Benign Prostate Obstruction (BPO), Urinary Retention
Conditions
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
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.
Detailed description
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.
Interventions
PROCEDURELaser Enucleation of the Prostate (HoLEP, ThuLEP, ThuFLEP)
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.
Sponsors
Eskişehir Osmangazi University Medicine Faculty Hospital
Ankara University
Dokuz Eylul University
Erol Olcok Corum Training and Research Hospital
Gazi University
Marmara University
Samsun Education and Research Hospital
Ondokuz Mayıs University
Cukurova University
Izmir Metropolitan Municipality Esrefpasa Hospital
Tepecik Training and Research Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in International Prostate Symptom Score (IPSS) | 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). |
| Change in Peak Urinary Flow Rate (Qmax) | 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. |
| Change in Post-Void Residual Volume (PVR) | 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Complication Rate | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTSuleyman Oner, MD
CONTACTCemil Aydin, Professor
STUDY_CHAIRSuleyman Oner, MD
Eskisehir Osmangazi University Faculty of Medicine Hospital
Outcome results
None listed