An interventional study of Thulium Laser Enucleation of the Prostate Combined With Bladder Neck Incision and Thulium Laser Enucleation of the Prostate in Benign Prostatic Hyperplasia, Bladder Outlet Obstruction and Lower Urinary Tract Symptoms (LUTS), sponsored by Chinese PLA General Hospital. Not yet recruiting at 1 site in China. Open to male participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Chinese PLA General Hospital · Not applicable, Interventional, and Treatment
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.
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.
827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
This study's planned enrollment of 932 is above the median of 92 across 626 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Chinese PLA General Hospital is the lead sponsor of 570 studies on the registry; 207 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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 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 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 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.
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
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
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.
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)
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
Incidence of Device-Related Urethral or Prostatic Capsule Rupture Requiring Surgical Intervention
Incidence of device-related urethral or prostatic capsule rupture requiring surgical intervention during follow-up.
Time frame: Up to 6 months after surgery
Change From Baseline in International Prostate Symptom Score (IPSS)
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.
Time frame: 3 months and 6 months after surgery
IPSS Response Rate
Proportion of participants achieving improvement in IPSS from baseline of at least 30%, 40%, or 50%.
Time frame: 3 months and 6 months after surgery
Change From Baseline in Maximum Urinary Flow Rate (Qmax)
Change from baseline in maximum urinary flow rate (Qmax).
Time frame: 3 months and 6 months after surgery
Change From Baseline in Visual Analogue Scale (VAS) Score
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
Time frame: 3 months and 6 months after surgery
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
Plan to share: No — No plan to share individual participant data at this time.
Start is estimated for Jul 2026; primary completion for Dec 2028, 29 months later.
Of 152 non-industry interventional studies with no phase under Prostatic Hyperplasia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 29 months is above that.
Counting every sponsor, half of 203 studies reached it within 26 months; a quarter within 14 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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