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Selective Median Lobe Surgery Outcomes Study (UNVEIL-BPO)

9. července 2026 aktualizováno: Selim Soyturk, Necmettin Erbakan University

UNVEIL-BPO Median Lobe Study: An International Multicenter Evaluation of Selective Median Lobe Resection and Enucleation

This prospective multicenter observational cohort study will evaluate clinical outcomes after selective median lobe transurethral surgery for benign prostatic obstruction. Eligible men with lower urinary tract symptoms or urinary retention who are scheduled for selective median lobe-only TURP, HoLEP, or anatomical endoscopic enucleation as part of routine clinical care will be enrolled and followed after surgery.

The study will collect preoperative clinical data, symptom scores, uroflowmetry, postvoid residual volume, prostate volume, intravesical prostatic protrusion measurements, cystoscopic anatomical findings, intraoperative variables, and postoperative outcomes. The primary outcome is composite clinical failure at 12 months.

The main aim is to identify practical preoperative urology-based anatomical and functional predictors of clinical failure after selective median lobe surgery and to develop an exploratory prediction model that may help improve patient selection in future practice.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

Selective median lobe transurethral surgery is used in selected men with benign prostatic obstruction in whom the median lobe or high bladder neck median component is considered the dominant obstructive anatomy. This approach may provide urinary improvement while potentially reducing ejaculatory dysfunction compared with complete transurethral prostate surgery. However, some patients may experience persistent or recurrent symptoms because of residual lateral lobe obstruction, unfavorable bladder neck anatomy, insufficient functional improvement, or bladder dysfunction.

This study is designed as a prospective multicenter observational cohort. The surgical decision and the choice of technique will not be assigned by the study protocol. Patients will undergo selective median lobe TURP, selective median lobe HoLEP, or selective median lobe anatomical endoscopic enucleation according to the treating surgeon's routine clinical judgment.

The study will evaluate whether preoperative urology-based variables can predict 12-month clinical failure. Candidate predictors include intravesical prostatic protrusion length or grade, cystoscopic median lobe morphology, lateral lobe obstruction score, bladder neck configuration, baseline symptom burden, storage symptom burden, uroflowmetry pattern, Qmax, and postvoid residual volume. Intraoperative variables, including procedure type, energy platform, extent of lateral lobe treatment, bladder neck management, operative time, tissue weight, catheter duration, and complications will also be recorded.

The primary endpoint is 12-month composite clinical failure, defined by inadequate symptom improvement, inadequate functional improvement, persistent voiding failure, restart of BPH-related medication, recurrent urinary retention or need for recatheterization after the early postoperative period, need for reintervention, or patient-reported global failure due to insufficient urinary benefit.

Secondary outcomes include changes in IPSS, quality of life, uroflowmetry parameters, postvoid residual volume, durability of response, medication-free survival, reintervention-free survival, preservation of antegrade ejaculation, de novo ejaculatory dysfunction, urinary incontinence, urethral stricture, bladder neck contracture, and Clavien-Dindo complications.

The study will also explore the performance of a practical urology-based Median Lobe Failure Index. This index will be evaluated as an exploratory tool only and will not be used to guide clinical decision-making during the study.

Typ studie

Pozorovací

Zápis (Odhadovaný)

420

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Turecko (Türkiye)
    • Edremit
      • Van, Edremit, Turecko (Türkiye), 65140
        • University of Health Sciences Türkiye, Van Training and Research Hospital
        • Kontakt:
    • Konya
      • Konya, Konya, Turecko (Türkiye), 42090
        • Necmettin Erbakan University, Meram Faculty of Medicine
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Selcuk Guven, MD, Professor

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

Men aged 45 years or older with moderate-to-severe lower urinary tract symptoms or urinary retention attributed to benign prostatic obstruction, in whom preoperative evaluation suggests median lobe-dominant or median lobe-related obstruction and who are scheduled to undergo selective median lobe transurethral surgery as part of routine clinical care at participating centers.

Popis

Inclusion Criteria:

  • Male patients aged 45 years or older.

    • Moderate-to-severe lower urinary tract symptoms due to benign prostatic obstruction or urinary retention requiring transurethral surgery.
    • Preoperative findings suggesting median lobe-dominant or median lobe-related obstruction.
    • Planned selective median lobe-only TURP, HoLEP, or anatomical endoscopic enucleation as part of routine clinical care.
    • Available baseline International Prostate Symptom Score, uroflowmetry and/or postvoid residual volume, prostate volume, intravesical prostatic protrusion measurement, and cystoscopic assessment.
    • Ability to provide written informed consent and comply with the follow-up schedule.

Exclusion Criteria:

  • Previous prostate surgery for benign prostatic hyperplasia.
  • Known urethral stricture requiring treatment before or during the index procedure.
  • Known neurogenic lower urinary tract dysfunction.
  • Active prostate cancer or bladder cancer requiring treatment that may confound urinary outcomes.
  • Planned complete TURP, complete HoLEP/AEEP, or lateral lobe-dominant surgery.
  • Severe kissing lateral lobe obstruction considered to require complete surgery rather than selective median lobe surgery.
  • Inability to provide valid baseline or follow-up outcome data.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
Selective Median Lobe TURP
Men undergoing selective transurethral resection of the median lobe for benign prostatic obstruction as part of routine clinical care, without planned complete lateral lobe resection.
Postup: Selective Median Lobe TURP
Selective transurethral resection of the median lobe or median component of the bladder outlet. The procedure is performed according to the treating surgeon's routine clinical practice and is not assigned by the study protocol.
Ostatní jména:
  • MLO-TURP
  • Median lobe-only TURP
Selective Median Lobe HoLEP/AEEP
Men undergoing selective median lobe holmium laser enucleation or another anatomical endoscopic enucleation technique for benign prostatic obstruction as part of routine clinical care, without planned complete gland enucleation.
Postup: Selective Median Lobe HoLEP/AEEP
Selective enucleation of the median lobe or median component of the bladder outlet using HoLEP or another anatomical endoscopic enucleation platform. The procedure is performed according to the treating surgeon's routine clinical practice and is not assigned by the study protocol.
Ostatní jména:
  • ML-HoLEP
  • Selective median lobe HoLEP
  • Selective median lobe anatomical endoscopic enucleation

