Benign Prostatic HyperplasiaThuLEP-BNINCT07569874
Thulium Laser Enucleation With Bladder Neck Incision for Small-Volume Benign Prostatic Hyperplasia
A study testing Thulium Laser Enucleation of the Prostate Combined With Bladder Neck Incision, Thulium Laser Enucleation of the Prostate and Transurethral Resection of the Prostate in people with Benign Prostatic Hyperplasia and Bladder Outlet Obstruction, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Bladder Outlet Obstruction, Lower Urinary Tract Symptoms (LUTS)
- What is being tested?
- Thulium Laser Enucleation of the Prostate Combined With Bladder Neck Incision, Thulium Laser Enucleation of the Prostate and Transurethral Resection of the Prostate
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 932 participants
- Where
- 1 siteChina
- Study dates
- Jul 2026to Dec 2028
- 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 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Ability, as assessed by the investigator, to understand the study requirements and complete the scheduled treatment, follow-up visits, and study-related assessments.
Who cannot join
- 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.
- Known coagulation disorder or abnormal coagulation function.
- Neurogenic bladder or detrusor underactivity that may affect bladder or urethral sphincter function.
Show all 12Show fewer
- Benign prostatic hyperplasia (BPH) complicated by acute urinary tract infection, acute prostatitis, or bacterial prostatitis.
- History of prostate surgery, urethral stricture, or neurogenic bladder.
- History of prostate cancer or pelvic radiotherapy.
- Severe cardiovascular disease, pulmonary disease, or other systemic disease that, in the investigator's judgment, would make the patient unable to tolerate surgery.
- Participation in another clinical trial related to benign prostatic hyperplasia (BPH) within 3 months before enrolment.
- Any other condition that, in the investigator's opinion, makes the patient unsuitable for participation in this study.
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
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100039
Qing Yuan, MD, PhD, +8618910980422, qyuanmd@outlook.com
About this study
Official title: Thulium Laser Enucleation of the Prostate Combined With Bladder Neck Incision for Small-Volume Benign Prostatic Hyperplasia: A Multicentre, Randomized, Single-Blind, Four-Arm Controlled 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.
Read the detailed description
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.
- Conditions
- Benign Prostatic Hyperplasia, Bladder Outlet Obstruction, Lower Urinary Tract Symptoms (LUTS)
- Being tested
- Thulium Laser Enucleation of the Prostate Combined With Bladder Neck Incision, Thulium Laser Enucleation of the Prostate, Transurethral Resection of the Prostate, Transurethral Incision of the Prostate
- Keywords
- Small-Volume Benign Prostatic Hyperplasia, Thulium Laser Enucleation of the Prostate, Bladder Neck Incision, Bladder Neck Contracture, Lower Urinary Tract Symptoms
- Medical subject headings
- Prostatic Hyperplasia, Urinary Bladder Neck Obstruction, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thulium Laser Enucleation of the Prostate Combined With Bladder Neck IncisionProcedure or 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 ProstateProcedure or surgery
Also called ThuLEP
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 ProstateProcedure or surgery
Also called TURP
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 ProstateProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| ThuLEP Combined With Bladder Neck Incision | Experimental | 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. Receives: Procedure: Thulium Laser Enucleation of the Prostate Combined With Bladder Neck Incision |
| ThuLEP Alone | Active comparator | 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. Receives: Procedure: Thulium Laser Enucleation of the Prostate |
| Transurethral Resection of the Prostate | Active comparator | 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. Receives: Procedure: Transurethral Resection of the Prostate |
| Transurethral Incision of the Prostate (TUIP) | Active comparator | 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. Receives: Procedure: Transurethral Incision of the Prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Bladder Neck Contracture
Bladder neck contracture will be assessed based on postoperative symptoms, changes in urinary flow, cystoscopic findings, and investigator judgment.
Measured: 6 months after surgery (180 ± 7 days)
Secondary outcomes (9)
Incidence of Postoperative Retrograde Ejaculation
Incidence of postoperative retrograde ejaculation during follow-up.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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%.
