Thulium Laser Enucleation With Bladder Neck Incision for Small-Volume Benign Prostatic Hyperplasia (ThuLEP-BNI)
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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 studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Qing Yuan, MD, PhD
- Telefonní číslo: +8618910980422
- E-mail: qyuanmd@outlook.com
Studijní místa
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Čína, 100039
- Nábor
- Chinese PLA General Hospital
-
Kontakt:
- Qing Yuan, MD, PhD
- Telefonní číslo: +8618910980422
- E-mail: qyuanmd@outlook.com
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
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.
|
|
Aktivní komparátor: 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.
|
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.
Ostatní jména:
|
|
Aktivní komparátor: 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.
|
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.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Incidence of Bladder Neck Contracture
Časové okno: 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)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Incidence of Postoperative Retrograde Ejaculation
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 3 months and 6 months after surgery
|
Change from baseline in Visual Analogue Scale (VAS) score.
|
3 months and 6 months after surgery
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change From Baseline in Post-Void Residual Urine Volume (PVR)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- Lee SWH, Chan EMC, Lai YK. The global burden of lower urinary tract symptoms suggestive of benign prostatic hyperplasia: A systematic review and meta-analysis. Sci Rep. 2017 Aug 11;7(1):7984. doi: 10.1038/s41598-017-06628-8.
- Gomes CM, Nunes RV, Araujo RM, Sacomani CR, Trigo-Rocha FE, Bruschini H, Srougi M. Urodynamic evaluation of patients with lower urinary tract symptoms and small prostate volume. Urol Int. 2008;81(2):129-34. doi: 10.1159/000144049. Epub 2008 Aug 29.
- Gravas S, Gacci M, Gratzke C, Herrmann TRW, Karavitakis M, Kyriazis I, Malde S, Mamoulakis C, Rieken M, Sakalis VI, Schouten N, Speakman MJ, Tikkinen KAO, Cornu JN. Summary Paper on the 2023 European Association of Urology Guidelines on the Management of Non-neurogenic Male Lower Urinary Tract Symptoms. Eur Urol. 2023 Aug;84(2):207-222. doi: 10.1016/j.eururo.2023.04.008. Epub 2023 May 17.
- Dias US Jr, de Moura MRL, Viana PCC, de Assis AM, Marcelino ASZ, Moreira AM, Leite CC, Cerri GG, Carnevale FC, Horvat N. Prostatic Artery Embolization: Indications, Preparation, Techniques, Imaging Evaluation, Reporting, and Complications. Radiographics. 2021 Sep-Oct;41(5):1509-1530. doi: 10.1148/rg.2021200144. Epub 2021 Aug 20.
- Lerner LB, McVary KT, Barry MJ, Bixler BR, Dahm P, Das AK, Gandhi MC, Kaplan SA, Kohler TS, Martin L, Parsons JK, Roehrborn CG, Stoffel JT, Welliver C, Wilt TJ. Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA GUIDELINE PART I-Initial Work-up and Medical Management. J Urol. 2021 Oct;206(4):806-817. doi: 10.1097/JU.0000000000002183. Epub 2021 Aug 13. Erratum In: J Urol. 2021 Nov;206(5):1339. doi: 10.1097/JU.0000000000002231.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Urogenitální onemocnění
- Onemocnění genitálií
- Onemocnění pohlavních orgánů, muž
- Onemocnění prostaty
- Mužská urogenitální onemocnění
- Urologická onemocnění
- Ženské urogenitální onemocnění
- Ženské urogenitální onemocnění a těhotenské komplikace
- Urologické projevy
- Onemocnění močového měchýře
- Uretrální onemocnění
- Uretrální obstrukce
- Patologické stavy, příznaky a symptomy
- Příznaky a symptomy
- Hyperplazie prostaty
- Příznaky dolních močových cest
- Obstrukce krku močového měchýře
- Chirurgické postupy, operativní
- Urologické chirurgické zákroky
- Urogenitální chirurgické zákroky
- Urologické chirurgické zákroky, muž
- Prostatektomie
- Transuretrální resekce prostaty
Další identifikační čísla studie
- ThuLEP-BNI-2026-161
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .