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Selective Median Lobe Surgery Outcomes Study (UNVEIL-BPO)

9 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

420

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Turchia (Türkiye)
    • Edremit
      • Van, Edremit, Turchia (Türkiye), 65140
        • University of Health Sciences Türkiye, Van Training and Research Hospital
        • Contatto:
    • Konya
      • Konya, Konya, Turchia (Türkiye), 42090
        • Necmettin Erbakan University, Meram Faculty of Medicine
        • Contatto:
        • Investigatore principale:
          • Selcuk Guven, MD, Professor

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Procedura: 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.
Altri nomi:
  • 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.
Procedura: 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.
Altri nomi:
  • ML-HoLEP
  • Selective median lobe HoLEP
  • Selective median lobe anatomical endoscopic enucleation

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of Participants With Composite Clinical Failure at 12 Months
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in International Prostate Symptom Score Total Score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Performance of the Exploratory Urology-Based Median Lobe Failure Index
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Necmettin Erbakan University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 dicembre 2028

Completamento dello studio (Stimato)

1 dicembre 2030

Date di iscrizione allo studio

Primo inviato

4 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

9 luglio 2026

Primo Inserito (Effettivo)

13 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • UNVEIL-BPO-ML-001

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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