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Proportion of Participants With Composite Clinical Failure at 12 Months
Časové okno: 12 months after surgery
Composite clinical failure is defined as the presence of at least one of the following within 12 months or at the 12-month assessment: inadequate symptom improvement, inadequate functional improvement, persistent voiding failure, restart of BPH-related medication due to recurrent or persistent voiding symptoms, recurrent urinary retention or need for recatheterization after the early postoperative period, need for reintervention, or patient-reported global failure due to insufficient urinary benefit.
12 months after surgery

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in International Prostate Symptom Score Total Score
Časové okno: Baseline, 3 months, 6 months, 12 months, and 24 months after surgery
Change in International Prostate Symptom Score total score from baseline to postoperative follow-up visits. Higher scores indicate more severe lower urinary tract symptoms.
Baseline, 3 months, 6 months, 12 months, and 24 months after surgery
Change in International Prostate Symptom Score Voiding Subscore
Časové okno: Baseline, 3 months, 6 months, 12 months, and 24 months after surgery
Change in International Prostate Symptom Score voiding subscore from baseline to postoperative follow-up visits.Higher scores indicate more severe lower urinary tract symptoms
Baseline, 3 months, 6 months, 12 months, and 24 months after surgery
Change in International Prostate Symptom Score Storage Subscore
Časové okno: Baseline, 3 months, 6 months, 12 months, and 24 months after surgery
Change in International Prostate Symptom Score storage subscore from baseline to postoperative follow-up visits.Higher scores indicate more severe lower urinary tract symptoms
Baseline, 3 months, 6 months, 12 months, and 24 months after surgery
Change in International Prostate Symptom Score Quality of Life Score
Časové okno: Baseline, 3 months, 6 months, 12 months, and 24 months after surgery
Change in International Prostate Symptom Score quality of life score from baseline to postoperative follow-up visits. Higher scores indicate worse disease-specific quality of life.
Baseline, 3 months, 6 months, 12 months, and 24 months after surgery
Change in Maximum Urinary Flow Rate
Časové okno: Baseline, 3 months, 12 months, and 24 months after surgery
Change in maximum urinary flow rate measured by uroflowmetry from baseline to postoperative follow-up visits.
Baseline, 3 months, 12 months, and 24 months after surgery
Change in Postvoid Residual Volume
Časové okno: Baseline, 3 months, 12 months, and 24 months after surgery
Change in postvoid residual urine volume from baseline to postoperative follow-up visits.
Baseline, 3 months, 12 months, and 24 months after surgery
Proportion of Participants Restarting BPH-Related Medication
Časové okno: Up to 24 months after surgery
Proportion of participants who restart medication for benign prostatic hyperplasia or lower urinary tract symptoms after the early postoperative period because of persistent or recurrent symptoms.
Up to 24 months after surgery
Proportion of Participants Requiring BPH-Related Reintervention
Časové okno: Up to 24 months after surgery
Proportion of participants requiring additional intervention for benign prostatic obstruction, including bladder neck incision, repeat TURP, repeat HoLEP or AEEP, lateral lobe surgery, or another BPH-related surgical procedure.
Up to 24 months after surgery
Proportion of Participants With Preserved Antegrade Ejaculation
Časové okno: 3 months, 12 months, and 24 months after surgery
Proportion of Participants With Preserved Antegrade Ejaculation
3 months, 12 months, and 24 months after surgery
Proportion of Participants With De Novo Ejaculatory Dysfunction
Časové okno: 3 months, 12 months, and 24 months after surgery
Proportion of participants reporting new ejaculatory dysfunction after surgery among those without ejaculatory dysfunction at baseline.
3 months, 12 months, and 24 months after surgery
Proportion of Participants With Postoperative Adverse Events or Late Anatomical Complications
Časové okno: Up to 24 months after surgery
Proportion of participants with postoperative adverse events or late anatomical complications, including urinary incontinence, urethral stricture, bladder neck contracture, urinary tract infection, urinary retention, bleeding, or other complications classified according to the Clavien-Dindo system when applicable.
Up to 24 months after surgery

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Performance of the Exploratory Urology-Based Median Lobe Failure Index
Časové okno: 12 months after surgery
Exploratory evaluation of the Urology-Based Median Lobe Failure Index for predicting 12-month composite clinical failure. Model performance will be assessed using discrimination, calibration, and overall predictive performance measures. The index will not be used for clinical decision-making during the study.
12 months after surgery

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Necmettin Erbakan University

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. září 2026

Primární dokončení (Odhadovaný)

1. prosince 2028

Dokončení studie (Odhadovaný)

1. prosince 2030

Termíny zápisu do studia

První předloženo

4. července 2026

První předloženo, které splnilo kritéria kontroly kvality

9. července 2026

První zveřejněno (Aktuální)

13. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

13. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

9. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • UNVEIL-BPO-ML-001

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NEROZHODNÝ

Popis plánu IPD

De-identified individual participant data underlying the published results may be made available upon reasonable request after publication, subject to approval by the study steering committee and applicable ethics, institutional, and data protection regulations.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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