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

8 september 2026 uppdaterad av: Süleyman Öner, Eskişehir Osmangazi University Medicine Faculty Hospital

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

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

54

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Turkiet (Türkiye)
    • Eskişehir
      • Eskişehir, Eskişehir, Turkiet (Türkiye), 26040
        • Rekrytering
        • Eskisehir Osmangazi University, Faculty of Medicine, Department of Urology
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

N/A

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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).

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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)
Procedur: Laser 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.
Andra namn:
  • ThuLEP
  • HoLEP
  • ThuFLEP
  • Holmium Laser Enucleation of the Prostate
  • Thulium Laser Enucleation of the Prostate
  • Laser Prostatectomy
  • Thulium Fiber Laser Enucleation of the Prostate
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)
Procedur: Laser 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.
Andra namn:
  • ThuLEP
  • HoLEP
  • ThuFLEP
  • Holmium Laser Enucleation of the Prostate
  • Thulium Laser Enucleation of the Prostate
  • Laser Prostatectomy
  • Thulium Fiber Laser Enucleation of the Prostate

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in International Prostate Symptom Score (IPSS)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Postoperative Complication Rate
Tidsram: 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.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Eskişehir Osmangazi University Medicine Faculty Hospital

Samarbetspartners

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

Utredare

  • Studiestol: Suleyman Oner, MD, Eskisehir Osmangazi University Faculty of Medicine Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

4 februari 2026

Primärt slutförande (Beräknad)

4 februari 2028

Avslutad studie (Beräknad)

4 februari 2029

Studieregistreringsdatum

Först inskickad

12 maj 2026

Först inskickad som uppfyllde QC-kriterierna

16 maj 2026

Första postat (Faktisk)

22 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

11 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 september 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • E-25403353-050.04-260029122

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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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