- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07603011
Effect of Catheter Duration on Prostate Laser Enucleation Surgery Outcomes in Patients With Urinary Retention
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
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Suleyman Oner, MD
- Phone Number: +905544064491
- Email: dr.suleymanoner@gmail.com
Study Contact Backup
- Name: Cemil Aydin, Professor
- Phone Number: +905326960378
- Email: cemilaydin78@yahoo.com.tr
Study Locations
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Eskişehir
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Eskişehir, Eskişehir, Turkey (Türkiye), 26040
- Recruiting
- Eskisehir Osmangazi University, Faculty of Medicine, Department of Urology
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Contact:
- Suleyman Oner, MD
- Phone Number: +905544064491
- Email: dr.suleymanoner@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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)
|
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:
|
|
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)
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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). |
Baseline and 3 months postoperatively
|
|
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. |
Baseline and 3 months postoperatively.
|
|
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. |
Baseline and 3 months postoperatively.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
From the date of surgery up to 3 months postoperatively.
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Suleyman Oner, MD, Eskisehir Osmangazi University Faculty of Medicine Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Benign Prostatic Hyperplasia
- Lower Urinary Tract Symptoms
- BPH
- Urology
- Multicenter Study
- BPO
- Urinary Catheterization
- HoLEP
- Bladder Outlet Obstruction
- Prospective Registry
- ThuLEP
- ThuFLEP
- Acute Urinary Retention
- Benign Prostatic Obstruction
- Holmium Laser Enucleation of the Prostate
- Thulium Laser Enucleation of the Prostate
- Catheter Duration
- Thulium Fiber Laser Enucleation of the Prostate
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Male
- Prostatic Diseases
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urination Disorders
- Urological Manifestations
- Urinary Bladder Diseases
- Urethral Diseases
- Urethral Obstruction
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Prostatic Hyperplasia
- Lower Urinary Tract Symptoms
- Urinary Retention
- Urinary Bladder Neck Obstruction
- Surgical Procedures, Operative
- Urologic Surgical Procedures
- Urogenital Surgical Procedures
- Urologic Surgical Procedures, Male
- Prostatectomy
- Transurethral Resection of Prostate
Other Study ID Numbers
- E-25403353-050.04-260029122
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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