Ureteral StenosisPGU20240101NCT07408050
An Investigation Into the Application of Preputial Grafts for the Reconstruction of Complex Ureteral Strictures
A study testing Preputial graft ureteroplasty in people with Ureteral Stenosis, run by Ruibao chen at 1 site in China.
Trial summary
Complex ureteral stricture refers to a ureteral lumen stenosis lesion that cannot be directly treated with the traditional end-to-end anastomosis. In recent years, its incidence has shown a gradual upward trend, and it has long been a major clinical challenge for urological surgeons. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Ureteral Stenosis
- What is being tested?
- Preputial graft ureteroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 5 Feb 2026to 1 Jan 2032
- 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 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients over 18 years of age.
- Preoperative assessment confirming complex ureteral strictures, characterized by ureteral luminal stenosis that cannot be addressed via conventional end-to-end anastomosis. Patients were deemed ineligible for existing surgical. interventions such as pyeloureteroplasty, ureteral end-to-end anastomosis, and ureteroneocystostomy.
- Ability to undergo minimally invasive laparoscopic surgery for ureteral stricture repair.
- Presence of redundant prepuce or availability of an inner preputial flap for graft harvesting.
- Capacity for independent decision-making and willingness to voluntarily sign the informed consent form for study participation.
Who cannot join
- Presence of surgical contraindications.
- History of abdominal radiotherapy.
- Ureteral strictures resulting from malignant tumors.
- An Eastern Cooperative Oncology Group (ECOG) performance status score greater than 2.
- Poor compliance or other exclusion criteria as determined 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
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: A Study on the Reconstruction of Complex Ureteral Stenosis Utilizing Preputial Grafts.
Complex ureteral stricture refers to a ureteral lumen stenosis lesion that cannot be directly treated with the traditional end-to-end anastomosis. In recent years, its incidence has shown a gradual upward trend, and it has long been a major clinical challenge for urological surgeons. Because it is difficult to achieve tension-free anastomosis after direct resection of the strictured segment, which can easily lead to the failure of stricture repair surgery, simple ureteral stricture segment resection combined with end-to-end anastomosis is generally not recommended for the treatment of such diseases.
In general, clinicians need to select alternative materials for ureteral reconstruction, such as Boari flap, appendix, intestinal tract, and oral mucosa, to achieve the surgical effect of tension-free anastomosis. However, in some complex clinical cases, if Boari flap, appendix, intestinal tract or oral mucosa cannot be used for surgery, or if patients refuse to accept oral mucosa, intestinal mucosa and other tissues for ureteral repair, are there any other alternative schemes with high safety and minimal invasiveness available for ureteral reconstruction in clinical practice? Thus, it is of great clinical significance to develop safe, effective and innovative surgical techniques for ureteral reconstruction. Circumcision is a surgical procedure with a long history and wide application, and the prepuce removed during the operation is usually treated as medical waste. Our research team has previously performed a large number of surgeries using prepuce to repair the urethra. Clinical results have shown that free prepuce has the advantages of easy survival, convenient harvesting and minimal invasiveness, making it an ideal graft material for urinary tract repair and reconstruction.
At present, there have been case reports on ureteral reconstruction using prepuce abroad. Based on our team's previous research experience in the fields of urethral reconstruction and ureteral reconstruction, the investigators intend to carry out relevant research on ureteral reconstruction with free preputial grafts, aiming to obtain convincing clinical data and provide a more minimally invasive and safer new treatment option for the repair and reconstruction of complex ureteral strictures.
- Conditions
- Ureteral Stenosis
- Being tested
- Preputial graft ureteroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preputial graft ureteroplastyProcedure or surgery
Reconstruction of complex ureteral stenosis using preputial graft
| Study group | Role | What they receive |
|---|---|---|
| Patients with complex ureteral stenosis undergoing PGU surgery | Experimental | After enrolling patients with complex ureteral stenosis, PGU surgery was performed, and postoperative follow-up was conducted to assess complications, renal hydronephrosis, and renal function recovery. Receives: Procedure: Preputial graft ureteroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ureteral patency
The alteration in eGFR, denoted as ΔeGFR, was employed to evaluate changes in renal function. The calculation for ΔeGFR is as follows: ΔeGFR = (postoperative eGFR - preoperative eGFR) / preoperative eGFR. Renal ultrasound, computed tomography (CT), and magnetic resonance urography (MRU) are utilized to measure the anteroposterior diameter (APD) and indirectly assess ureteral patency.
Measured: From surgery to 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 posted12 Feb 2026
- Study start5 Feb 2026
- Primary completion1 Jan 2031 (estimated)
- Study completion1 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral StenosisStudies 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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruibao chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ruibao chen, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07408050
- Sponsor's protocol ID
- TJ-IRB202505033
- Other IDs
- MR-42-25-056915
- Acronym
- PGU20240101
- Status last verified
- Sep 2026
- First submitted
- 27 Jan 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: International Committee of Medical Journal Editors
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Reconstruction of Complex Ureteral Stenosis Utilizing Preputial Grafts.
