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

29 kwietnia 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

426

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Chiny
    • Beijing Municipality
      • Beijing, Beijing Municipality, Chiny, 100039
        • Rekrutacyjny
        • Chinese PLA General Hospital
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Aktywny komparator: 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.
Inne nazwy:
  • ThuLEP
Aktywny komparator: 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.
Inne nazwy:
  • TURP

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Incidence of Bladder Neck Contracture
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Incidence of Postoperative Retrograde Ejaculation
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 3 months and 6 months after surgery
Change from baseline in Visual Analogue Scale (VAS) score.
3 months and 6 months after surgery

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline in Post-Void Residual Urine Volume (PVR)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Chinese PLA General Hospital

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 maja 2026

Zakończenie podstawowe (Szacowany)

1 czerwca 2028

Ukończenie studiów (Szacowany)

1 czerwca 2028

Daty rejestracji na studia

Pierwszy przesłany

29 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

29 kwietnia 2026

Pierwszy wysłany (Rzeczywisty)

6 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

6 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

29 kwietnia 2026

Ostatnia weryfikacja

1 kwietnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • ThuLEP-BNI-2026-161

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

No plan to share individual participant data at this time.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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