Measured: 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).
Measured: 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
Measured: 3 months and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study startJul 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies 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
- Model description
- Participants will be randomly assigned in a 1:1:1:1 ratio to one of four parallel 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, or transurethral incision of the prostate.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 932 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing Yuan, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569874
- Sponsor's protocol ID
- ThuLEP-BNI-2026-161
- Acronym
- ThuLEP-BNI
- Status last verified
- Jul 2026
- First submitted
- 29 Apr 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data at this time.
Publications
Gomes CM, Nunes RV, Araujo RM, Sacomani CR, Trigo-Rocha FE, Bruschini H, Srougi M. Urodynamic evaluation of patients with lower urinary tract symptoms and small prostate volume. Urol Int. 2008;81(2):129-34. doi: 10.1159/000144049. Epub 2008 Aug 29.
PubMed 18758208Gravas 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 37202311Dias US Jr, de Moura MRL, Viana PCC, de Assis AM, Marcelino ASZ, Moreira AM, Leite CC, Cerri GG, Carnevale FC, Horvat N. Prostatic Artery Embolization: Indications, Preparation, Techniques, Imaging Evaluation, Reporting, and Complications. Radiographics. 2021 Sep-Oct;41(5):1509-1530. doi: 10.1148/rg.2021200144. Epub 2021 Aug 20.
PubMed 34415807Lee SWH, Chan EMC, Lai YK. The global burden of lower urinary tract symptoms suggestive of benign prostatic hyperplasia: A systematic review and meta-analysis. Sci Rep. 2017 Aug 11;7(1):7984. doi: 10.1038/s41598-017-06628-8.
PubMed 28801563Lerner LB, McVary KT, Barry MJ, Bixler BR, Dahm P, Das AK, Gandhi MC, Kaplan SA, Kohler TS, Martin L, Parsons JK, Roehrborn CG, Stoffel JT, Welliver C, Wilt TJ. Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA GUIDELINE PART I-Initial Work-up and Medical Management. J Urol. 2021 Oct;206(4):806-817. doi: 10.1097/JU.0000000000002183. Epub 2021 Aug 13.
PubMed 34384237
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thulium Laser Enucleation of the Prostate Combined With Bladder Neck Incision for Small-Volume Benign Prostatic Hyperplasia: A Multicentre, Randomized, Single-Blind, Four-Arm Controlled Trial
- ClinicalTrials.gov ID
- NCT07569874
- Acronym / sponsor ID
- ThuLEP-BNI / ThuLEP-BNI-2026-161
- Conditions
- Benign Prostatic Hyperplasia, Bladder Outlet Obstruction, Lower Urinary Tract Symptoms (LUTS)
- Keywords
- Small-Volume Benign Prostatic Hyperplasia, Thulium Laser Enucleation of the Prostate, Bladder Neck Incision, Bladder Neck Contracture, Lower Urinary Tract Symptoms
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 932 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 May 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants will be randomly assigned in a 1:1:1:1 ratio to one of four parallel 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, or transurethral incision of the prostate.
| Arm | Type | Receives |
|---|---|---|
| ThuLEP Combined With Bladder Neck Incision | Experimental | Procedure: Thulium Laser Enucleation of the Prostate Combined With Bladder Neck IncisionParticipants 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. |
| ThuLEP Alone | Active comparator | Procedure: Thulium Laser Enucleation of the ProstateParticipants 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. |
| Transurethral Resection of the Prostate | Active comparator | Procedure: Transurethral Resection of the ProstateParticipants 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. |
| Transurethral Incision of the Prostate (TUIP) | Active comparator | Procedure: Transurethral Incision of the ProstateParticipants 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Ability, as assessed by the investigator, to understand the study requirements and complete the scheduled treatment, follow-up visits, and study-related assessments.
Key exclusion criteria (12 listed)
- 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.
- Known coagulation disorder or abnormal coagulation function.
