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

18 juli 2026 bijgewerkt door: 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, Four-Arm Controlled Trial

This study will evaluate the safety and effectiveness of different surgical treatments for men with small-volume benign prostatic hyperplasia (BPH). Men with small-volume BPH may still have bothersome lower urinary tract symptoms and bladder outlet obstruction, and the best surgical treatment for this group remains uncertain.

In this multicentre, randomized, single-blind, four-arm controlled trial, 932 eligible men aged 40 to 80 years will be assigned in a 1:1:1:1 ratio to one of four groups: thulium laser enucleation of the prostate combined with bladder neck incision, thulium laser enucleation of the prostate alone, transurethral resection of the prostate (TURP), or transurethral incision of the prostate (TUIP).

The main goal of the study is to compare the incidence of bladder neck contracture at 6 months after surgery. Secondary outcomes include safety outcomes and changes in urinary symptoms, urinary flow rate, pain score, and symptom response at 3 and 6 months after surgery. Exploratory outcomes include changes in post-void residual urine volume and sexual function scores. Additional exploratory long-term outcomes will also be assessed at 12 months after surgery.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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. Small-volume BPH should not necessarily be regarded as a mild condition, because these patients may still experience bothersome symptoms, impaired urinary flow, increased post-void residual urine volume, and bladder outlet obstruction. In this subgroup, obstruction may be related not only to adenomatous enlargement, but also to an elevated, narrow, or fibrotic bladder neck. Surgical treatment of small-volume BPH remains challenging, and the optimal surgical approach has not been clearly established.

This study is a multicentre, randomized, single-blind, four-arm controlled clinical trial designed to evaluate the safety and efficacy of different surgical strategies for patients with small-volume BPH. Eligible male participants aged 40 to 80 years with a prostate volume of less than 30 mL and clinically significant lower urinary tract symptoms or impaired voiding function will be enrolled. A total of 932 participants will be randomly assigned in a 1:1:1:1 ratio to one of four treatment groups: thulium laser enucleation of the prostate combined with bladder neck incision, thulium laser enucleation of the prostate alone, transurethral resection of the prostate (TURP), or transurethral incision of the prostate (TUIP).

The primary objective of the study is to compare the incidence of bladder neck contracture at 6 months after surgery among the treatment groups. Secondary outcomes include safety outcomes and changes 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 scores, including the International Index of Erectile Function-5 (IIEF-5) and the Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD). Additional exploratory long-term outcomes will be assessed at 12 months after surgery, including delayed bladder neck contracture, maintenance of urinary function, late adverse events, and the need for reintervention.

The study is designed to provide high-quality evidence on the comparative safety and effectiveness of these four surgical approaches in men with small-volume BPH and to help define an optimal surgical strategy for this specific patient population.

Studietype

Ingrijpend

Inschrijving (Geschat)

932

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100039
        • Chinese PLA General Hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • Male patients aged 40-80 years.
  • Diagnosis of benign prostatic hyperplasia (BPH) and scheduled to undergo surgical treatment.
  • International Prostate Symptom Score (IPSS) of at least 12, maximum urinary flow rate of no more than 15 mL/s, with a voided volume greater than 150 mL.
  • Prostate volume of less than 30 mL measured by transrectal ultrasound (TRUS), calculated as length × width × height × 0.52.
  • 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:

