Stricture UrethraPhase 3prp vs VIUNCT07837167
The Effect of Platelet Rich Plasma Injection on Post Internal Urethrotomy Stricture Recurrence
A Phase 3 study testing PRP injection and VIU in people with Stricture Urethra, run by Benha University at 1 site in Egypt.
Trial summary
The effect of platelet rich plasma injection on post internal urethrotomy stricture recurrence Read more about this study
- Who is it for?
- Ages 20 to 50 years, men only
- Conditions the study is for
- Stricture Urethra
- What is being tested?
- PRP injection and VIU
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Feb 2024to 19 Mar 2026
- Phase
- Phase 3
- 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 20 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- patients with symptomatic bulbar urethral stricture (diagnosed by retrograde urethrography) aged between 20 and 50 years.
Who cannot join
- History or medical evidence of symptomatic benign prostatic enlargement.
- documented or suspicious prostate cancer.
- history of hypospadias, neurogenic disorders.
- previous internal urethrotomy or urethral reconstruction.
- strictures longer than 1.5 cm.
- multiple strictures.
Trial locations and contacts
1 site in 1 country.
About this study
The effect of platelet rich plasma injection on post internal urethrotomy stricture recurrence
- Conditions
- Stricture Urethra
- Being tested
- PRP injection, VIU
- Medical subject headings
- Urethral Stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP injectionDrug
The effect of platelet rich plasma injection on post internal urethrotomy stricture recurrence
VIUProcedure or surgery
VIU in stricture urethra
| Study group | Role | What they receive |
|---|---|---|
| PRP in stricture urethra | Active comparator | Not described Receives: Drug: PRP injection |
| viu in stricture urethra | Placebo comparator | Not described Receives: Procedure: VIU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-voiding residual urine volume (PVR)
Post-voiding residual urine volume will be measured by ultrasonography , Unit of Measure : ml .
Measured: 2 weeks
Maximum urinary flow rate (Qmax)
Maximum urinary flow rate will be assessed by uroflowmetry , Unit of Measure : ml/second
Measured: 2 weeks
Secondary outcomes (1)
recurrence of stricture urethra
recurrence of stricture urethra measured by ascending urethrogram and uroflowmetry
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start19 Feb 2024
- Primary completion19 Feb 2025
- Study completion19 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stricture UrethraStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Ali Mahmoud, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837167
- Sponsor's protocol ID
- RC 19-2-2025
- Acronym
- prp vs VIU
- Status last verified
- Feb 2025
- First submitted
- 12 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Platelet Rich Plasma Injection on Post Internal Urethrotomy Stricture Recurrence
- ClinicalTrials.gov ID
- NCT07837167
- Acronym / sponsor ID
- prp vs VIU / RC 19-2-2025
- Conditions
- Stricture Urethra
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 19 Feb 2025 (actual)
- Study completion
- 19 Mar 2026 (actual)
- First posted
- 23 Sep 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.
The effect of platelet rich plasma injection on post internal urethrotomy stricture recurrence
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP in stricture urethra | Active comparator | Drug: PRP injection |
| viu in stricture urethra | Placebo comparator | Procedure: VIU |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with symptomatic bulbar urethral stricture (diagnosed by retrograde urethrography) aged between 20 and 50 years.
Key exclusion criteria (6 listed)
- History or medical evidence of symptomatic benign prostatic enlargement.
- documented or suspicious prostate cancer.
- history of hypospadias, neurogenic disorders.
- previous internal urethrotomy or urethral reconstruction.
- strictures longer than 1.5 cm.
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 |
|---|---|---|
| PRP injectionThe effect of platelet rich plasma injection on post internal urethrotomy stricture recurrence | Drug | PRP in stricture urethra |
| VIUVIU in stricture urethra | Procedure or surgery | viu in stricture urethra |
Primary outcome
Post-voiding residual urine volume (PVR)
Time frame: 2 weeks
Post-voiding residual urine volume will be measured by ultrasonography , Unit of Measure : ml .
Maximum urinary flow rate (Qmax)
Time frame: 2 weeks
Maximum urinary flow rate will be assessed by uroflowmetry , Unit of Measure : ml/second
1 secondary outcome
recurrence of stricture urethra
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
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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 Phase 3 study testing PRP injection and VIU in people with Stricture Urethra, run by Benha University at 1 site in Egypt.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 23 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 Egypt. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Post-voiding residual urine volume (PVR) (time frame: 2 weeks). The study lists 2 primary outcomes in all. 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 23 Sep 2026.