---
title: "Comparison of Holmium, Thulium:YAG, and Thulium Fiber Lasers in Prostate Enucleation"
nct_id: NCT07350005
overall_status: NOT_YET_RECRUITING
phase: NA
sponsor: Ankara University
study_type: INTERVENTIONAL
primary_condition: BPH (Benign Prostatic Hyperplasia)
countries: Turkey (Türkiye)
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07350005.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07350005"
ct_last_update_post_date: 2026-01-20
last_seen_at: "2026-05-12T06:21:44.943Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Comparison of Holmium, Thulium:YAG, and Thulium Fiber Lasers in Prostate Enucleation

**Official Title:** A Prospective Randomized Study Comparing the Efficiency and Safety of Holmium:YAG, Thulium:YAG, and Thulium Fiber Lasers in Anatomical Prostate Enucleation

**NCT ID:** [NCT07350005](https://clinicaltrials.gov/study/NCT07350005)

## Key Facts

- **Status:** NOT_YET_RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 159
- **Lead Sponsor:** Ankara University
- **Conditions:** BPH (Benign Prostatic Hyperplasia)
- **Start Date:** 2026-05
- **Completion Date:** 2028-01
- **CT.gov Last Update:** 2026-01-20

## Brief Summary

Benign prostatic hyperplasia (BPH) is a common condition in aging men and may require surgical treatment when medical therapy is ineffective. Anatomical prostate enucleation using different laser technologies is a well-established surgical approach for the treatment of BPH.

The purpose of this prospective randomized study is to compare the efficiency and safety of three commonly used laser systems-Holmium:YAG, Thulium:YAG, and Thulium Fiber Laser (TFL)-during anatomical prostate enucleation.

The primary objective of the study is to evaluate laser efficiency by measuring grams of enucleated prostate tissue per joule (g/J) using intraoperative laser device data. Secondary outcomes include changes in International Prostate Symptom Score (IPSS) and the occurrence of postoperative urinary incontinence.

All laser systems used in this study are part of routine clinical practice, and no additional diagnostic procedures or treatments will be performed for study purposes

## Detailed Description

This is a prospective, randomized, single-center clinical study designed to compare the efficiency and safety of three different laser systems used in anatomical prostate enucleation for the surgical treatment of benign prostatic hyperplasia (BPH).

Eligible patients will be randomly assigned to undergo prostate enucleation using one of the following laser technologies: Holmium:YAG laser, Thulium:YAG laser, or Thulium Fiber Laser (TFL). All procedures will be performed according to standard surgical techniques routinely used in clinical practice.

The primary outcome of the study is laser efficiency, which will be evaluated using intraoperative laser system data,including grams of enucleated prostate tissue per joule (g/J). Preoperative prostate volume and intraoperative laser parameters are routinely recorded and will be used for analysis. No additional diagnostic procedures or treatments will be performed specifically for study purposes.

Secondary outcomes include changes in the International Prostate Symptom Score (IPSS) from preoperative assessment to postoperative follow-up and the presence of postoperative urinary incontinence. Safety assessment will be based on perioperative and postoperative adverse events recorded during routine clinical care.

The study will be conducted in accordance with ethical principles and applicable regulatory requirements, and patient confidentiality will be maintained throughout the study period.

## Eligibility

- **Minimum age:** 50 Years
- **Maximum age:** 80 Years
- **Sex:** MALE
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Patients diagnosed with benign prostatic hyperplasia (BPH) and scheduled for anatomical prostate enucleation
* Presence of a prostate and clinical indication for surgical treatment
* Age between 50 and 80 years

Exclusion Criteria:

* History or suspicion of prostate cancer
* Previous prostate surgery
* Presence of neurogenic bladder or significant lower urinary tract dysfunction unrelated to BPH
* Active urinary tract infection at the time of surgery
* Severe comorbid conditions contraindicating surgery or anesthesia
```

## Arms

- **Holmium:YAG Laser Enucleation** (ACTIVE_COMPARATOR) — Participants in this arm will undergo anatomical prostate enucleation using Holmium:YAG laser as part of standard surgical treatment for benign prostatic hyperplasia.
- **Thulium:YAG Laser Enucleation** (ACTIVE_COMPARATOR) — Participants in this arm will undergo anatomical prostate enucleation using Thulium:YAG laser as part of standard surgical treatment for benign prostatic hyperplasia.
- **Thulium Fiber Laser (TFL) Enucleation** (ACTIVE_COMPARATOR) — Participants in this arm will undergo anatomical prostate enucleation using Thulium Fiber Laser (TFL) as part of standard surgical treatment for benign prostatic hyperplasia.

## Interventions

- **Holmium:YAG Laser Prostate Enucleation** (PROCEDURE) — Anatomical prostate enucleation performed using a Holmium:YAG laser system as part of standard surgical treatment for benign prostatic hyperplasia.
- **Thulium:YAG Laser Prostate Enucleation** (PROCEDURE) — Anatomical prostate enucleation performed using a Thulium:YAG laser system as part of standard surgical treatment for benign prostatic hyperplasia.
- **Thulium Fiber Laser Prostate Enucleation** (PROCEDURE) — Anatomical prostate enucleation performed using a Thulium Fiber Laser (TFL) system as part of standard surgical treatment for benign prostatic hyperplasia.

## Primary Outcomes

- **Laser Enucleation Efficiency (g/J)** _(time frame: Intraoperative)_ — Laser enucleation efficiency will be evaluated by calculating the amount of enucleated prostate tissue in grams per joule of laser energy used (g/J), based on intraoperative laser system data and enucleated tissue weight recorded during surgery.

## Secondary Outcomes

- **Change in International Prostate Symptom Score (IPSS)** _(time frame: Baseline (preoperative) and 3 months postoperatively)_
- **Postoperative Urinary Incontinence** _(time frame: Up to 3 months postoperatively)_

## Locations (1)

- Ankara University, Ankara, Turkey (Türkiye)

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.ankara university|ankara||turkey (türkiye)` — added _(2026-05-12)_

---

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