Urethral Stricture, MaleNCT06192654
Small Intestinal Submucosa Graft for Repair of Anterior Urethral Strictures
A study testing Small intestinal submucosa (SIS) graft urethroplasty and Autologous oral bucal mucosa graft urethroplasty in people with Urethral Stricture, Male, run by Xiaoyong Zeng at 1 site in China.
Trial summary
The field of research for this study is tissue engineering and the utilization of a small intestinal submucosa graft as a substitute biomaterial for conventional buccal mucosa in substitution urethroplasty of anterior urethral strictures. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urethral Stricture, Male
- What is being tested?
- Small intestinal submucosa (SIS) graft urethroplasty and Autologous oral bucal mucosa graft urethroplasty
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2023to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients signed informed consent form
- Patients with a single, longer than 2.0 cm and shorter than or equal to 7.0 cm anterior urethral stricture
- Patients undergoing substitution urethroplasty for urethral stricture.
Who cannot join
- Patients without surgical indication
- Subtotal and total urethral strictures
- Radiation therapy to the abdomen or pelvis
- Lichen sclerosis related strictures
- Patients with previous hypospadias repair
- Neurogenic urinary tract disorders
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- Mental disorders
- Patients with a known biologic sensitivity or a cultural aversion to the use of porcine materials.
- Patients with severe dysfunction of heart, lung, liver, kidney and other important organs , endocrine system and blood system.
- Patient with malignant tumor
- Patient who cannot be regularly examined due to any circumstances
- Any clinical state which does not ensure the safe implementation of study procedure (investigator's view)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Small Intestinal Submucosa Graft as an Alternative to Conventional Buccal Mucosa for Substitution Urethroplasty of Anterior Urethral Strictures
The field of research for this study is tissue engineering and the utilization of a small intestinal submucosa graft as a substitute biomaterial for conventional buccal mucosa in substitution urethroplasty of anterior urethral strictures.
Read the detailed description
Urethral stricture refers to the abnormal narrowing of the urethral lumen resulting from fibrosis that affects the urethral epithelium and underlying corpus spongiosum. The management of urethral stricture longer than 2 cm a major therapeutic challenge in clinics. Currently available surgical techniques require harvesting of grafts from autologous sites. However, there are numerous disadvantages associated with autografts, such as limited availability and variable quality, donor site morbidity, increased risk of surgical complications; thereby the application of this method is especially limited for large defects.
The hypothesis of this study is that the small intestinal submucosa graft can be used as an alternative biomaterial to buccal mucosa for substitution urethroplasty in urethral stricture patients. The aim of this study is to assess safety and efficacy of surgical treatment of patients with anterior urethral stricture using a small intestinal submucosa graft. The follow-up time for all patients in this study was 5 years. The follow-up regimen includes retrograde and pericatheter urethrography, voiding cystourethrography, uroflowmetry, cystoscopy, and voiding symptoms monitoring. Telephone follow-up will take place in between these assessments.
- Conditions
- Urethral Stricture, Male
- Being tested
- Small intestinal submucosa (SIS) graft urethroplasty, Autologous oral bucal mucosa graft urethroplasty
- Keywords
- urethral stricture
- Medical subject headings
- Urethral Stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small intestinal submucosa (SIS) graft urethroplastyProcedure or surgery
Standard technique of doing a substitution urethroplasty with no modification to the surgical steps. Instead of an autologous oral bucal mucosa graft, the small intestinal submucosa graft is sutured to the healty urethral area after incision of the urethra at the stricture location.
Autologous oral bucal mucosa graft urethroplastyProcedure or surgery
Standard technique of doing a substitution urethroplasty with no modification to the surgical steps. The autologous oral bucal mucosa graft is sutured to the healty urethral area after incision of the urethra at the stricture location.
| Study group | Role | What they receive |
|---|---|---|
| Small intestinal submucosa (SIS) graft urethroplasty | Experimental | this group will use a small intestinal submucosa graft in urethroplasty. Receives: Procedure: Small intestinal submucosa (SIS) graft urethroplasty |
| Autologous oral bucal mucosa graft urethroplasty | Active comparator | this group will use an autologous oral bucal mucosa graft in urethroplasty. Receives: Procedure: Autologous oral bucal mucosa graft urethroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urethral patency
A peri-urethrogram will be performed prior to catheter removal
Measured: 4 weeks post-surgery
Secondary outcomes (4)
Serious adverse events
Frequency, type and severity of serious adverse events
Measured: 4 weeks post-surgery
Voiding symptoms
Participants are filling out the International Prostate Symptom Score (IPSS) questionnaire.
Measured: 2 months up-to 5 years post-surgery
Urine flow
Participants are undergoing an uroflowmetry. This test measures the volume of urine released from the body, the speed with which it is released, and how long the release takes.
