BPH (Benign Prostatic Hyperplasia)UMPD-BPHNCT07583706
A Single-center, Single-arm Study to Evaluate the Safety and Efficacy of Ultra-minimally Invasive Prostate Dilation in Treating Patients With Significant Obstructive Symptoms Caused by Benign Prostatic Hyperplasia
A study testing Prostate Dilation Catheter in people with BPH (Benign Prostatic Hyperplasia), run by Qing Yuan at 1 site in China.
Trial summary
This single-center, single-arm, prospective clinical study aims to preliminarily evaluate the safety and effectiveness of ultra-minimally invasive prostatic dilation using a prostate dilation catheter under real-time transrectal ultrasound (TRUS) guidance in male patients with significant bladder outlet obstruction… Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- BPH (Benign Prostatic Hyperplasia)
- What is being tested?
- Prostate Dilation Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 1 Sep 2026
- 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 subjects aged 40 to 80 years with symptomatic benign prostatic hyperplasia (BPH) and obvious bladder outlet obstruction.
- Subjects with normal sexual life and a sexual partner, and with intact sexual function.
- International Prostate Symptom Score (IPSS) ≥ 13.
- Maximum urinary flow rate (Qmax) between 5 and 10 mL/s, with a minimum voided volume ≥ 150 mL.
- Prostate volume measured by transrectal ultrasound (TRUS) < 30 mL. Prostate volume is calculated as length × width × height × 0.52.
- Subjects who, in the investigator's opinion, are able to complete the study protocol.
Who cannot join
- Subjects who are unable or unwilling to sign the informed consent form (ICF) and/or comply with all follow-up requirements.
- Subjects who are unwilling to abstain from sexual activity or use protective sexual behavior within 90 days after treatment.
- Prostate-specific antigen (PSA) ≥ 10 ng/mL, unless prostate cancer has been excluded by biopsy.
- Confirmed or suspected prostate or bladder malignancy.
- Use of antiplatelet drugs, such as clopidogrel or aspirin, within 10 days before surgery, or planned use within 5 days after surgery.
- Use of medications within 3 months before surgery that, in the investigator's opinion, may affect sexual function.
- Presence of neurogenic bladder or detrusor underactivity affecting bladder/sphincter function.
- Patients with BPH complicated by acute urinary tract infection, acute prostatitis, or bacterial prostatitis.
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
Qing Yuan
Beijing, 100000
Qing Yuan, 19917508192, rentangl@163.com
Rentang Li, 19917508192, rentangl@163.com
About this study
This single-center, single-arm, prospective clinical study aims to preliminarily evaluate the safety and effectiveness of ultra-minimally invasive prostatic dilation using a prostate dilation catheter under real-time transrectal ultrasound (TRUS) guidance in male patients with significant bladder outlet obstruction secondary to benign prostatic hyperplasia (BPH).
A total of 5 eligible male subjects aged 40 to 80 years with symptomatic BPH, International Prostate Symptom Score (IPSS) ≥13, maximum urinary flow rate (Qmax) of 5-10 mL/s, prostate volume <30 mL measured by TRUS, and evident bladder outlet obstruction will be enrolled. All subjects will undergo prostatic balloon dilation with the study device under real-time TRUS guidance. Follow-up assessments will be conducted at 1, 3, and 6 months after treatment.
Read more
The primary effectiveness endpoint is the change in IPSS from baseline at 1, 3, and 6 months. The primary safety endpoints include bladder neck contracture, retrograde ejaculation, device-related severe urinary retention persisting for more than 14 days after healing, new-onset stress urinary incontinence, device-related bleeding requiring transfusion, and device-related urethral or prostatic capsular rupture requiring surgical intervention.
Secondary endpoints include responder rates based on different thresholds of IPSS improvement (≥30%, ≥40%, and ≥50%), changes in Qmax, and changes in visual analogue scale (VAS) scores. Exploratory endpoints include changes in postvoid residual urine volume (PVR) and sexual function assessed by the International Index of Erectile Function (IIEF-5) and the Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD).
This exploratory study is intended to provide preliminary clinical evidence supporting the safety and potential clinical benefit of TRUS-guided ultra-minimally invasive prostatic dilation for BPH-related obstruction and to inform future larger-scale clinical studies.
