The Effects of Holmium Laser Enucleation and Thulium Laser Enucleation on Continence, Urethral Stricture, and Sexual Function in Benign Prostatic Hyperplasia

NCT ID: NCT07334730

Last Updated: 2026-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-02-01

Study Completion Date

2026-10-01

Brief Summary

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This study aims to evaluate the effects of Holmium Laser Enucleation of the Prostate (HoLEP) and Thulium Laser Enucleation of the Prostate (ThuLEP), performed for the treatment of benign prostatic hyperplasia (BPH), on the following parameters: urinary continence, development of urethral or bladder neck stricture, and sexual function, including erectile function, ejaculation, and libido.

Detailed Description

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Benign prostatic hyperplasia (BPH) is a progressive condition commonly affecting men, characterized by lower urinary tract symptoms (LUTS) that increase in prevalence and severity with age. Although medical therapy is effective for many patients, approximately 5% experience symptom progression requiring surgical intervention. While transurethral resection of the prostate (TURP) has long been considered the standard surgical treatment, technological advancements have enabled the widespread use of anatomical endoscopic enucleation of the prostate (AEEP) employing various laser modalities. Among these, Holmium laser enucleation of the prostate (HoLEP) and thulium laser enucleation of the prostate (ThuLEP) are established minimally invasive techniques used in the surgical management of BPH.

Detailed Description

Recent studies have demonstrated comparable perioperative and functional outcomes between HoLEP and ThuLEP, with no significant differences reported in terms of urinary retention, stress urinary incontinence, bladder neck contracture, or urethral stricture formation. However, postoperative evolution of urinary continence, overactive bladder symptoms, and sexual function remains a clinically relevant concern, particularly regarding patients' quality of life. Despite the increasing use of laser-based enucleation techniques, comparative data focusing on continence status, urethral or bladder neck stricture development, and sexual function outcomes remain limited.

To reduce postoperative complications, several surgical technique modifications have been introduced, including en bloc enucleation, two-lobe and three-lobe techniques, as well as urethral mucosa-preserving approaches such as single-N and double-N techniques. These modifications aim to preserve periurethral and paracollicular tissues, particularly in proximity to the verumontanum, thereby potentially improving functional outcomes.

The prevalence of BPH continues to rise in the aging population, often accompanied by systemic comorbidities and the use of anticoagulant or antithrombotic medications, which are associated with an increased risk of postoperative bleeding and hemorrhagic complications. Consequently, there is a growing need to evaluate the long-term outcomes of minimally invasive surgical techniques in this patient population.

This study aims to address existing gaps in the literature by providing comparative data on the long-term functional outcomes of minimally invasive surgical approaches for BPH, thereby contributing to improved patient selection, surgical technique optimization, and postoperative quality-of-life outcomes.

Conditions

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Benign Prostate Obstruction (BPO)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Benign Prostatic Obstruction Patient Group

The effects of Holmium Laser Enucleation (HoLEP) and Thulium Laser Enucleation (ThuLEP) surgeries on continence, urethral stricture, and sexual function in patients with benign prostatic hyperplasia were investigated prospectively.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of benign prostatic hyperplasia (BPH).
* Indication for surgical treatment of BPH.
* Male patients aged 40-90 years.

Exclusion Criteria

* Patients with active urinary tract infection (UTI).
* Patients at high risk who cannot undergo spinal or general anesthesia.
* Patients with uncontrolled bleeding diathesis.
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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Halil Tosun

Halil Tosun Assistant Proffessor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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HALİL TOSUN, Assistant Professor

Role: PRINCIPAL_INVESTIGATOR

TC Erciyes University

EMRE C. AKINSAL, Assoc. Prof.

Role: STUDY_CHAIR

TC Erciyes University

Locations

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Erciyes University Faculty of Medicine, Department of Urology

Kayseri, Melikgazi, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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CEM DOĞAN, M.D.

Role: CONTACT

+905332826038

HALİL TOSUN, Assistant Professor

Role: CONTACT

+905385502776

Facility Contacts

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CEM DOĞAN, M.D.

Role: primary

+905332826038

HALİL TOSUN, Assistant Professor

Role: backup

+905385502776

Other Identifiers

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COMP_AFTER_HOLEP_THULEP_26

Identifier Type: -

Identifier Source: org_study_id

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