Measured: 2 months up-to 5 years post-surgery
Anatomic recurrence of urethral stricture observed by cystoscopy 、 Retrograde urethrography(RUG)、 Voiding cystourethrography(VCUG)
Full assessment of the urethral lumen after the surgery
Measured: Through study completion, an average of up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start10 Nov 2023
- Primary completion20 Oct 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urethral Stricture, MaleStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaoyong Zeng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaoyong Zeng, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192654
- Sponsor's protocol ID
- NDXF-SIS
- Status last verified
- Dec 2023
- First submitted
- 21 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Intestinal Submucosa Graft as an Alternative to Conventional Buccal Mucosa for Substitution Urethroplasty of Anterior Urethral Strictures
- ClinicalTrials.gov ID
- NCT06192654
- Acronym / sponsor ID
- NDXF-SIS
- Conditions
- Urethral Stricture, Male
- Keywords
- urethral stricture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Xiaoyong ZengUniversity, hospital or other
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 20 Oct 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 5 Jan 2024 (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.
The field of research for this study is tissue engineering and the utilization of a small intestinal submucosa graft as a substitute biomaterial for conventional buccal mucosa in substitution urethroplasty of anterior urethral strictures.
Detailed description
Urethral stricture refers to the abnormal narrowing of the urethral lumen resulting from fibrosis that affects the urethral epithelium and underlying corpus spongiosum. The management of urethral stricture longer than 2 cm a major therapeutic challenge in clinics. Currently available surgical techniques require harvesting of grafts from autologous sites. However, there are numerous disadvantages associated with autografts, such as limited availability and variable quality, donor site morbidity, increased risk of surgical complications; thereby the application of this method is especially limited for large defects.
The hypothesis of this study is that the small intestinal submucosa graft can be used as an alternative biomaterial to buccal mucosa for substitution urethroplasty in urethral stricture patients. The aim of this study is to assess safety and efficacy of surgical treatment of patients with anterior urethral stricture using a small intestinal submucosa graft. The follow-up time for all patients in this study was 5 years. The follow-up regimen includes retrograde and pericatheter urethrography, voiding cystourethrography, uroflowmetry, cystoscopy, and voiding symptoms monitoring. Telephone follow-up will take place in between these assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Small intestinal submucosa (SIS) graft urethroplasty | Experimental | Procedure: Small intestinal submucosa (SIS) graft urethroplastythis group will use a small intestinal submucosa graft in urethroplasty. |
| Autologous oral bucal mucosa graft urethroplasty | Active comparator | Procedure: Autologous oral bucal mucosa graft urethroplastythis group will use an autologous oral bucal mucosa graft in urethroplasty. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients signed informed consent form
- Patients with a single, longer than 2.0 cm and shorter than or equal to 7.0 cm anterior urethral stricture
- Patients undergoing substitution urethroplasty for urethral stricture.
Key exclusion criteria (12 listed)
- Patients without surgical indication
- Subtotal and total urethral strictures
- Radiation therapy to the abdomen or pelvis
- Lichen sclerosis related strictures
- Patients with previous hypospadias repair
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 |
|---|---|---|
| Small intestinal submucosa (SIS) graft urethroplastyStandard technique of doing a substitution urethroplasty with no modification to the surgical steps. Instead of an autologous oral bucal mucosa graft, the small intestinal submucosa graft is sutured to the healty urethral area after incision of the urethra at the stricture location. | Procedure or surgery | Small intestinal submucosa (SIS) graft urethroplasty |
| Autologous oral bucal mucosa graft urethroplastyStandard technique of doing a substitution urethroplasty with no modification to the surgical steps. The autologous oral bucal mucosa graft is sutured to the healty urethral area after incision of the urethra at the stricture location. | Procedure or surgery | Autologous oral bucal mucosa graft urethroplasty |
Primary outcome
Urethral patency
Time frame: 4 weeks post-surgery
A peri-urethrogram will be performed prior to catheter removal
4 secondary outcomes
Serious adverse events
Time frame: 4 weeks post-surgery
Voiding symptoms
Time frame: 2 months up-to 5 years post-surgery
Urine flow
Time frame: 2 months up-to 5 years post-surgery
Anatomic recurrence of urethral stricture observed by cystoscopy 、 Retrograde urethrography(RUG)、 Voiding cystourethrography(VCUG)
Time frame: Through study completion, an average of up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
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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. This study is not recruiting at the moment.
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 Small intestinal submucosa (SIS) graft urethroplasty and Autologous oral bucal mucosa graft urethroplasty in people with Urethral Stricture, Male, run by Xiaoyong Zeng 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 3 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: status not confirmed, as of the sponsor's last update on 5 Jan 2024. 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?
Results are not available in the source record.
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?
Urethral patency (time frame: 4 weeks post-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 5 Jan 2024.