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

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

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexMale

Age40-80

SponsorChinese PLA General Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Thulium Laser Enucleation of the Prostate Combined With Bladder Neck Incision
Procedure/Surgery
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.
Thulium Laser Enucleation of the Prostate
Procedure/Surgery
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.
Transurethral Resection of the Prostate
Procedure/Surgery
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.
Transurethral Incision of the Prostate
Procedure/Surgery
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.

Treatment groups

932 Participants

are divided into 4 treatment groups

Group A: ThuLEP Combined With Bladder Neck IncisionExperimental treatment 1 intervention

Group B: ThuLEP AloneActive comparator 1 intervention

Group C: Transurethral Resection of the ProstateActive comparator 1 intervention

Group D: Transurethral Incision of the Prostate (TUIP)Active comparator 1 intervention

Trial outcomes

Primary outcomes

Incidence of Bladder Neck Contracture

Bladder neck contracture will be assessed based on postoperative symptoms, changes in urinary flow, cystoscopic findings, and investigator judgment.

Time frame

6 months after surgery (180 ± 7 days)

Secondary outcomes

Incidence of Postoperative Retrograde Ejaculation

Incidence of postoperative retrograde ejaculation during follow-up.

Time frame

Up to 6 months after surgery

Incidence of Device-Related New-Onset Severe Urinary Retention

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.

Time frame

Up to 6 months after surgery

Incidence of Device-Related New-Onset Stress Urinary Incontinence

Incidence of device-related new-onset stress urinary incontinence during follow-up.

Time frame

Up to 6 months after surgery

Incidence of Device-Related Bleeding Events Requiring Blood Transfusion

Incidence of device-related bleeding events requiring blood transfusion during follow-up.

Time frame

Up to 6 months after surgery

Other outcomes

Change From Baseline in Post-Void Residual Urine Volume (PVR)

Change from baseline in post-void residual urine volume (PVR).

Time frame

1 month, 3 months, and 6 months after surgery

Change From Baseline in International Index of Erectile Function-5 (IIEF-5)

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.

Time frame

1 month, 3 months, and 6 months after surgery

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

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

Time frame

1 month, 3 months, and 6 months after surgery

Exploratory 12-month follow-up outcomes

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

Time frame

12 months after surgery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese PLA General Hospital

Lead sponsor

Source ClinicalTrials.gov

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