Effect of Catheter Duration on Prostate Laser Enucleation Surgery Outcomes in Patients With Urinary Retention

NCT07603011 | Recruiting

• 1 other identifier: E-25403353-050.04-260029122
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Benign Prostatic Obstruction (BPO) is a common condition in aging men that can lead to urinary retention, often requiring the use of an indwelling urinary catheter. While laser enucleation of the prostate (such as HoLEP, ThuLEP or ThuFLEP) is a safe and effective surgical treatment, it is not well understood how the length of time a patient spent with a urethral catheter before surgery affects the final surgical outcomes. By analyzing patient data from multiple centers of the Minimally Invasive Urology Society, this study aims to evaluate the impact of preoperative catheterization duration on functional outcomes.

Conditions

Urinary Retention; Benign Prostate Obstruction (BPO)

Keywords

Benign Prostatic Obstruction; BPO; BPH; Benign Prostatic Hyperplasia; Bladder Outlet Obstruction; Lower Urinary Tract Symptoms; Acute Urinary Retention; Urinary Catheterization; Catheter Duration; Holmium Laser Enucleation of the Prostate; Thulium Laser Enucleation of the Prostate; HoLEP; ThuLEP; Urology; Prospective Registry; Multicenter Study; ThuFLEP; Thulium Fiber Laser Enucleation of the Prostate

Outcome Measures

Primary Outcomes (3)

• Change in International Prostate Symptom Score (IPSS)

  Evaluation of the improvement in urinary functions after laser enucleation of the prostate (HoLEP, ThuLEP, ThuFLEP): The International Prostate Symptom Score (IPSS) is a validated questionnaire used to assess the severity of urinary symptoms. It consists of 7 questions, each scored from 0 to 5. Total score ranges from 0 to 35. Higher scores indicate more severe urinary symptoms (0-7: mild, 8-19: moderate, 20-35: severe).

  Baseline and 3 months postoperatively

• Change in Peak Urinary Flow Rate (Qmax)

  Evaluation of the improvement in urinary functions after laser enucleation of the prostate (HoLEP, ThuLEP, ThuFLEP): Peak urinary flow rate is measured in milliliters per second (mL/s) using uroflowmetry to assess the improvement in urinary flow after the surgical procedure.

  Baseline and 3 months postoperatively.

• Change in Post-Void Residual Volume (PVR)

  Evaluation of the improvement in urinary functions after laser enucleation of the prostate (HoLEP, ThuLEP, ThuFLEP): Post-void residual volume is the amount of urine remaining in the bladder after voiding, measured in milliliters (mL) via transabdominal ultrasound or catheterization.

  Baseline and 3 months postoperatively.

Secondary Outcomes (1)

• Postoperative Complication Rate

  From the date of surgery up to 3 months postoperatively.

Study Arms (2)

Short-term Catheterization Group

Patients who have been using an indwelling urinary catheter for less than the average of groups prior to the laser enucleation surgery (HoLEP, ThuLEP, ThuFLEP)

Procedure: Laser Enucleation of the Prostate (HoLEP, ThuLEP, ThuFLEP)

Long-term Catheterization Group

Patients who have been using an indwelling urinary catheter for more than the average of groups prior to the laser enucleation surgery (HoLEP, ThuLEP, ThuFLEP)

Procedure: Laser Enucleation of the Prostate (HoLEP, ThuLEP, ThuFLEP)

Interventions

Laser Enucleation of the Prostate (HoLEP, ThuLEP, ThuFLEP) PROCEDURE

Patients undergo endoscopic laser enucleation of the prostate using either Holmium or Thulium laser platforms, depending on the standard equipment and clinical preference of the participating center. The procedure involves the anatomical enucleation of the prostatic adenoma from the surgical capsule, followed by intravesical morcellation of the enucleated tissue. All surgeries are performed by urologists according to established surgical protocols.

Also known as: HoLEP, ThuLEP, Holmium Laser Enucleation of the Prostate, Thulium Laser Enucleation of the Prostate, Laser Prostatectomy, ThuFLEP, Thulium Fiber Laser Enucleation of the Prostate

Long-term Catheterization Group; Short-term Catheterization Group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult male patients presenting to the urology departments of multiple tertiary care hospitals (university and research centers) across Turkey. These patients are characterized by symptomatic benign prostatic obstruction (BPO) and require surgical intervention. Specifically, the population includes individuals who are managed with an indwelling urinary catheter due to urinary retention while awaiting laser enucleation of the prostate (HoLEP, ThuLEP or ThuFLEP).

You may qualify if:

• Patients undergoing laser enucleation of the prostate, including HoLEP, ThuLEP or ThuFLEP procedures, who have an indwelling urinary catheter due to pre-operative urinary retention.

You may not qualify if:

• Patients with a diagnosis of neurogenic bladder or prostate cancer.

Sponsors & Collaborators

• Eskişehir Osmangazi University Medicine Faculty Hospital: lead
• Ankara University: collaborator
• Dokuz Eylul University: collaborator
• Erol Olcok Corum Training and Research Hospital: collaborator
• Gazi University: collaborator
• Marmara University: collaborator
• Samsun Education and Research Hospital: collaborator
• Ondokuz Mayıs University: collaborator
• Cukurova University: collaborator
• Izmir Metropolitan Municipality Esrefpasa Hospital: collaborator
• Tepecik Training and Research Hospital: collaborator

Study Sites (1)

Eskisehir Osmangazi University, Faculty of Medicine, Department of Urology

Eskişehir, Eskişehir, 26040, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Urinary Retention; Prostatic Hyperplasia; Urinary Bladder Neck Obstruction; Lower Urinary Tract Symptoms

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Suleyman Oner, MD

  Eskisehir Osmangazi University Faculty of Medicine Hospital

  STUDY CHAIR

Central Study Contacts

Suleyman Oner, MD

CONTACT

+905544064491; dr.suleymanoner@gmail.com

Cemil Aydin, Professor

CONTACT

+905326960378; cemilaydin78@yahoo.com.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 22, 2026
• Study Start: February 4, 2026
• Primary Completion (Estimated): February 4, 2028
• Study Completion (Estimated): February 4, 2029
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)