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NCT Number: NCT07603011

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

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.

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Key information

Conditions

Urinary Retention Benign Prostate Obstruction (BPO) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Urethral Diseases Urethral Obstruction Urinary Bladder Diseases Urinary Bladder Neck Obstruction Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Eskisehir Osmangazi University, Faculty of Medicine, Department of Urology

Eskişehir, 26040, Turkey (Türkiye)

Location status: Recruiting

Location contact

Suleyman Oner, MD

CONTACT

[email protected]

+905544064491

About this study

This study is designed as a prospective, observational, multicenter, cohort study conducted under the academic coordination of the Minimally Invasive Urology Society. The study will analyze data from multiple participating centers across Turkey. All clinical parameters will be standardized and recorded in a secure, electronic environment. Preoperative data include patient demographics, catheter duration and baseline urinary scores. Intraoperative data focus on surgical duration and energy parameters. Postoperative data track recovery, complication rates according to the Clavien-Dindo classifications and functional outcomes like flow rates (Qmax), International Prostate Symptom Score (IPSS), post-void residual volume (PVR) at 3 months.

By integrating data from diverse clinical settings, this multicenter study aims to establish a clearer understanding of the optimal timing of surgery, ultimately improving clinical decision-making for patients with urinary retention.

Who can participate

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

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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.

Other names: HoLEP, ThuLEP, Holmium Laser Enucleation of the Prostate, Thulium Laser Enucleation of the Prostate, Laser Prostatectomy, ThuFLEP, Thulium Fiber Laser Enucleation of the Prostate

Primary outcomes

  1. Change in International Prostate Symptom Score (IPSS)

    Time frame: Baseline and 3 months postoperatively

    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).

  2. Change in Peak Urinary Flow Rate (Qmax)

    Time frame: Baseline and 3 months postoperatively.

    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.

  3. Change in Post-Void Residual Volume (PVR)

    Time frame: Baseline and 3 months postoperatively.

    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.

Secondary outcomes

  1. Postoperative Complication Rate

    Time frame: From the date of surgery up to 3 months postoperatively.

    The frequency and severity of surgical complications occurring after laser enucleation of the prostate (HoLEP, ThuLEP, ThuFLEP). Complications will be categorized and graded using the Clavien-Dindo Classification of Surgical Complications. This scale ranges from Grade I (minor deviations from the normal postoperative course) to Grade V (death of the patient). Higher grades indicate a worse outcome (more severe complications).

    Grade I: Any deviation from the normal postoperative course without the need for treatment.

    Grade II: Complications requiring pharmacological treatment Grade III: Complications requiring surgical, endoscopic, or radiological intervention Grade IV: Life-threatening complications requiring intensive care unit (ICU) management Grade V: Death of the patient.

Study contacts

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

Cemil Aydin, Professor

CONTACT

[email protected]

+905326960378

Suleyman Oner, MD

CONTACT

[email protected]

+905544064491

Sponsors and collaborators

Lead sponsor

Eskişehir Osmangazi University Medicine Faculty Hospital

Other

Collaborators

  • Ankara University
  • Cukurova University
  • Dokuz Eylul University
  • Erol Olcok Corum Training and Research Hospital
  • Gazi University
  • Izmir Metropolitan Municipality Esrefpasa Hospital
  • Marmara University
  • Ondokuz Mayıs University
  • Samsun Education and Research Hospital
  • Tepecik Training and Research Hospital

Registry information

Official study title

Evaluation of the Effect of Catheter Duration on Prostate Laser Enucleation Surgery Outcomes in Patients With Indwelling Catheters Due to Urinary Retention: A Multicenter Study of the Minimally Invasive Urology Society

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
May 22, 2026
Registry last updated
May 22, 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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