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

8. september 2026 oppdatert 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

54

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Tyrkia (Türkiye)
    • Eskişehir
      • Eskişehir, Eskişehir, Tyrkia (Türkiye), 26040
        • Rekruttering
        • Eskisehir Osmangazi University, Faculty of Medicine, Department of Urology
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

N/A

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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).

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / 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)
Fremgangsmåte: 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.
Andre navn:
  • 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)
Fremgangsmåte: 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.
Andre navn:
  • ThuLEP
  • HoLEP
  • ThuFLEP
  • Holmium Laser Enucleation of the Prostate
  • Thulium Laser Enucleation of the Prostate
  • Laser Prostatectomy
  • Thulium Fiber Laser Enucleation of the Prostate

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in International Prostate Symptom Score (IPSS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Postoperative Complication Rate
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Eskişehir Osmangazi University Medicine Faculty Hospital

Samarbeidspartnere

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

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

4. februar 2026

Primær fullføring (Antatt)

4. februar 2028

Studiet fullført (Antatt)

4. februar 2029

Datoer for studieregistrering

Først innsendt

12. mai 2026

Først innsendt som oppfylte QC-kriteriene

16. mai 2026

Først lagt ut (Faktiske)

22. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. september 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • E-25403353-050.04-260029122

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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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