Read the detailed description
This is a single-center, single-arm, prospective exploratory clinical study designed to preliminarily evaluate the safety and effectiveness of ultra-minimally invasive prostatic dilation using a dedicated prostate dilation catheter under real-time transrectal ultrasound (TRUS) guidance in patients with benign prostatic hyperplasia (BPH) associated with significant bladder outlet obstruction.
A total of 5 eligible male participants will be enrolled. Eligible subjects are 40 to 80 years of age, have moderate to severe lower urinary tract symptoms, an International Prostate Symptom Score (IPSS) of at least 13, a maximum urinary flow rate (Qmax) between 5 and 10 mL/s, and a prostate volume less than 30 mL as measured by TRUS. All participants must have clinically confirmed BPH with significant bladder outlet obstruction and preserved sexual function. Key exclusion criteria include suspected or confirmed malignancy, severe urinary tract infection, bleeding tendency, neurogenic bladder, and other conditions considered unsuitable for the procedure.
After providing written informed consent, each participant will undergo ultra-minimally invasive prostatic dilation with the study device under real-time TRUS guidance. The procedure is intended to be performed in a minimally invasive setting without the need for general anesthesia. Follow-up evaluations will be conducted at 1, 3, and 6 months after treatment.
Efficacy assessments will focus on changes from baseline in IPSS at 1, 3, and 6 months after the procedure. Safety assessments will include the occurrence of adverse events such as bladder neck contracture, retrograde ejaculation, device-related prolonged urinary retention lasting more than 14 days after healing, stress urinary incontinence, bleeding requiring transfusion, and urethral or prostatic capsular rupture requiring surgical intervention. Secondary outcomes include responder rates based on different thresholds of IPSS improvement, changes in Qmax and visual analogue scale (VAS) scores, and exploratory changes in postvoid residual urine volume (PVR) and sexual function parameters, including the International Index of Erectile Function-5 (IIEF-5) and the Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD).
This study is intended to generate preliminary clinical evidence regarding the safety and potential therapeutic benefit of TRUS-guided ultra-minimally invasive prostatic dilation for the treatment of BPH-related bladder outlet obstruction, and to support the design of future larger-scale clinical investigations.
- Conditions
- BPH (Benign Prostatic Hyperplasia)
- Being tested
- Prostate Dilation Catheter
- Keywords
- Benign Prostatic Hyperplasia, LUTS
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate Dilation CatheterDevice
Also called TRUS-guided ultra-minimally invasive prostatic dilation
The intervention consists of ultra-minimally invasive dilation of the prostatic urethra using a dedicated prostate dilation catheter under real-time transrectal ultrasound guidance. The treatment is designed to relieve bladder outlet obstruction caused by benign prostatic hyperplasia while preserving urinary and sexual function.
| Study group | Role | What they receive |
|---|---|---|
| TRUS-Guided Prostatic Dilation Group | Experimental | Participants in this arm will receive ultra-minimally invasive prostatic dilation using a dedicated prostate dilation catheter under real-time transrectal ultrasound guidance for the treatment of benign prostatic hyperplasia-associated bladder outlet obstruction. Receives: Device: Prostate Dilation Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in International Prostate Symptom Score from baseline to 3 months after treatment
The International Prostate Symptom Score, or IPSS, will be used to evaluate lower urinary tract symptoms associated with benign prostatic hyperplasia. The score ranges from 0 to 35, with higher scores indicating more severe symptoms. The change in IPSS from baseline to 3 months after treatment will be assessed.
Measured: Baseline and 3 months after treatment
Secondary outcomes (2)
Change in maximum urinary flow rate from baseline to 3 months after treatment
Maximum urinary flow rate, or Qmax, will be measured by uroflowmetry. The change in Qmax from baseline to 3 months after treatment will be assessed. A higher Qmax indicates improved urinary flow.
Measured: Baseline and 3 months after treatment
Incidence of treatment-related adverse events
The incidence, severity, and relationship to the study procedure or device of adverse events will be recorded throughout the study. Adverse events may include hematuria, urinary tract infection, urinary retention, pain, dysuria, urethral injury, or other procedure-related complications.
