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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Benign Prostate Obstruction (BPO)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: CEM DOĞAN, M.D.; Phone Number: +905332826038; Email: cemdogn96@gmail.com
• Study Contact Backup: Name: HALİL TOSUN, Assistant Professor; Phone Number: +905385502776; Email: htosun@erciyes.edu.tr

Study Locations

• Turkey (Türkiye)
  • Melikgazi
    • Kayseri, Melikgazi, Turkey (Türkiye), 38140
      • Erciyes University Faculty of Medicine, Department of Urology
      • Contact: CEM DOĞAN, M.D.; Phone Number: +905332826038; Email: cemdogn96@gmail.com
      • Contact: HALİL TOSUN, Assistant Professor; Phone Number: +905385502776; Email: htosun@erciyes.edu.tr
      • Principal Investigator: HALİL TOSUN, Assistant Professor
      • Sub-Investigator: CEM DOĞAN, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult male patients treated surgically for benign prostatic obstruction.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Postoperative Urethral Stricture or Urinary Incontinance	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)	Within 6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants assessed for sexual function	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.	within 6 months after surgery
Number of participants with surgery-related complications	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.	Within 6 months after surgery
Number of participants presenting with lower urinary tract symptoms	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).	Within 6 months after surgery

Collaborators and Investigators

• Sponsor: TC Erciyes University
• Investigators: Principal Investigator: HALİL TOSUN, Assistant Professor, TC Erciyes University; Study Chair: EMRE C. AKINSAL, Assoc. Prof., TC Erciyes University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: December 31, 2025
• First Submitted That Met QC Criteria: December 31, 2025
• First Posted (Estimated): January 12, 2026

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: December 31, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Benign Prostate Hyperplasia; Urinary Incontinence; Sexual Function; BPO; HOLEP; Thulium; Holmium; Urethral Stricture; THULEP; Benign Prostate Obstruction
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Urethral Diseases; Urethral Obstruction; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence; Prostatic Hyperplasia; Urethral Stricture
• Other Study ID Numbers: COMP_AFTER_HOLEP_THULEP_26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No