Multicenter Randomized Controlled Trial of ThuLEP Versus ThuLEP Combined With Bladder Neck Incision in Patients With Small-Volume Benign Prostatic Hyperplasia

NCT07688447 | Recruiting DMC

• 1 other identifier: 2026HS172
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

With the increasing degree of population aging, the number of patients undergoing surgical treatment for benign prostatic hyperplasia (BPH) is steadily rising. Among them, patients with small-volume prostates (≤30 mL) represent a distinct clinical subgroup. This population has several unique characteristics:

1. 1.Approximately 17.5% of patients show suboptimal postoperative outcomes.
2. 2.The incidence of postoperative bladder neck contracture (BNC) is relatively high, reaching up to 19.3% in some reports.

Conditions

Prostatic Hypertrophy, Benign

Keywords

Prostatic Hypertrophy

Outcome Measures

Primary Outcomes (1)

• Maximum flow rate (Qmax)

  Based on similar clinical studies, the primary efficacy endpoint was defined as the maximum urinary flow rate (Qmax) at 6 months postoperatively. In patients with small-volume prostates, the underlying pathophysiological mechanisms commonly include bladder neck fibrosis, increased fibrotic ring tension, and chronic prostatitis. In addition, bladder neck elevation and an increased prostatic urethral angle are also closely associated with lower urinary tract obstruction symptoms in this subgroup. In the experimental group, a combined surgical approach was applied. By performing a bladder neck incision, this technique may simultaneously address both prostatic tissue hyperplasia and bladder neck abnormalities in patients with small prostates who present with bladder neck stenosis, fibrosis, or anatomical alterations such as bladder neck elevation. Therefore, this combined approach may potentially lead to greater improvement in postoperative urinary flow parameters.

  The sixth month after the operation

Secondary Outcomes (7)

• International prostate symptom score (IPSS)

  Perioperative period and 1st, 3rd, and 6th months after the operation

• Quality of life score(QoL)

  Perioperative period and 1st, 3rd, and 6th months after the operation

• Post-void residual urine volume (PVR)

  Perioperative period and 1st, 3rd, and 6th months after the operation

• maximum flow rate (Qmax)

  The 1st and 3rd months after the operation

• Incidence of bladder neck contracture

  The 1st, 3rd and 6th months after the operation

Study Arms (2)

Control group

EXPERIMENTAL

Patients in the control group will be treated with ThuLEP

Procedure: Transurethral Thulium Laser Enucleation of the Prostate (ThuLEP)

Intervention group

EXPERIMENTAL

Patients in the intervention group will be treated with ThuLEP combined with transurethral bladder neck Incision

Procedure: ThuLEP combined with transurethral bladder neck incision

Interventions

Transurethral Thulium Laser Enucleation of the Prostate (ThuLEP) PROCEDURE

This technique is one of the mainstream surgical interventions for BPH, with its safety and efficacy well established in numerous studies, and is considered a mature and well-standardized procedure.

Control group

ThuLEP combined with transurethral bladder neck incision PROCEDURE

Bladder neck incision is also a well-established surgical approach for BPH, similar to transurethral incision of the prostate (TUIP). In the experimental group of this study, after transurethral thulium laser enucleation of the prostate, a single incision was made at the 6 o'clock position of the bladder neck. The depth of the incision was consistent with that of TUIP. The incision was not extended, and no additional incisions were created, resulting in minimal injury to the bladder neck. Theoretically, this approach does not increase the risk of complications such as bleeding, urinary incontinence, urethral stricture, or bladder neck contracture, and it is supported by both sound anatomical rationale and clinical safety considerations.

Intervention group

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patients aged 50-85 years who meet the diagnostic criteria for benign prostatic hyperplasia (BPH), with a prostate volume ≤30 mL and requiring surgical intervention.
• Preoperative International Prostate Symptom Score (IPSS) ≥8.
• Preoperative maximum urinary flow rate (Qmax) ≤15 mL/s.
• Bladder capacity ≥150 mL.
• Willing to participate in this clinical trial and has signed the informed consent form.
• Able to communicate well with investigators and comply with the study protocol requirements.

You may not qualify if:

• Patients with urethral stricture in whom passage of surgical instruments is not feasible.
• Total PSA \>10 ng/mL, or PSA between 4-10 ng/mL with a free-to-total PSA ratio \<0.16, and confirmed malignancy on biopsy.
• Coagulation disorders, including platelet count \<80 × 10⁹/L.
• Uncontrolled urinary tract infection.
• Neurogenic bladder.
• Presence of malignant tumors.
• Urodynamic diagnosis of bladder neck sclerosis, detrusor underactivity, detrusor-sphincter dyssynergia, or unstable bladder.
• Contraindications to surgery, such as severe cardiopulmonary disease.
• Cognitive impairment, including senile dementia, cerebral atrophy, acute cerebrovascular disease, sequelae of cerebrovascular disease, or other conditions affecting cognitive function.
• History of suprapubic cystostomy for benign prostatic hyperplasia.
• Acute localized or systemic bacterial infection that has not been effectively controlled.
• Presence of shock or other critical conditions that preclude cooperation with the procedure and outcome evaluation.
• Psychiatric or neurological disorders preventing cooperation with the study.
• Participation in another clinical trial within 1 month prior to enrollment.

Sponsors & Collaborators

• Weifang Traditional Chinese Medicine Hospital: collaborator
• The People's Hospital of Dehong Autonomous Prefecture: collaborator
• Shanghai General Hospital, China: lead
• Hunan Provincial People's Hospital: collaborator

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200086, China

RECRUITING

Related Publications (6)

• 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 BACKGROUND

• Ku JH, Ko DW, Cho JY, Oh SJ. Correlation between prostatic urethral angle and bladder outlet obstruction index in patients with lower urinary tract symptoms. Urology. 2010 Jun;75(6):1467-71. doi: 10.1016/j.urology.2009.08.049. Epub 2009 Dec 4.

  PMID: 19962734 BACKGROUND

• Li X, Pan JH, Liu QG, He P, Song SJ, Jiang T, Zhou ZS. Selective transurethral resection of the prostate combined with transurethral incision of the bladder neck for bladder outlet obstruction in patients with small volume benign prostate hyperplasia (BPH): a prospective randomized study. PLoS One. 2013 May 14;8(5):e63227. doi: 10.1371/journal.pone.0063227. Print 2013.

  PMID: 23691002 BACKGROUND

• Rieken M, Bachmann A. Laser treatment of benign prostate enlargement--which laser for which prostate? Nat Rev Urol. 2014 Mar;11(3):142-52. doi: 10.1038/nrurol.2014.23. Epub 2014 Mar 4.

  PMID: 24595121 BACKGROUND

• He W, Ding T, Niu Z, Hao C, Li C, Xu Z, Jing Y, Qin W. Reoperation after surgical treatment for benign prostatic hyperplasia: a systematic review. Front Endocrinol (Lausanne). 2023 Nov 9;14:1287212. doi: 10.3389/fendo.2023.1287212. eCollection 2023.

  PMID: 38027158 BACKGROUND

• Berry SJ, Coffey DS, Walsh PC, Ewing LL. The development of human benign prostatic hyperplasia with age. J Urol. 1984 Sep;132(3):474-9. doi: 10.1016/s0022-5347(17)49698-4.

  PMID: 6206240 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Yifeng Jing

CONTACT

+86-13918839913; jyf_123@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: July 7, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

CN (1)