Measured: From treatment to 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start1 Jan 2026
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPH (Benign Prostatic Hyperplasia)Studies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-center, single-arm, prospective exploratory study. All enrolled participants will receive TRUS-guided ultra-minimally invasive prostatic dilation using the investigational prostate dilation catheter. No control group or randomization is included.
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qing Yuan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qing Yuan, Chinese PLA General Hospital
- Investigators
- Qing Yuan, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583706
- Sponsor's protocol ID
- S2025-982-01
- Acronym
- UMPD-BPH
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because this is a small, single-center exploratory study and the data contain sensitive clinical information, including urological symptoms and sexual function assessments. To protect participant privacy and confidentiality, individual-level data will not be made available. Aggregate study results may be shared after completion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Single-arm Study to Evaluate the Safety and Efficacy of Ultra-minimally Invasive Prostate Dilation in Treating Patients With Significant Obstructive Symptoms Caused by Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT07583706
- Acronym / sponsor ID
- UMPD-BPH / S2025-982-01
- Conditions
- BPH (Benign Prostatic Hyperplasia)
- Keywords
- Benign Prostatic Hyperplasia, LUTS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Qing YuanUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 13 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 single-center, single-arm, prospective clinical study aims to preliminarily evaluate the safety and effectiveness of ultra-minimally invasive prostatic dilation using a prostate dilation catheter under real-time transrectal ultrasound (TRUS) guidance in male patients with significant bladder outlet obstruction secondary to benign prostatic hyperplasia (BPH).
A total of 5 eligible male subjects aged 40 to 80 years with symptomatic BPH, International Prostate Symptom Score (IPSS) ≥13, maximum urinary flow rate (Qmax) of 5-10 mL/s, prostate volume <30 mL measured by TRUS, and evident bladder outlet obstruction will be enrolled. All subjects will undergo prostatic balloon dilation with the study device under real-time TRUS guidance. Follow-up assessments will be conducted at 1, 3, and 6 months after treatment.
The primary effectiveness endpoint is the change in IPSS from baseline at 1, 3, and 6 months. The primary safety endpoints include bladder neck contracture, retrograde ejaculation, device-related severe urinary retention persisting for more than 14 days after healing, new-onset stress urinary incontinence, device-related bleeding requiring transfusion, and device-related urethral or prostatic capsular rupture requiring surgical intervention.
Secondary endpoints include responder rates based on different thresholds of IPSS improvement (≥30%, ≥40%, and ≥50%), changes in Qmax, and changes in visual analogue scale (VAS) scores. Exploratory endpoints include changes in postvoid residual urine volume (PVR) and sexual function assessed by the International Index of Erectile Function (IIEF-5) and the Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD).
This exploratory study is intended to provide preliminary clinical evidence supporting the safety and potential clinical benefit of TRUS-guided ultra-minimally invasive prostatic dilation for BPH-related obstruction and to inform future larger-scale clinical studies.
Detailed description
This is a single-center, single-arm, prospective exploratory clinical study designed to preliminarily evaluate the safety and effectiveness of ultra-minimally invasive prostatic dilation using a dedicated prostate dilation catheter under real-time transrectal ultrasound (TRUS) guidance in patients with benign prostatic hyperplasia (BPH) associated with significant bladder outlet obstruction.
A total of 5 eligible male participants will be enrolled. Eligible subjects are 40 to 80 years of age, have moderate to severe lower urinary tract symptoms, an International Prostate Symptom Score (IPSS) of at least 13, a maximum urinary flow rate (Qmax) between 5 and 10 mL/s, and a prostate volume less than 30 mL as measured by TRUS. All participants must have clinically confirmed BPH with significant bladder outlet obstruction and preserved sexual function. Key exclusion criteria include suspected or confirmed malignancy, severe urinary tract infection, bleeding tendency, neurogenic bladder, and other conditions considered unsuitable for the procedure.
After providing written informed consent, each participant will undergo ultra-minimally invasive prostatic dilation with the study device under real-time TRUS guidance. The procedure is intended to be performed in a minimally invasive setting without the need for general anesthesia. Follow-up evaluations will be conducted at 1, 3, and 6 months after treatment.