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Procedure: 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.
Actieve vergelijker: 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.
Procedure: 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.
Andere namen:
  • DoLEP
Actieve vergelijker: 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.
Procedure: 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.
Andere namen:
  • TURP
Actieve vergelijker: Transurethral Incision of the Prostate (TUIP)
Participants assigned to this arm will undergo transurethral incision of the prostate (TUIP) using standard endoscopic equipment. After endoscopic inspection of the urethra, prostatic urethra, bladder neck, and bladder, one or two longitudinal incisions will be made at the bladder neck and prostatic urethra according to prostate morphology and the degree of obstruction. The procedure aims to relieve bladder outlet obstruction without substantial prostatic tissue resection. The incision site and extent will be individualized based on intraoperative anatomy, with careful avoidance of injury to the ureteric orifices, urethral sphincter, and adjacent structures. Haemostasis will be performed when necessary.
Procedure: Transurethral Incision of the Prostate
Participants assigned to this intervention will undergo transurethral incision of the prostate using standard endoscopic equipment. One or two longitudinal incisions will be made at the bladder neck and prostatic urethra according to prostate morphology and the degree of obstruction. The procedure aims to relieve bladder outlet obstruction without substantial prostatic tissue resection. The incision site and extent will be individualized according to intraoperative anatomy, with careful avoidance of injury to the ureteric orifices, urethral sphincter, and adjacent structures. Haemostasis will be performed when necessary.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of Bladder Neck Contracture
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of Postoperative Retrograde Ejaculation
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
IPSS Response Rate
Tijdsspanne: 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)
Tijdsspanne: 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 International Prostate Symptom Score (IPSS)
Tijdsspanne: 3 months and 6 months after surgery
Change from baseline in International Prostate Symptom Score (IPSS). The International Prostate Symptom Score is a 7-item questionnaire used to assess the severity of lower urinary tract symptoms. The total score ranges from 0 to 35, with higher scores indicating more severe symptoms. A greater decrease from baseline indicates greater improvement.
3 months and 6 months after surgery
Change From Baseline in Visual Analogue Scale (VAS) Score
Tijdsspanne: 3 months and 6 months after surgery
Change from baseline in Visual Analogue Scale (VAS) score. The Visual Analogue Scale is used to assess postoperative pain. The score ranges from 0 to 10, with 0 indicating no pain and 10 indicating the worst imaginable pain. Higher scores indicate more severe pain, and a greater decrease from baseline indicates greater improvement
3 months and 6 months after surgery

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline in Post-Void Residual Urine Volume (PVR)
Tijdsspanne: 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)
Tijdsspanne: 1 month, 3 months, and 6 months after surgery
Change from baseline in International Index of Erectile Function-5 (IIEF-5) score. The International Index of Erectile Function-5 is a 5-item questionnaire used to assess erectile function. The total score ranges from 5 to 25, with higher scores indicating better erectile function. A greater increase from baseline indicates greater improvement.
1 month, 3 months, and 6 months after surgery
Change From Baseline in Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD)
Tijdsspanne: 1 month, 3 months, and 6 months after surgery
Change from baseline in Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD) score. The Male Sexual Health Questionnaire-Ejaculatory Dysfunction is used to assess ejaculatory function. The ejaculatory function domain score ranges from 0 to 15, with higher scores indicating better ejaculatory function. A greater increase from baseline indicates greater improvement
1 month, 3 months, and 6 months after surgery
Exploratory 12-month follow-up outcomes
Tijdsspanne: 12 months after surgery
Exploratory long-term follow-up outcomes will be assessed at 12 months after surgery, including International Prostate Symptom Score (IPSS), quality of life (QoL) score, maximum urinary flow rate (Qmax), post-void residual urine volume (PVR), International Index of Erectile Function-5 (IIEF-5), Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD), reoperation or retreatment, and procedure-related adverse events. For score-based outcomes, the corresponding scale ranges and score directions are as follows: the International Prostate Symptom Score ranges from 0 to 35, with higher scores indicating more severe urinary symptoms; the quality of life score ranges from 0 to 6, with higher scores indicating worse quality of life related to urinary symptoms; the International Index of Erectile Function-5 score ranges from 5 to 25, with higher scores indicating better erectile function; and the Male Sexual Health Questionnaire-Ejaculatory Dysfunction ejaculatory function domain sc
12 months after surgery

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Chinese PLA General Hospital

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

1 december 2028

Studie voltooiing (Geschat)

1 december 2028

Studieregistratiedata

Eerst ingediend

29 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

29 april 2026

Eerst geplaatst (Werkelijk)

6 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

21 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

18 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ThuLEP-BNI-2026-161

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

No plan to share individual participant data at this time.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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