- ClinicalTrials.gov ID
- NCT07408050
- Acronym / sponsor ID
- PGU20240101 / TJ-IRB202505033
- Conditions
- Ureteral Stenosis
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ruibao chenUniversity, hospital or other
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 1 Jan 2031 (estimated)
- Study completion
- 1 Jan 2032 (estimated)
- First posted
- 12 Feb 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.
Complex ureteral stricture refers to a ureteral lumen stenosis lesion that cannot be directly treated with the traditional end-to-end anastomosis. In recent years, its incidence has shown a gradual upward trend, and it has long been a major clinical challenge for urological surgeons. Because it is difficult to achieve tension-free anastomosis after direct resection of the strictured segment, which can easily lead to the failure of stricture repair surgery, simple ureteral stricture segment resection combined with end-to-end anastomosis is generally not recommended for the treatment of such diseases.
In general, clinicians need to select alternative materials for ureteral reconstruction, such as Boari flap, appendix, intestinal tract, and oral mucosa, to achieve the surgical effect of tension-free anastomosis. However, in some complex clinical cases, if Boari flap, appendix, intestinal tract or oral mucosa cannot be used for surgery, or if patients refuse to accept oral mucosa, intestinal mucosa and other tissues for ureteral repair, are there any other alternative schemes with high safety and minimal invasiveness available for ureteral reconstruction in clinical practice? Thus, it is of great clinical significance to develop safe, effective and innovative surgical techniques for ureteral reconstruction. Circumcision is a surgical procedure with a long history and wide application, and the prepuce removed during the operation is usually treated as medical waste. Our research team has previously performed a large number of surgeries using prepuce to repair the urethra. Clinical results have shown that free prepuce has the advantages of easy survival, convenient harvesting and minimal invasiveness, making it an ideal graft material for urinary tract repair and reconstruction.
At present, there have been case reports on ureteral reconstruction using prepuce abroad. Based on our team's previous research experience in the fields of urethral reconstruction and ureteral reconstruction, the investigators intend to carry out relevant research on ureteral reconstruction with free preputial grafts, aiming to obtain convincing clinical data and provide a more minimally invasive and safer new treatment option for the repair and reconstruction of complex ureteral strictures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with complex ureteral stenosis undergoing PGU surgery | Experimental | Procedure: Preputial graft ureteroplastyAfter enrolling patients with complex ureteral stenosis, PGU surgery was performed, and postoperative follow-up was conducted to assess complications, renal hydronephrosis, and renal function recovery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male patients over 18 years of age.
- Preoperative assessment confirming complex ureteral strictures, characterized by ureteral luminal stenosis that cannot be addressed via conventional end-to-end anastomosis. Patients were deemed ineligible for existing surgical. interventions such as pyeloureteroplasty, ureteral end-to-end anastomosis, and ureteroneocystostomy.
- Ability to undergo minimally invasive laparoscopic surgery for ureteral stricture repair.
- Presence of redundant prepuce or availability of an inner preputial flap for graft harvesting.
- Capacity for independent decision-making and willingness to voluntarily sign the informed consent form for study participation.
Key exclusion criteria (5 listed)
- Presence of surgical contraindications.
- History of abdominal radiotherapy.
- Ureteral strictures resulting from malignant tumors.
- An Eastern Cooperative Oncology Group (ECOG) performance status score greater than 2.
- Poor compliance or other exclusion criteria as determined by the investigators.
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 |
|---|---|---|
| Preputial graft ureteroplastyReconstruction of complex ureteral stenosis using preputial graft | Procedure or surgery | Patients with complex ureteral stenosis undergoing PGU surgery |
Primary outcome
Ureteral patency
Time frame: From surgery to 6 months after surgery
The alteration in eGFR, denoted as ΔeGFR, was employed to evaluate changes in renal function. The calculation for ΔeGFR is as follows: ΔeGFR = (postoperative eGFR - preoperative eGFR) / preoperative eGFR. Renal ultrasound, computed tomography (CT), and magnetic resonance urography (MRU) are utilized to measure the anteroposterior diameter (APD) and indirectly assess ureteral patency.
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 30 Sep 2026.
- Individual participant dataSharing planned: Yes. International Committee of Medical Journal Editors
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preputial graft ureteroplasty in people with Ureteral Stenosis, run by Ruibao chen 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 5 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: enrolling by invitation, as of the sponsor's last update on 30 Sep 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ureteral patency (time frame: From surgery to 6 months after surgery). 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 30 Sep 2026.