Prostatic Hypertrophy, BenignNCT07688447
Multicenter Randomized Controlled Trial of ThuLEP Versus ThuLEP Combined With Bladder Neck Incision in Patients With Small-Volume Benign Prostatic Hyperplasia
A study testing Transurethral Thulium Laser Enucleation of the Prostate (ThuLEP) and ThuLEP combined with transurethral bladder neck incision in people with Prostatic Hypertrophy, Benign, run by Shanghai General Hospital, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years, men only
- Conditions the study is for
- Prostatic Hypertrophy, Benign
- What is being tested?
- Transurethral Thulium Laser Enucleation of the Prostate (ThuLEP) and ThuLEP combined with transurethral bladder neck incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
- Any other condition deemed inappropriate for inclusion by the investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200086
Wenqian Geng, +86 21 3612 6254, shiyilunli@sina.com
Junhao Xu, +86 13506500566, xjh837288022@163.com
About this study
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:
Read more
- Approximately 17.5% of patients show suboptimal postoperative outcomes.
- 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.
Read the detailed description
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.
- Conditions
- Prostatic Hypertrophy, Benign
- Being tested
- Transurethral Thulium Laser Enucleation of the Prostate (ThuLEP), ThuLEP combined with transurethral bladder neck incision
- Keywords
- Prostatic Hypertrophy
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transurethral Thulium Laser Enucleation of the Prostate (ThuLEP)Procedure or surgery
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.
ThuLEP combined with transurethral bladder neck incisionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | Patients in the control group will be treated with ThuLEP Receives: 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 Receives: Procedure: ThuLEP combined with transurethral bladder neck incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The sixth month after the operation
Secondary outcomes (7)
International prostate symptom score (IPSS)
The minimum value is 0, and maximum values 35. Higher scores mean a worse outcome.
Measured: 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.
Measured: 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.
Measured: Perioperative period and 1st, 3rd, and 6th months after the operation
maximum flow rate (Qmax)
As mentioned in the previous part
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 3 days before the operation and at 3 and 6 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Prostatic Hypertrophy, BenignStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai General Hospital, China
- Sponsor type
- University, hospital or other
- Collaborators
- Weifang Traditional Chinese Medicine Hospital, The People's Hospital of Dehong Autonomous Prefecture, Hunan Provincial People's Hospital
- Responsible party
- Principal investigator, Yifeng Jing, Shanghai General Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688447
- Sponsor's protocol ID
- 2026HS172
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 37202311Ku 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.
PubMed 19962734Li 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.
PubMed 23691002Rieken 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.
PubMed 24595121He 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.
PubMed 38027158Berry 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.
PubMed 6206240
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Controlled Trial of ThuLEP Versus ThuLEP Combined With Bladder Neck Incision in Patients With Small-Volume Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT07688447
- Acronym / sponsor ID
- 2026HS172
- Conditions
- Prostatic Hypertrophy, Benign
- Keywords
- Prostatic Hypertrophy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, ChinaUniversity, hospital or other
- Collaborators
- Weifang Traditional Chinese Medicine Hospital, The People's Hospital of Dehong Autonomous Prefecture, Hunan Provincial People's Hospital
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Approximately 17.5% of patients show suboptimal postoperative outcomes.
- 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Procedure: Transurethral Thulium Laser Enucleation of the Prostate (ThuLEP)Patients in the control group will be treated with ThuLEP |
| Intervention group | Experimental | Procedure: ThuLEP combined with transurethral bladder neck incisionPatients in the intervention group will be treated with ThuLEP combined with transurethral bladder neck Incision |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Control group |
| ThuLEP combined with transurethral bladder neck incisionBladder 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. | Procedure or surgery | Intervention group |
Primary outcome
Maximum flow rate (Qmax)
Time frame: The sixth month after the operation
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.
7 secondary outcomes
International prostate symptom score (IPSS)
Time frame: Perioperative period and 1st, 3rd, and 6th months after the operation
Quality of life score(QoL)
Time frame: Perioperative period and 1st, 3rd, and 6th months after the operation
Post-void residual urine volume (PVR)
Time frame: Perioperative period and 1st, 3rd, and 6th months after the operation
maximum flow rate (Qmax)
Time frame: The 1st and 3rd months after the operation
Incidence of bladder neck contracture
Time frame: The 1st, 3rd and 6th months after the operation
Complete blood count
Time frame: Within 3 days before the operation and the first day of the operation
Urinalysis
Time frame: Within 3 days before the operation and at 3 and 6 months postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Background: PubMed 37202311Gravas 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.
- Background: PubMed 19962734Ku 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.
- Background: PubMed 23691002Li 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.
- Background: PubMed 24595121Rieken 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.
- Background: PubMed 38027158He 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.
- Background: PubMed 6206240Berry 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transurethral Thulium Laser Enucleation of the Prostate (ThuLEP) and ThuLEP combined with transurethral bladder neck incision in people with Prostatic Hypertrophy, Benign, run by Shanghai General Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yifeng Jing (+86-13918839913, jyf_123@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum flow rate (Qmax) (time frame: The sixth month after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07688447, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.