An interventional study of Modified Prostatic Urethral Lift Using a Zero-Angle Firing and Needle-Guided Puncture Technique for Benign Prostatic Hyperplasia in BPH (Benign Prostatic Hyperplasia), sponsored by Qing Yuan. Completed at 1 site in China. Open to male participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Qing Yuan · Not applicable, Interventional, and Treatment
Among 53 studies in Prostatic Hyperplasia with a site in China — 22 open to participants now, 22 under way, 1 of them phase 3. Prostatic Hyperplasia · China.
Among the 53 studies in Prostatic Hyperplasia with a site in China, this one is the 39th largest by enrollment of the 40 interventional ones that give a count, is one of 3 that started in 2023, is one of 29 with no phase, and was the 51st registered.
828 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
Browse Prostatic Hyperplasia studies →22 of the 53 studies in Prostatic Hyperplasia with a site in China are open now. Recruiting first, the newest first:
Jiangsu Taizhou People's Hospital · Sites in China
Ages 15–90 · Men only
Shanghai General Hospital, China · Sites in China
Ages 50–85 · Men only
Peking University Third Hospital · Sites in China
Men only
Qing Yuan · Sites in China
Ages 40–80 · Men only
Ruijin Hospital · Sites in China
Ages 18–80 · Men only
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 102 Prostatic Hyperplasia studies recruiting now, 70 (69%) set no upper age limit and 4 (4%) stop at 75 or younger; 7 take children under 18; 7 take healthy volunteers.
This study: 50 Years to 80 Years · male · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
53 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 2 · Phase 3 5 · Phase 4 3
First in 2004; this study’s year is marked. 3 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 12 is below the median of 92 across 627 interventional studies indexed under Prostatic Hyperplasia.
Median enrollment 120 across the 40 interventional studies, 153 across the 13 observational. Of the 22 that completed or were terminated, 5 (23%) have results posted.
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12 of 53 have an industry lead sponsor. The 10 most frequent:
Qing Yuan is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Qing Yuan has 3 studies filed under Prostatic Hyperplasia — fewer than ten, so there is no comparison to draw.
9 of the studies in Prostatic Hyperplasia with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07146386Phase 3Shanghai Huilun Pharmaceutical Co., Ltd.A Phase III Clinical Study of H077 Sustained-Release Tablets Compared With Silodosin Capsules in the Treatment of Benign Prostatic Hyperplasia | 2027-01 |
| NCT07238959Shanghai Changzheng HospitalApplication of Quantum Detection-Driven Artificial Intelligence Algorithms for Single-Molecule cfDNA Characterization in the Early Diagnosis of Prostate Cancer | 2026-12 |
| NCT06817733Chinese PLA General HospitalClinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging | 2026-12-30 |
| NCT07357324The Fourth Affiliated Hospital of Zhejiang University School of MedicineA Clinical Observation Study of a Chinese Patent Medicine Combined With Tamsulosin in Improving Sleep and Nocturia Symptoms After Enucleation of the Prostate | 2026-12-31 |
| NCT06689514Yifeng JingStudy on the Effectiveness of Tranilast in the Treatment of Medium to Large Volume Benign Prostatic Hyperplasia | 2026-12-31 |
Add all 9 to your calendar (.ics) → With an account.
Among the 53 studies in Prostatic Hyperplasia with a site in China, from their registry updates:
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Abstract
Background:
Transurethral prostatic suspension and expansion, internationally referred to as prostatic urethral lift (PUL), is a minimally invasive treatment for lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH). However, implant deployment at the prostatic apex may be technically difficult because of limited lateral operating space and obstruction by the pubic arch. A modified technique involving zero-angle firing and needle-guided puncture was developed to facilitate implant placement in this region.
Objective:
This study aims to evaluate the feasibility, preliminary efficacy, and safety of the modified transurethral prostatic suspension and expansion procedure using zero-angle firing and needle-guided puncture in men with BPH-related lower urinary tract symptoms.
Methods:
This is a prospective, single-center, single-arm, open-label exploratory interventional study involving 12 male participants. The principal eligibility criteria include an age of 50-80 years, a prostate volume of 30-80 mL, an International Prostate Symptom Score (IPSS) greater than 12, a maximum urinary flow rate (Qmax) of 15 mL/s or less with a voided volume of at least 125 mL, and a post-void residual urine volume (PVR) of less than 350 mL. Patients with previous prostate surgery, confirmed or suspected prostate cancer, neurogenic bladder, urethral stricture, severe coagulation disorders, or anticoagulant therapy that cannot be safely discontinued or adjusted will be excluded.
All participants will undergo the modified transurethral prostatic suspension and expansion procedure. Implants will be deployed in the proximal and middle portions of the prostate using the conventional technique. At the prostatic apex, particularly when lateral rotation is restricted or pubic arch interference is anticipated, the delivery device will be maintained at the urethral midline in a neutral, zero-angle orientation. The needle will be fired in this position, followed by incremental manual compression to facilitate adequate tissue capture and needle-guided penetration of the prostatic capsule. The implant will then be tensioned and deployed.
Participants will be evaluated at baseline and followed at 14 days, 30 days, 90 days, and 12 months after surgery. The primary outcome is the change in IPSS from baseline to 90 days after surgery. Secondary outcomes include changes in quality-of-life score, Qmax, PVR, and Sexual Health Inventory for Men score; technical success; operative time; number of implants; estimated blood loss; catheterization duration; and length of hospital stay. Safety outcomes include gross hematuria, urinary urgency, dysuria, urinary retention, re-catheterization, urinary tract infection, urethral stricture, readmission, device-related adverse events, secondary intervention, and reoperation.
