An interventional study of Transurethral Thulium Laser Enucleation of the Prostate (ThuLEP) and ThuLEP combined with transurethral bladder neck incision in Prostatic Hypertrophy, Benign, sponsored by Shanghai General Hospital, China. Recruiting at 1 site in China. Open to male participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by Shanghai General Hospital, China · Not applicable, Interventional, and Treatment
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:
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.
Benign prostatic hyperplasia (BPH) is a common urological disease in middle-aged and elderly men. With the acceleration of population aging in China, the incidence of BPH is continuously increasing. Domestic epidemiological data show that the prevalence of histological BPH is approximately 20% in men aged 50-60 years, 50% in those aged 61-70 years, 57.1% in those aged 71-80 years, and 83.3% in those aged 81-90 years. BPH leads to bladder outlet obstruction and changes in lower urinary tract symptoms, thereby significantly affecting patients' quality of life, and in advanced stages may result in bladder and renal dysfunction.
Transurethral resection of the prostate (TURP) has long been regarded as the "gold standard" for the surgical management of BPH by urologists. However, its application is limited by relatively high rates of postoperative complications, including bleeding, bladder neck contracture, urethral stricture, TUR syndrome, and a considerable reoperation rate. With the development and increasing application of laser technologies in urology, laser-based procedures have demonstrated growing advantages in the treatment of BPH.
Thulium (Tm) laser is a novel medical laser technology with a wavelength range of 1.75-2.22 μm. Thulium laser technology is characterized by simplicity of operation, minimal tissue injury, excellent hemostatic capability, and high precision. In recent years, it has developed rapidly and been widely adopted in urology. Transurethral thulium laser enucleation of the prostate is considered safe and efficient, with an easy learning curve, relatively short training period, and lower procedural cost, thus demonstrating broad clinical prospects.
The pathophysiology of bladder outlet obstruction in BPH can be divided into two major components: dynamic factors (increased smooth muscle tone of the prostate) and mechanical factors (urethral compression due to prostate enlargement) . Unlike large prostates (>80 mL), in most small-volume BPH cases, mechanical compression of the posterior urethra is not the predominant cause of obstruction. Some studies suggest that the main pathophysiological mechanisms in small prostates include bladder neck fibrosis, increased fibrous 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 population.
Based on these considerations, we propose a combined surgical approach consisting of transurethral laser enucleation of the prostate combined with bladder neck longitudinal incision. By surgically incising the bladder neck, this technique may simultaneously address both prostatic hyperplasia and bladder neck abnormalities. For patients with small prostates accompanied by bladder neck stenosis, fibrosis, or anatomical abnormalities (such as bladder neck elevation), this combined procedure may effectively correct both tissue obstruction and bladder neck dysfunction in a single stage.
Our center previously conducted a retrospective analysis on the efficacy and safety of thulium laser enucleation combined with bladder neck incision in the treatment of small-volume BPH. The study included 20 patients treated between June 2024 and December 2024. The patients were aged 63-77 years, with a mean age of 73 years. Prostate volume ranged from 19 to 29 mL, with a mean of 26 mL. All patients achieved satisfactory immediate urinary continence. With a follow-up period exceeding 12 months, no cases of bladder neck contracture were observed. The results suggest that thulium laser enucleation combined with bladder neck incision is an effective and safe treatment option for small-volume BPH.
For small-volume BPH, transurethral incision of the prostate (TUIP) is a guideline-recommended standard procedure. The core technique involves incision of the bladder neck and prostatic urethra, typically performed at the 5 o'clock and 7 o'clock positions, with partial resection of bladder neck tissue.
In the present study, the experimental group underwent only a single bladder neck incision at the 6 o'clock position following thulium laser enucleation. The depth of incision was consistent with that of TUIP. The incision was neither extended nor increased in number, resulting in minimal trauma 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 is supported by sound anatomical rationale and clinical safety considerations.
This study is a multicenter, randomized, single-blind clinical trial. The study population consists of male patients aged 50-85 years who meet the diagnostic criteria for benign prostatic hyperplasia (BPH) and require surgical intervention.A centralized randomization system will be used, and 120 participants will be allocated in a 1:1 ratio to the control group and the intervention group.
