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A Prospective Comparative Study Evaluating the Safety and Efficacy of Transurethral Thulium Fiber Laser, Holmium Laser and Bipolar Enucleation of Large Sized Prostate

3 juni 2026 uppdaterad av: Abdullah Salah Al Debeiky, Tanta University
This study compares the safety and efficacy of three endoscopic enucleation techniques for large prostates (>100 mL) in patients with benign prostatic hyperplasia (BPH): Thulium Fiber Laser Enucleation (ThuFLEP), Holmium Laser Enucleation (HoLEP), and Bipolar Enucleation (B-TUEP). Ninety male patients with severe lower urinary tract symptoms (IPSS ≥20, Qmax ≤10 mL/s) who failed medical therapy will be randomized 1:1:1 into three groups of 30. Primary outcomes include IPSS, quality of life score, maximum flow rate (Qmax), and post-void residual at 1, 3, and 6 months postoperatively. Secondary outcomes include operative time, enucleation efficiency, blood loss, catheterization duration, hospital stay, and complication rates assessed by the Clavien-Dindo classification.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Benign prostatic hyperplasia (BPH) is a progressive condition causing lower urinary tract symptoms (LUTS) that significantly impairs quality of life in aging men. While medical therapy with alpha-blockers and 5-alpha reductase inhibitors represents first-line management, surgical intervention becomes necessary when symptoms are severe or complications arise.

Anatomical endoscopic enucleation of the prostate has emerged as the size-independent gold standard surgical approach. This prospective randomized controlled trial will be conducted at the Urology Department, Tanta University Hospital (October 2025 - October 2027) following IRB approval (Code: 36265MD479/10/25).

Patients will undergo preoperative evaluation including IPSS, QoL index, IIEF-5, uroflowmetry, transrectal ultrasound, PSA, CBC, coagulation profile, and renal/liver function tests. Intraoperative data will include total operative time, enucleation time, morcellation time, enucleation efficiency (g/min), and estimated blood loss. Postoperative follow-up at 1, 3, and 6 months will assess IPSS, QoL, IIEF-5, Qmax, and post-void residual. Complications will be graded using the Clavien-Dindo classification. Randomization will use the sealed opaque envelope method with 1:1:1 allocation.

Studietyp

Interventionell

Inskrivning (Beräknad)

90

Fas

  • Inte tillämpbar

Kontakter och platser

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

Studiekontakt

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Studieorter

  • Egypten
    • Gharbia Governorate
      • Tanta, Gharbia Governorate, Egypten, 31111
        • Rekrytering
        • Tanta University Hospital
        • Kontakt:
        • Kontakt:
        • Huvudutredare:
          • Omar Khaled Gad, MSc
        • Underutredare:
          • Hassan Hussein El-Tatawy, MD
        • Underutredare:
          • Mohamed Hassan Radwan, MD
        • Underutredare:
          • Mohamed Osama Abou Farha, MD
        • Underutredare:
          • Abdullah Salah Al Debeiky, MD

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

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Beskrivning

Inclusion Criteria:

  • Male patients diagnosed with BPH
  • Clinical diagnosis of BPH with lower urinary tract symptoms.
  • IPSS ≥ 20 (severe symptoms)
  • Maximum urinary flow rate (Qmax) ≤ 10 mL/s
  • Prostate volume >100 mL (measured by transrectal ultrasound)
  • Failed medical therapy and fit for operation

Exclusion Criteria:

  • Prostate cancer (current or history).
  • Previous prostate surgery
  • Previous urethral surgery.
  • Neurogenic bladder dysfunction.
  • Active urinary tract infection.
  • Severe cardiovascular disease (ASA Class IV).
  • Previous pelvic radiation.
  • Urethral stricture
  • Urinary bladder stones.

