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NCT Number: NCT07334730

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

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.

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Key information

Age range

40 year–90 year

Sex eligibility

Male

Study type

Observational

Primary location

Erciyes University Faculty of Medicine, Department of Urology

Kayseri, Melikgazi, 38140, Turkey (Türkiye)

Location contact

CEM DOĞAN, M.D.

CONTACT

[email protected]

+905332826038

CEM DOĞAN, M.D.

SUB_INVESTIGATOR

HALİL TOSUN, Assistant Professor

CONTACT

[email protected]

+905385502776

HALİL TOSUN, Assistant Professor

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of Participants with Postoperative Urethral Stricture or Urinary Incontinance

    Time frame: Within 6 months after surgery

    Postoperative urethral stricture was defined as a maximum urinary flow rate (Qmax) of less than 15 mL/s on uroflowmetry at the first postoperative month, accompanied by a voiding curve pattern consistent with urethral obstruction. Postoperative urinary incontinence was defined as the presence of patient-reported urge or stress-type incontinence at the first postoperative month, supported by an increased score on the International Consultation on Incontinence Questionnaire (ICIQ)

Secondary outcomes

  1. Number of participants assessed for sexual function

    Time frame: within 6 months after surgery

    Patients' sexual function will be evaluated using the Male Sexual Health Questionnaire (MSHQ) and the International Index of Erectile Function-5 (IIEF-5) for both HoLEP and ThuLEP procedures.

  2. Number of participants with surgery-related complications

    Time frame: Within 6 months after surgery

    Surgical technique-related complications were defined as intraoperative or early postoperative events, including postoperative bleeding, prostatic capsular injury, and bladder perforation, and were classified according to the Clavien-Dindo classification system.

  3. Number of participants presenting with lower urinary tract symptoms

    Time frame: Within 6 months after surgery

    Lower urinary tract symptoms (LUTS) were categorized as storage and voiding symptoms. Storage symptoms included dysuria, nocturia, pollakiuria, and urge urinary incontinence, whereas voiding symptoms comprised weak urinary stream and delayed initiation of micturition. LUTS were assessed using the International Prostate Symptom Score (IPSS) and the International Consultation on Incontinence Questionnaire-Male Lower Urinary Tract Symptoms (ICIQ-MLUTS).

Study contacts

Contact information is provided by the study sponsor or research team.

CEM DOĞAN, M.D.

CONTACT

[email protected]

+905332826038

HALİL TOSUN, Assistant Professor

CONTACT

[email protected]

+905385502776

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

A Prospective Analysis of the Effects of Holmium Laser Enucleation (HoLEP) and Thulium Laser Enucleation (ThuLEP) on Continence, Urethral Stricture, and Sexual Function in Benign Prostatic Hyperplasia

Acronym: EHTCUS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 12, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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