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

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

In addition, the pathophysiological mechanisms of small-volume BPH are different from those of larger prostates. These include increased fibrotic tension of the bladder neck and bladder neck elevation.

At present, there is no clearly established surgical approach specifically designed to further improve postoperative outcomes or effectively prevent bladder neck contracture in patients with small-volume BPH.

This study primarily compares the safety and efficacy of transurethral thulium laser enucleation of the prostate (ThuLEP) versus ThuLEP combined with bladder neck incision in the treatment of small-volume benign prostatic hyperplasia (BPH), with the aim of further optimizing surgical management strategies for small prostates and reducing the incidence of postoperative complications.

Conditions

• Prostatic Hypertrophy, Benign

Interventions

PROCEDURE

Transurethral Thulium Laser Enucleation of the Prostate (ThuLEP)

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.

PROCEDURE

ThuLEP combined with transurethral bladder neck incision

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.

Sponsors & Collaborators

• Weifang Traditional Chinese Medicine Hospital

  collaborator OTHER

• The People's Hospital of Dehong Autonomous Prefecture

  collaborator OTHER

• Hunan Provincial People's Hospital

  collaborator OTHER

• Shanghai General Hospital, China

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

85 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2027-12-31

Completion

2027-12-31

Countries

• China

Study Locations