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 |
|---|---|---|
| Thulium Laser Enucleation of the Prostate Combined With Bladder Neck IncisionParticipants 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. | Procedure or surgery | ThuLEP Combined With Bladder Neck Incision |
| Thulium Laser Enucleation of the ProstateAlso: ThuLEPParticipants 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. | Procedure or surgery | ThuLEP Alone |
| Transurethral Resection of the ProstateAlso: TURPParticipants 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 or surgery | Transurethral Resection of the Prostate |
| Transurethral Incision of the ProstateParticipants 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. | Procedure or surgery | Transurethral Incision of the Prostate (TUIP) |
Primary outcome
Incidence of Bladder Neck Contracture
Time frame: 6 months after surgery (180 ± 7 days)
Bladder neck contracture will be assessed based on postoperative symptoms, changes in urinary flow, cystoscopic findings, and investigator judgment.
9 secondary outcomes
Incidence of Postoperative Retrograde Ejaculation
Time frame: Up to 6 months after surgery
Incidence of Device-Related New-Onset Severe Urinary Retention
Time frame: Up to 6 months after surgery
Incidence of Device-Related New-Onset Stress Urinary Incontinence
Time frame: Up to 6 months after surgery
Incidence of Device-Related Bleeding Events Requiring Blood Transfusion
Time frame: Up to 6 months after surgery
Incidence of Device-Related Urethral or Prostatic Capsule Rupture Requiring Surgical Intervention
Time frame: Up to 6 months after surgery
Change From Baseline in International Prostate Symptom Score (IPSS)
Time frame: 3 months and 6 months after surgery
IPSS Response Rate
Time frame: 3 months and 6 months after surgery
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
Time frame: 3 months and 6 months after surgery
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 21 Jul 2026.
- Results publication: PubMed 18758208Gomes CM, Nunes RV, Araujo RM, Sacomani CR, Trigo-Rocha FE, Bruschini H, Srougi M. Urodynamic evaluation of patients with lower urinary tract symptoms and small prostate volume. Urol Int. 2008;81(2):129-34. doi: 10.1159/000144049. Epub 2008 Aug 29.
- Results publication: 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.
- Results publication: PubMed 34415807Dias US Jr, de Moura MRL, Viana PCC, de Assis AM, Marcelino ASZ, Moreira AM, Leite CC, Cerri GG, Carnevale FC, Horvat N. Prostatic Artery Embolization: Indications, Preparation, Techniques, Imaging Evaluation, Reporting, and Complications. Radiographics. 2021 Sep-Oct;41(5):1509-1530. doi: 10.1148/rg.2021200144. Epub 2021 Aug 20.
- Results publication: PubMed 28801563Lee SWH, Chan EMC, Lai YK. The global burden of lower urinary tract symptoms suggestive of benign prostatic hyperplasia: A systematic review and meta-analysis. Sci Rep. 2017 Aug 11;7(1):7984. doi: 10.1038/s41598-017-06628-8.
- Results publication: PubMed 34384237Lerner LB, McVary KT, Barry MJ, Bixler BR, Dahm P, Das AK, Gandhi MC, Kaplan SA, Kohler TS, Martin L, Parsons JK, Roehrborn CG, Stoffel JT, Welliver C, Wilt TJ. Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA GUIDELINE PART I-Initial Work-up and Medical Management. J Urol. 2021 Oct;206(4):806-817. doi: 10.1097/JU.0000000000002183. Epub 2021 Aug 13.
- Individual participant dataSharing planned: No. No plan to share individual participant data at this time.
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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 Thulium Laser Enucleation of the Prostate Combined With Bladder Neck Incision, Thulium Laser Enucleation of the Prostate and Transurethral Resection of the Prostate in people with Benign Prostatic Hyperplasia and Bladder Outlet Obstruction, run by Chinese PLA General Hospital 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 5 inclusion and 12 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: opening soon, as of the sponsor's last update on 21 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 Qing Yuan, MD, PhD (+8618910980422, qyuanmd@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Bladder Neck Contracture (time frame: 6 months after surgery (180 ± 7 days)). 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 NCT07569874, which also lists 5 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 21 Jul 2026.