Efficacy assessments will focus on changes from baseline in IPSS at 1, 3, and 6 months after the procedure. Safety assessments will include the occurrence of adverse events such as bladder neck contracture, retrograde ejaculation, device-related prolonged urinary retention lasting more than 14 days after healing, stress urinary incontinence, bleeding requiring transfusion, and urethral or prostatic capsular rupture requiring surgical intervention. Secondary outcomes include responder rates based on different thresholds of IPSS improvement, changes in Qmax and visual analogue scale (VAS) scores, and exploratory changes in postvoid residual urine volume (PVR) and sexual function parameters, including the International Index of Erectile Function-5 (IIEF-5) and the Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD).
This study is intended to generate preliminary clinical evidence regarding the safety and potential therapeutic benefit of TRUS-guided ultra-minimally invasive prostatic dilation for the treatment of BPH-related bladder outlet obstruction, and to support the design of future larger-scale clinical investigations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-center, single-arm, prospective exploratory study. All enrolled participants will receive TRUS-guided ultra-minimally invasive prostatic dilation using the investigational prostate dilation catheter. No control group or randomization is included.
| Arm | Type | Receives |
|---|---|---|
| TRUS-Guided Prostatic Dilation Group | Experimental | Device: Prostate Dilation CatheterParticipants in this arm will receive ultra-minimally invasive prostatic dilation using a dedicated prostate dilation catheter under real-time transrectal ultrasound guidance for the treatment of benign prostatic hyperplasia-associated bladder outlet obstruction. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male subjects aged 40 to 80 years with symptomatic benign prostatic hyperplasia (BPH) and obvious bladder outlet obstruction.
- Subjects with normal sexual life and a sexual partner, and with intact sexual function.
- International Prostate Symptom Score (IPSS) ≥ 13.
- Maximum urinary flow rate (Qmax) between 5 and 10 mL/s, with a minimum voided volume ≥ 150 mL.
- Prostate volume measured by transrectal ultrasound (TRUS) < 30 mL. Prostate volume is calculated as length × width × height × 0.52.
Key exclusion criteria (8 listed)
- Subjects who are unable or unwilling to sign the informed consent form (ICF) and/or comply with all follow-up requirements.
- Subjects who are unwilling to abstain from sexual activity or use protective sexual behavior within 90 days after treatment.
- Prostate-specific antigen (PSA) ≥ 10 ng/mL, unless prostate cancer has been excluded by biopsy.
- Confirmed or suspected prostate or bladder malignancy.
- Use of antiplatelet drugs, such as clopidogrel or aspirin, within 10 days before surgery, or planned use within 5 days after surgery.
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 |
|---|---|---|
| Prostate Dilation CatheterAlso: TRUS-guided ultra-minimally invasive prostatic dilationThe intervention consists of ultra-minimally invasive dilation of the prostatic urethra using a dedicated prostate dilation catheter under real-time transrectal ultrasound guidance. The treatment is designed to relieve bladder outlet obstruction caused by benign prostatic hyperplasia while preserving urinary and sexual function. | Device | TRUS-Guided Prostatic Dilation Group |
Primary outcome
Change in International Prostate Symptom Score from baseline to 3 months after treatment
Time frame: Baseline and 3 months after treatment
The International Prostate Symptom Score, or IPSS, will be used to evaluate lower urinary tract symptoms associated with benign prostatic hyperplasia. The score ranges from 0 to 35, with higher scores indicating more severe symptoms. The change in IPSS from baseline to 3 months after treatment will be assessed.
2 secondary outcomes
Change in maximum urinary flow rate from baseline to 3 months after treatment
Time frame: Baseline and 3 months after treatment
Incidence of treatment-related adverse events
Time frame: From treatment to 3 months after treatment
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 13 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because this is a small, single-center exploratory study and the data contain sensitive clinical information, including urological symptoms and sexual function assessments. To protect participant privacy and confidentiality, individual-level data will not be made available. Aggregate study results may be shared after completion of the study.
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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.
Qing Yuan principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prostate Dilation Catheter in people with BPH (Benign Prostatic Hyperplasia), run by Qing Yuan 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 8 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 13 May 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 (19917508192, rentangl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in International Prostate Symptom Score from baseline to 3 months after treatment (time frame: Baseline and 3 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2026.