Thulium Laser Enucleation With Bladder Neck Incision for Small-Volume Benign Prostatic Hyperplasia

NCT07569874 | Not Yet Recruiting DMC

• 1 other identifier: ThuLEP-BNI-2026-161
• Study Type: interventional
• Target: 932
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Benign Prostatic Hyperplasia; Bladder Outlet Obstruction; Lower Urinary Tract Symptoms (LUTS)

Keywords

Small-Volume Benign Prostatic Hyperplasia; Thulium Laser Enucleation of the Prostate; Bladder Neck Incision; Bladder Neck Contracture; Lower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (1)

• Incidence of Bladder Neck Contracture

  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)

Secondary Outcomes (9)

• Incidence of Postoperative Retrograde Ejaculation

  Up to 6 months after surgery

• Incidence of Device-Related New-Onset Severe Urinary Retention

  Up to 6 months after surgery

• Incidence of Device-Related New-Onset Stress Urinary Incontinence

  Up to 6 months after surgery

• Incidence of Device-Related Bleeding Events Requiring Blood Transfusion

  Up to 6 months after surgery

• Incidence of Device-Related Urethral or Prostatic Capsule Rupture Requiring Surgical Intervention

  Up to 6 months after surgery

Other Outcomes (4)

• 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)

  1 month, 3 months, and 6 months after surgery

• Change From Baseline in Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD)

  1 month, 3 months, and 6 months after surgery

Study Arms (4)

ThuLEP Combined With Bladder Neck Incision

EXPERIMENTAL

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

ThuLEP Alone

ACTIVE COMPARATOR

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

Transurethral Resection of the Prostate

ACTIVE COMPARATOR

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

Transurethral Incision of the Prostate (TUIP)

ACTIVE COMPARATOR

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

Interventions

Transurethral Incision of the Prostate PROCEDURE

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.

Transurethral Incision of the Prostate (TUIP)

Transurethral Resection of the Prostate PROCEDURE

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.

Also known as: TURP

Transurethral Resection of the Prostate

Thulium Laser Enucleation of the Prostate Combined With Bladder Neck Incision PROCEDURE

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.

ThuLEP Combined With Bladder Neck Incision

Thulium Laser Enucleation of the Prostate PROCEDURE

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.

Also known as: ThuLEP

ThuLEP Alone

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100039, China

Location

Related Publications (5)

• 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.

  PMID: 18758208 RESULT

• 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.

  PMID: 37202311 RESULT

• 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.

  PMID: 34415807 RESULT

• 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.

  PMID: 28801563 RESULT

• 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.

  PMID: 34384237 RESULT

MeSH Terms

Conditions

Prostatic Hyperplasia; Urinary Bladder Neck Obstruction; Lower Urinary Tract Symptoms

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Qing Yuan, MD, PhD

CONTACT

+8618910980422; qyuanmd@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the surgical interventions, operating surgeons and the surgical team cannot be blinded. Participants will not be actively informed of their treatment allocation whenever feasible. Postoperative outcome assessors and statisticians will remain blinded to treatment allocation whenever possible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief Physician

Model Details: Participants will be randomly assigned in a 1:1:1:1 ratio to one of four parallel 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, or transurethral incision of the prostate.

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 6, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)