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Clinical Trials in Turkey / NCT07585552
Starting soon Observational

Anesthesia Type and HoLEP Outcomes: A Multi-Center Study

NCT07585552 · tracked via the Priya Life Science Turkey tracker
Sponsor
Ondokuz Mayıs University
Phase
Observational
Started
2026-04-23
Last updated
2026-05-13

Condition(s) studied

Benign Prostatic Hyperplasia With Symptomatic Lower Urinary Tract Symptoms

Study summary

1. What is this study about, and why is it required?

The goal of this observational study is to learn if anesthesia type (e.g., general anesthesia, spinal anesthesia) affects the safety and efficiency of HoLEP surgery. The main question it aims to answer is:

\- Is a particular type of anesthesia related to less or more bleeding during the surgery?
2. What will be assessed to answer the main question of this study? (Outcome measure(s))

2.1. Primary outcome measure of this study is:

\- Change in the hemoglobin level perioperatively.

2.2. Secondary outcome measures are:
* 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.
3. Can anyone participate in this study?

Voluntary participants should meet the following criteria:

* 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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 18 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). Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Hemoglobin change — First day after HoLEP is performed.
    Difference between preoperative and postoperative hemoglobin levels (g/dL)

Trial sites (1)

FacilityCityRegionStatus
Ondokuz Mayis University, Faculty of Medicine, Department of Urology Samsun Turkey (Türkiye)

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07585552 on ClinicalTrials.gov ↗ ← All trials in Turkey