Studieplan

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

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: ThuFLEP Group
30 patients undergoing Thulium Fiber Laser Enucleation of the Prostate using Quanta 60W with 550nm Thulium fiber
Procedur: Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP)
Anatomical endoscopic enucleation of the prostate performed transurethrally using a Quanta thulium fiber laser at 60 watts with a 550 μm thulium fiber. Enucleated tissue was removed using a morcellator.
Aktiv komparator: HoLEP Group
30 patients undergoing Holmium Laser Enucleation of the Prostate using Quanta 150W with 550nm Holmium YAG fiber
Procedur: Holmium Laser Enucleation of the Prostate (HoLEP)
Anatomical endoscopic enucleation of the prostate performed transurethrally using a Quanta holmium YAG laser at 150 watts with a 550 μm holmium fiber. Enucleated tissue was removed using a morcellator.
Aktiv komparator: Bipolar Enucleation Group
30 patients undergoing Bipolar Transurethral Enucleation of the Prostate using standard bipolar energy
Procedur: Bipolar Transurethral Enucleation of the Prostate (B-TUEP)
Anatomical endoscopic enucleation of the prostate performed transurethrally using standard bipolar electrical energy. Enucleated tissue was removed using a morcellator.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
International Prostate Symptom Score (IPSS)
Tidsram: at 1, 3 and 6 months post-surgery
Change from baseline in IPSS total score (0-35 scale; higher scores indicate worse urinary symptoms). Scores compared across ThuFLEP, HoLEP, and bipolar enucleation groups.
at 1, 3 and 6 months post-surgery
Quality of Life Score (QoL)
Tidsram: Baseline and at 1, 3, and 6 months post-surgery
Change from baseline in the IPSS-linked Quality of Life index (0-6 scale; higher scores indicate worse quality of life due to urinary symptoms).
Baseline and at 1, 3, and 6 months post-surgery
Maximum Urinary Flow Rate (Qmax)
Tidsram: Baseline and at 1, 3, and 6 months post-surgery
Change from baseline in maximum urinary flow rate in mL/s as measured by uroflowmetry. Higher values indicate better voiding function.
Baseline and at 1, 3, and 6 months post-surgery
Post-Void Residual Urine Volume (PVR)
Tidsram: Baseline and at 1, 3, and 6 months post-surgery
Change from baseline in post-void residual urine volume in mL as measured by transabdominal ultrasound. Lower values indicate better bladder emptying.
Baseline and at 1, 3, and 6 months post-surgery

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Total Operative Time in Minutes
Tidsram: Intraoperative
Total surgical time from start of procedure to completion, including enucleation and morcellation phases.
Intraoperative
Enucleation Efficiency in Grams per Minute
Tidsram: Intraoperative
Weight of enucleated prostatic tissue (grams) divided by enucleation time (minutes), reflecting surgical speed and effectiveness.
Intraoperative
Estimated Blood Loss as Change in Hemoglobin Level
Tidsram: Baseline and 24 hours postoperatively
Difference between preoperative and 24-hour postoperative serum hemoglobin levels (g/dL). Greater decrease indicates more blood loss.
Baseline and 24 hours postoperatively
Catheterization Duration in Days
Tidsram: Up to 7 days postoperatively
Number of days from end of surgery until urethral catheter removal, based on resolution of hematuria and clinical assessment.
Up to 7 days postoperatively
Length of Hospital Stay in Days
Tidsram: Up to 7 days postoperatively
Total number of days from surgery to hospital discharge.
Up to 7 days postoperatively
Number of Participants with Postoperative Complications as Assessed by Clavien-Dindo Classification
Tidsram: Up to 6 months postoperatively
Rate and severity of complications including urinary incontinence, urinary tract infection, urethral stricture, and need for reoperation, graded using the Clavien-Dindo classification system (Grade I-V; higher grade indicates more severe complication).
Up to 6 months postoperatively
Erectile Function Score (IIEF-5)
Tidsram: Baseline and at 1, 3, and 6 months postoperatively
Change from baseline in International Index of Erectile Function-5 (IIEF-5) questionnaire score (range 5-25; higher scores indicate better erectile function).
Baseline and at 1, 3, and 6 months postoperatively

Samarbetspartners och utredare

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

Sponsor

Tanta University

Utredare

  • Studierektor: Hassan Hussein El-Tatawy, MD, Tanta University Faculty of Medicine

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

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)

21 oktober 2025

Primärt slutförande (Beräknad)

30 november 2026

Avslutad studie (Beräknad)

30 maj 2027

Studieregistreringsdatum

Först inskickad

26 maj 2026

Först inskickad som uppfyllde QC-kriterierna

29 maj 2026

Första postat (Faktisk)

4 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 juni 2026

Senast verifierad

1 oktober 2025

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 36265MD479/10/25

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

Individual participant data underlying published results will be shared after de-identification, including data for primary and secondary outcome measures. Data will be available upon reasonable request to the corresponding author following publication.

Tidsram för IPD-delning

Beginning 6 months after publication of primary results

Kriterier för IPD Sharing Access

Researchers who provide a methodologically sound proposal approved by the study team. Requests should be directed to the corresponding author. Data will be shared for individual participant meta-analyses or systematic reviews.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • ICF

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