Continuous outcomes will be summarized using appropriate descriptive statistics and compared between baseline and follow-up using a paired-samples t-test or Wilcoxon signed-rank test, depending on the distribution of paired differences. Categorical variables will be reported as frequencies and percentages. All statistical tests will be two-sided, with a significance level of 0.05. Given the exploratory nature and small sample size, effect estimates and confidence intervals will be emphasized alongside P values.
Expected significance:
This study is expected to provide preliminary evidence regarding whether zero-angle firing and needle-guided puncture can facilitate implant deployment at the prostatic apex while improving urinary symptoms, urinary flow, and quality of life without adversely affecting erectile function. The findings may support the design of subsequent multicenter, controlled studies with larger sample sizes.
Keywords:
benign prostatic hyperplasia; lower urinary tract symptoms; transurethral prostatic suspension and expansion; prostatic urethral lift; zero-angle firing; needle-guided puncture; minimally invasive treatment
Registration information:
Study period: June 1, 2023 to December 31, 2023; ethics approval date: August 31, 2023; ethics approval number: S2023-493-01; principal investigator: Qing Yuan; planned sample size: 20 participants; registration status: retrospectively registered.
Abstract
Background:
Transurethral prostatic suspension and expansion, internationally referred to as prostatic urethral lift (PUL), is a minimally invasive treatment for lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH). However, implant deployment at the prostatic apex may be technically difficult because of limited lateral operating space and obstruction by the pubic arch. A modified technique involving zero-angle firing and needle-guided puncture was developed to facilitate implant placement in this region.
Objective:
This study aims to evaluate the feasibility, preliminary efficacy, and safety of the modified transurethral prostatic suspension and expansion procedure using zero-angle firing and needle-guided puncture in men with BPH-related lower urinary tract symptoms.
Methods:
This is a prospective, single-center, single-arm, open-label exploratory interventional study involving 12 male participants. The principal eligibility criteria include an age of 50-80 years, a prostate volume of 30-80 mL, an International Prostate Symptom Score (IPSS) greater than 12, a maximum urinary flow rate (Qmax) of 15 mL/s or less with a voided volume of at least 125 mL, and a post-void residual urine volume (PVR) of less than 350 mL. Patients with previous prostate surgery, confirmed or suspected prostate cancer, neurogenic bladder, urethral stricture, severe coagulation disorders, or anticoagulant therapy that cannot be safely discontinued or adjusted will be excluded.
All participants will undergo the modified transurethral prostatic suspension and expansion procedure. Implants will be deployed in the proximal and middle portions of the prostate using the conventional technique. At the prostatic apex, particularly when lateral rotation is restricted or pubic arch interference is anticipated, the delivery device will be maintained at the urethral midline in a neutral, zero-angle orientation. The needle will be fired in this position, followed by incremental manual compression to facilitate adequate tissue capture and needle-guided penetration of the prostatic capsule. The implant will then be tensioned and deployed.
Participants will be evaluated at baseline and followed at 14 days, 30 days, 90 days, and 12 months after surgery. The primary outcome is the change in IPSS from baseline to 90 days after surgery. Secondary outcomes include changes in quality-of-life score, Qmax, PVR, and Sexual Health Inventory for Men score; technical success; operative time; number of implants; estimated blood loss; catheterization duration; and length of hospital stay. Safety outcomes include gross hematuria, urinary urgency, dysuria, urinary retention, re-catheterization, urinary tract infection, urethral stricture, readmission, device-related adverse events, secondary intervention, and reoperation.
Continuous outcomes will be summarized using appropriate descriptive statistics and compared between baseline and follow-up using a paired-samples t-test or Wilcoxon signed-rank test, depending on the distribution of paired differences. Categorical variables will be reported as frequencies and percentages. All statistical tests will be two-sided, with a significance level of 0.05. Given the exploratory nature and small sample size, effect estimates and confidence intervals will be emphasized alongside P values.
Expected significance:
This study is expected to provide preliminary evidence regarding whether zero-angle firing and needle-guided puncture can facilitate implant deployment at the prostatic apex while improving urinary symptoms, urinary flow, and quality of life without adversely affecting erectile function. The findings may support the design of subsequent multicenter, controlled studies with larger sample sizes.
Keywords:
benign prostatic hyperplasia; lower urinary tract symptoms; transurethral prostatic suspension and expansion; prostatic urethral lift; zero-angle firing; needle-guided puncture; minimally invasive treatment
Registration information:
Study period: June 1, 2023 to December 31, 2023; ethics approval date: August 31, 2023; ethics approval number: S2023-493-01; principal investigator: Qing Yuan; planned sample size: 20 participants; registration status: retrospectively registered.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All enrolled patients receive unified surgical intervention, with standardized follow-up to observe clinical efficacy and safety indicators.
Procedure: Modified Prostatic Urethral Lift Using a Zero-Angle Firing and Needle-Guided Puncture Technique for Benign Prostatic Hyperplasia
Modified Prostatic Urethral Lift Using a Zero-Angle Firing and Needle-Guided Puncture Technique for Benign Prostatic Hyperplasia
International Prostate Symptom Score (IPSS) change from baseline
The IPSS score ranges from 0 to 35 points; higher scores indicate more severe lower urinary tract symptoms.
Time frame: Intraoperative period
Quality of life (QoL) score change from baseline
QoL score ranges from 0 to 6 points; higher scores indicate poorer quality of life
Time frame: intraoperative period
Maximum urinary flow rate (Qmax) change from baseline
Unit: ml/s; the higher the value, the better the urination function
Time frame: Intra-operative period
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2023 to primary completion in Dec 2023, 6 months.
Of 153 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 15 and three quarters within 48. This study's 6 months is below that.
Counting every sponsor, half of 205 studies reached it within 26 months; a quarter within 15 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Qing Yuan