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Thulium Laser Enucleation With Bladder Neck Incision for Small-Volume Benign Prostatic Hyperplasia (ThuLEP-BNI)

29 aprile 2026 aggiornato da: Qing Yuan, Chinese PLA General Hospital

Thulium Laser Enucleation of the Prostate Combined With Bladder Neck Incision for Small-Volume Benign Prostatic Hyperplasia: A Multicentre, Randomized, Single-Blind, Controlled Trial

This study will evaluate the safety and effectiveness of thulium laser enucleation of the prostate combined with bladder neck incision in men with small-volume benign prostatic hyperplasia (BPH). Small-volume BPH may still cause significant bladder outlet obstruction and bothersome lower urinary tract symptoms, and the optimal surgical treatment for these patients remains uncertain.

In this multicenter, randomized, single-blind, controlled trial, 426 eligible men aged 40 to 80 years will be assigned in a 1:1:1 ratio to one of three groups: thulium laser enucleation of the prostate combined with bladder neck incision, thulium laser enucleation alone, or transurethral resection of the prostate. The main goal is to compare the incidence of bladder neck contracture at 6 months after surgery. Other outcomes include symptom improvement, urinary flow, pain score, sexual function, and safety outcomes during follow-up.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Benign prostatic hyperplasia (BPH) is a common condition in aging men and may lead to bladder outlet obstruction and lower urinary tract symptoms. In some patients, clinically significant obstruction and symptoms can occur even when prostate volume is relatively small. Surgical treatment of small-volume BPH remains challenging because these patients may have an increased risk of postoperative bladder neck contracture, and high-quality evidence for the optimal surgical approach is limited.

This study is a multicenter, randomized, single-blind, parallel-controlled clinical trial designed to evaluate the safety and efficacy of thulium laser enucleation of the prostate combined with bladder neck incision in patients with small-volume BPH. A total of 426 male participants aged 40 to 80 years who meet the eligibility criteria will be enrolled and randomly assigned in a 1:1:1 ratio to one of three treatment groups: (1) thulium laser enucleation of the prostate combined with bladder neck incision, (2) thulium laser enucleation of the prostate alone, or (3) transurethral resection of the prostate.

Small-volume BPH in this study is defined as clinically diagnosed BPH with moderate-to-severe lower urinary tract symptoms or impaired voiding function and a prostate volume of less than 30 mL measured by transrectal ultrasound. The primary endpoint is the incidence of bladder neck contracture at 6 months after surgery. Secondary outcomes include safety outcomes and changes from baseline in International Prostate Symptom Score (IPSS), maximum urinary flow rate (Qmax), Visual Analogue Scale (VAS) score, and IPSS response rate at 3 and 6 months after surgery. Exploratory outcomes include changes in post-void residual urine volume and sexual function assessed by the International Index of Erectile Function-5 (IIEF-5) and the Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD).

Participants will undergo screening, surgical treatment, and postoperative follow-up. Follow-up visits will be conducted at 30 ± 3 days, 90 ± 3 days, and 180 ± 7 days after surgery. Outcome assessments will include symptom scores, uroflowmetry, post-void residual urine volume, adverse events, and cystoscopy at the 180-day visit to assess bladder neck contracture. The results of this trial are expected to provide evidence for an optimized surgical strategy for patients with small-volume BPH.

Tipo di studio

Interventistico

Iscrizione (Stimato)

426

Fase

  • Non applicabile

Contatti e Sedi

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

Contatto studio

Luoghi di studio

  • Cina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Cina, 100039
        • Reclutamento
        • Chinese PLA General Hospital
        • Contatto:

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

Descrizione

Inclusion Criteria:

  • 1. Male patients aged 40-80 years; 2. Diagnosis of benign prostatic hyperplasia and scheduled to undergo surgical treatment; 3. International Prostate Symptom Score of at least 12, maximum urinary flow rate of no more than 15 mL/s, with a voided volume greater than 150 mL; 4. Prostate volume of less than 30 mL measured by transrectal ultrasound, calculated as length × width × height × 0.52; 5. Ability, as assessed by the investigator, to understand the study requirements and complete the scheduled treatment, follow-up visits, and study-related assessments.

Exclusion Criteria:

  • 1. Inability or refusal to provide written informed consent, or inability to comply with the required follow-up schedule; 2. Prostate-specific antigen level of 10 ng/mL or higher, unless prostate cancer has been excluded by biopsy; 3. Confirmed or suspected prostate or bladder malignancy; 4. Pre-existing bladder neck contracture or urethral stricture before surgery; 5. Known coagulation disorder or abnormal coagulation function; 6. Neurogenic bladder or detrusor underactivity that may affect bladder or urethral sphincter function; 7. Benign prostatic hyperplasia complicated by acute urinary tract infection, acute prostatitis, or bacterial prostatitis; 8. History of prostate surgery, urethral stricture, or neurogenic bladder; 9. History of prostate cancer or pelvic radiotherapy; 10. Severe cardiovascular disease, pulmonary disease, or other systemic disease that, in the investigator's judgment, would make the patient unable to tolerate surgery; 11. Participation in another clinical trial related to benign prostatic hyperplasia within 3 months before enrolment; 12. Any other condition that, in the investigator's opinion, makes the patient unsuitable for participation in this study.

