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

NCT07334730 | Not Yet Recruiting

• 1 other identifier: COMP_AFTER_HOLEP_THULEP_26
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Benign Prostate Obstruction (BPO)

Keywords

HOLEP; THULEP; BPO; Urinary Incontinence; Sexual Function; Urethral Stricture; Benign Prostate Obstruction; Benign Prostate Hyperplasia; Holmium; Thulium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of participants assessed for sexual function

  within 6 months after surgery

• Number of participants with surgery-related complications

  Within 6 months after surgery

• Number of participants presenting with lower urinary tract symptoms

  Within 6 months after surgery

Study Arms (1)

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.

Eligibility Criteria

• Age: 40 Years - 90 Years
• Gender Eligibility Details: Benign prostatic obstruction is a male-specific condition
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult male patients treated surgically for benign prostatic obstruction.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University Faculty of Medicine, Department of Urology

Kayseri, Melikgazi, 38140, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence; Urethral Stricture; Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urethral Obstruction; Urethral Diseases; Prostatic Diseases; Genital Diseases, Male; Genital Diseases

Study Officials

• HALİL TOSUN, Assistant Professor

  TC Erciyes University

  PRINCIPAL INVESTIGATOR

• EMRE C. AKINSAL, Assoc. Prof.

  TC Erciyes University

  STUDY CHAIR

Central Study Contacts

CEM DOĞAN, M.D.

CONTACT

+905332826038; cemdogn96@gmail.com

HALİL TOSUN, Assistant Professor

CONTACT

+905385502776; htosun@erciyes.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Halil Tosun Assistant Proffessor

Study Record Dates

• First Submitted: December 31, 2025
• First Posted: January 12, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)