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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorEskişehir Osmangazi University Medicine Faculty Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients with a diagnosis of neurogenic bladder or prostate cancer.

Trial 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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

    Procedure/Surgery

    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.

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: Short-term Catheterization Group1 intervention
Group B: Long-term Catheterization Group1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Baseline and 3 months postoperatively
2

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.

Time frame
Baseline and 3 months postoperatively.
3

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.

Time frame
Baseline and 3 months postoperatively.

Secondary outcomes

1

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eskişehir Osmangazi University Medicine Faculty Hospital

Lead sponsor

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