASA) physical status classification scale (ASA 1 to 3).

You may not qualify if:

• Absolute contraindication for spinal or general anesthesia
• History of previous surgery for prostate (e.g., surgery for prostate cancer, surgery for benign prostate obstruction)
• Uncorrected bleeding disorder (INR \> 1.5)
• Participants who are not willing to give informed consent.
• Participants who have a proven urinary tract infection at the time of the surgery.
• Participants who are not able to be contacted for regular follow-ups.

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayis University, Faculty of Medicine, Department of Urology

Samsun, Turkey (Türkiye)

Location

Related Publications (3)

• Haehn DA, Chadha RM, Porter SB, Pathak RA, Lyon TD, Hochwald AP, Dora CD. Same-day Discharge Following Holmium Laser Enucleation of the Prostate Under Spinal Anesthesia: A Propensity Score Matched Comparison With General Anesthesia. Urology. 2025 Feb;196:260-264. doi: 10.1016/j.urology.2024.11.058. Epub 2024 Nov 30.

  PMID: 39622439 BACKGROUND

• Silvani C, Lucignani G, Bebi C, Turetti M, Ripa F, Zanetti SP, De Lorenzis E, Albo G, Longo F, Gadda F, Montanari E, Boeri L. General anesthesia is associated with lower perioperative bleeding and better functional outcomes than spinal anesthesia for endoscopic enucleation of the prostate: a single-center experience. World J Urol. 2024 Oct 9;42(1):569. doi: 10.1007/s00345-024-05271-z.

  PMID: 39382595 BACKGROUND

• Westhofen T, Schott M, Keller P, Tamalunas A, Atzler M, Ebner B, Schultheiss M, Damm A, Kowalski C, Stief CG, Magistro G. Spinal Versus General Anesthesia for Holmium Laser Enucleation of the Prostate of High-risk Patients - A Propensity-score-matched-analysis. Urology. 2022 Jan;159:182-190. doi: 10.1016/j.urology.2021.04.078. Epub 2021 Jul 31.

  PMID: 34339752 BACKGROUND

Study Officials

• Murat Gulsen

  Ondokuz Mayıs University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Murat Gulsen, Assistant Professor

CONTACT

+905062357421; mglotr@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 13, 2026
• Study Start: April 23, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)