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| Name | Class |
|---|---|
| Ankara University | OTHER |
| Dokuz Eylul University | OTHER |
| Erol Olcok Corum Training and Research Hospital | OTHER |
| Gazi University |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Complication Rate | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suleyman Oner, MD | Contact | +905544064491 | dr.suleymanoner@gmail.com | |
| Cemil Aydin, Professor | Contact | +905326960378 | cemilaydin78@yahoo.com.tr |
| Name | Affiliation | Role |
|---|---|---|
| Suleyman Oner, MD | Eskisehir Osmangazi University Faculty of Medicine Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eskisehir Osmangazi University, Faculty of Medicine, Department of Urology | Recruiting | Eskişehir | Eskişehir | 26040 | Turkey (Türkiye) |
Individual participant data (IPD) will not be shared due to privacy concerns and data protection regulations, including the Turkish Personal Data Protection Law (KVKK). Only aggregated, de-identified results will be reported in publications and presentations.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 3, 2026 |
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| OTHER |
| Marmara University | OTHER |
| Samsun Education and Research Hospital | OTHER |
| Ondokuz Mayıs University | OTHER |
| Cukurova University | OTHER |
| Izmir Metropolitan Municipality Esrefpasa Hospital | OTHER |
| Tepecik Training and Research Hospital | OTHER |
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| From the date of surgery up to 3 months postoperatively. |
| May 12, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 3, 2026 | May 12, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D016055 | Urinary Retention |
| D011470 | Prostatic Hyperplasia |
| D001748 | Urinary Bladder Neck Obstruction |
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D014524 | Urethral Obstruction |
| D014522 | Urethral Diseases |
| D001745 | Urinary Bladder Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D020728 | Transurethral Resection of Prostate |
| ID | Term |
|---|---|
| D011468 | Prostatectomy |
| D013521 | Urologic Surgical Procedures, Male |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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