Group allocation and interventions:
Intervention group (n = 60): Transurethral thulium laser enucleation of the prostate (ThuLEP) combined with bladder neck incision.
Control group (n = 60): Transurethral thulium laser enucleation of the prostate (ThuLEP) alone.
Study duration: Patients will be followed up until 6 months postoperatively.
Primary objective:
To evaluate the improvement of postoperative lower urinary tract symptoms in patients with small-volume benign prostatic hyperplasia (BPH) treated with transurethral thulium laser enucleation of the prostate combined with bladder neck incision.
Primary outcome measure:
The maximum urinary flow rate (Qmax) at 6 months postoperatively in patients with small-volume BPH, which will also be used for sample size calculation.
Secondary objective 1:
To evaluate the safety and overall efficacy of transurethral thulium laser enucleation of the prostate combined with bladder neck incision in the treatment of small-volume BPH.
Outcome measures 1:
Perioperative vital signs; complete blood count; liver and renal function tests; serum electrolytes; and urinalysis. Intraoperative and early postoperative complications will be recorded, including severe bladder spasms, hematuria, and urinary tract injury or perforation. At 6 months postoperatively, IPSS score, post-void residual urine volume, and quality of life (QoL) will be assessed. Clinical outcomes will also include recurrence of voiding difficulty, weak urinary stream, and reduced urinary force, as well as the rates of urethral dilation, cystoscopy, and reoperation.
Secondary objective 2:
To assess the incidence of postoperative bladder neck contracture between the two groups.
Outcome measure 2:
The incidence rate of bladder neck contracture during the follow-up period in both groups.
827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
This study's planned enrollment of 120 is above the median of 92 across 626 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Shanghai General Hospital, China is the lead sponsor of 8 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
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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.
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.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
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.
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.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Patients in the control group will be treated with ThuLEP
Procedure: Transurethral Thulium Laser Enucleation of the Prostate (ThuLEP)
Patients in the intervention group will be treated with ThuLEP combined with transurethral bladder neck Incision
Procedure: ThuLEP combined with transurethral bladder neck incision
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.
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.
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.
Time frame: The sixth month after the operation
International prostate symptom score (IPSS)
The minimum value is 0, and maximum values 35. Higher scores mean a worse outcome.
Time frame: Perioperative period and 1st, 3rd, and 6th months after the operation
Quality of life score(QoL)
The minimum value is 0, and maximum values 6. Higher scores mean a worse outcome.
Time frame: Perioperative period and 1st, 3rd, and 6th months after the operation
Post-void residual urine volume (PVR)
Post-void residual urine volume is a key parameter for evaluating bladder emptying function, and in adult males it is generally considered to be less than 20 mL.
Time frame: Perioperative period and 1st, 3rd, and 6th months after the operation
maximum flow rate (Qmax)
As mentioned in the previous part
Time frame: The 1st and 3rd months after the operation
Incidence of bladder neck contracture
In patients with small-volume benign prostatic hyperplasia, one of the major postoperative complications is bladder neck contracture, which is difficult to manage and represents a key concern in clinical practice.
Time frame: The 1st, 3rd and 6th months after the operation
Complete blood count
Sample handling: discarded after use. Description: These tests are used solely for perioperative baseline assessment and safety evaluation. Blood samples were collected from veins and analyzed by the hospital's fully automatic blood analyzer. The results obtained mainly focused on the hemoglobin concentration (in g/L), which was used to assess the intraoperative bleeding of patients. All samples will be properly discarded after testing.
Time frame: Within 3 days before the operation and the first day of the operation
Urinalysis
Sample handling: discarded after use. Description: The samples are used solely for perioperative baseline assessment and evaluation of postoperative complications. After urine samples are collected, they are analyzed by the hospital urine analyzer, mainly focusing on the number of red blood cells and white blood cells (measured in cells per μL) to determine whether the patient has obvious hematuria or urinary tract infection .All specimens will be properly discarded after testing.
Time frame: Within 3 days before the operation and at 3 and 6 months postoperatively.
Plan to share: Yes
Supporting information: Study protocol, Informed consent form, Clinical study report
Start is estimated for Jul 2026; primary completion for Dec 2027, 17 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 17 months is below that.
Counting every sponsor, half of 203 studies reached it within 26 months; a quarter within 14 and three quarters within 48.
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Shanghai General Hospital, China