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

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: ThuLEP Combined With Bladder Neck Incision
Participants assigned to this arm will undergo thulium laser enucleation of the prostate combined with bladder neck incision. Hyperplastic prostatic tissue will be enucleated along the surgical capsule plane using a thulium fibre laser system. After enucleation and haemostasis, the bladder neck will be assessed intraoperatively, and bladder neck incision will be performed according to protocol-defined anatomical and obstructive findings when considered safe by the operating surgeon.
Procedura: Thulium Laser Enucleation of the Prostate Combined With Bladder Neck Incision
Participants will undergo transurethral thulium laser enucleation of the prostate combined with bladder neck incision. Hyperplastic prostatic tissue will be enucleated along the surgical capsule plane using a thulium fibre laser system. After enucleation and haemostasis, the bladder neck will be assessed intraoperatively, and bladder neck incision will be performed according to protocol-defined anatomical and obstructive findings when considered safe by the operating surgeon.
Comparatore attivo: ThuLEP Alone
Participants assigned to this arm will undergo thulium laser enucleation of the prostate alone. The procedure will be performed transurethrally, and hyperplastic prostatic tissue will be enucleated along the surgical capsule plane using a thulium fibre laser system, followed by haemostasis of the surgical wound.
Procedura: Thulium Laser Enucleation of the Prostate
Participants will undergo transurethral thulium laser enucleation of the prostate alone. Hyperplastic prostatic tissue will be enucleated along the surgical capsule plane using a thulium fibre laser system, followed by haemostasis of the surgical wound. No bladder neck incision will be performed as part of the assigned intervention.
Altri nomi:
  • ThuLEP
Comparatore attivo: Transurethral Resection of the Prostate
Participants assigned to this arm will undergo transurethral resection of the prostate using a conventional resectoscope. Obstructive hyperplastic prostatic tissue will be resected transurethrally according to standard TURP principles to relieve obstruction while avoiding excessive resection and injury to adjacent structures.
Procedura: Transurethral Resection of the Prostate
Participants will undergo transurethral resection of the prostate using a conventional resectoscope. Obstructive hyperplastic prostatic tissue will be resected transurethrally according to standard TURP principles to relieve obstruction while avoiding excessive resection and injury to adjacent structures.
Altri nomi:
  • TURP

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of Bladder Neck Contracture
Lasso di tempo: 6 months after surgery (180 ± 7 days)
Bladder neck contracture will be assessed based on postoperative symptoms, changes in urinary flow, cystoscopic findings, and investigator judgment.
6 months after surgery (180 ± 7 days)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of Postoperative Retrograde Ejaculation
Lasso di tempo: Up to 6 months after surgery
Incidence of postoperative retrograde ejaculation during follow-up.
Up to 6 months after surgery
Incidence of Device-Related New-Onset Severe Urinary Retention
Lasso di tempo: Up to 6 months after surgery
Incidence of device-related new-onset severe urinary retention. Severe urinary retention is defined as urinary retention lasting more than 14 days after postoperative healing.
Up to 6 months after surgery
Incidence of Device-Related New-Onset Stress Urinary Incontinence
Lasso di tempo: Up to 6 months after surgery
Incidence of device-related new-onset stress urinary incontinence during follow-up.
Up to 6 months after surgery
Incidence of Device-Related Bleeding Events Requiring Blood Transfusion
Lasso di tempo: Up to 6 months after surgery
Incidence of device-related bleeding events requiring blood transfusion during follow-up.
Up to 6 months after surgery
Incidence of Device-Related Urethral or Prostatic Capsule Rupture Requiring Surgical Intervention
Lasso di tempo: Up to 6 months after surgery
Incidence of device-related urethral or prostatic capsule rupture requiring surgical intervention during follow-up.
Up to 6 months after surgery
Change From Baseline in International Prostate Symptom Score (IPSS)
Lasso di tempo: 3 months and 6 months after surgery
Change from baseline in International Prostate Symptom Score (IPSS).
3 months and 6 months after surgery
IPSS Response Rate
Lasso di tempo: 3 months and 6 months after surgery
Proportion of participants achieving improvement in IPSS from baseline of at least 30%, 40%, or 50%.
3 months and 6 months after surgery
Change From Baseline in Maximum Urinary Flow Rate (Qmax)
Lasso di tempo: 3 months and 6 months after surgery
Change from baseline in maximum urinary flow rate (Qmax).
3 months and 6 months after surgery
Change From Baseline in Visual Analogue Scale (VAS) Score
Lasso di tempo: 3 months and 6 months after surgery
Change from baseline in Visual Analogue Scale (VAS) score.
3 months and 6 months after surgery

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Post-Void Residual Urine Volume (PVR)
Lasso di tempo: 1 month, 3 months, and 6 months after surgery
Change from baseline in post-void residual urine volume (PVR).
1 month, 3 months, and 6 months after surgery
Change From Baseline in International Index of Erectile Function-5 (IIEF-5)
Lasso di tempo: 1 month, 3 months, and 6 months after surgery
Change from baseline in International Index of Erectile Function-5 (IIEF-5) score.
1 month, 3 months, and 6 months after surgery
Change From Baseline in Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD)
Lasso di tempo: 1 month, 3 months, and 6 months after surgery
Change from baseline in Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD) score.
1 month, 3 months, and 6 months after surgery

Collaboratori e investigatori

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

Sponsor

Chinese PLA General Hospital

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 maggio 2026

Completamento primario (Stimato)

1 giugno 2028

Completamento dello studio (Stimato)

1 giugno 2028

Date di iscrizione allo studio

Primo inviato

29 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 aprile 2026

Primo Inserito (Effettivo)

6 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ThuLEP-BNI-2026-161

Piano per i dati dei singoli partecipanti (IPD)

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

NO

Descrizione del piano IPD

No plan to share individual participant data at this time.

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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