Lower Urinary Tract SymptomsEarly Phase 1NCT07447518
Double j Stent Related Symptoms
A Early Phase 1 study testing Tadalafil 5mg, solidosin and Solfenacin in people with Lower Urinary Tract Symptoms, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
In urology, ureteral stents are used to treat obstructive diseases. Hematuria (54%), fever, discomfort, and lower urinary system symptoms are the predominant symptoms related to ureteral stent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Urinary Tract Symptoms
- What is being tested?
- Tadalafil 5mg, solidosin and Solfenacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 535 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Sep 2022to 1 Sep 2023
- Phase
- Early Phase 1
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age above 18 years
- any patient need post urs or pcnl double stent
Who cannot join
- age less than 18 years
- known over active bladder patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Mirabegron ,Tamsulosin and Solifenacinin Relieving Double -J Stent Related Symptoms : Approspective Randmized Placebo Controlledtrial
In urology, ureteral stents are used to treat obstructive diseases. Hematuria (54%), fever, discomfort, and lower urinary system symptoms are the predominant symptoms related to ureteral stent.
- Conditions
- Lower Urinary Tract Symptoms
- Being tested
- Tadalafil 5mg, solidosin, Solfenacin, Mirabegron, Placebo
- Keywords
- LUTS, Double j
- Medical subject headings
- Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tadalafil 5mgDrug
once daily 5mg
solidosinDrug
once daily
SolfenacinDrug
once dialy
MirabegronDrug
once daily
PlaceboDrug
once daily
| Study group | Role | What they receive |
|---|---|---|
| Group A : patients will receive tadalafil | Active comparator | Not described Receives: Drug: Tadalafil 5mg |
| Group B: patients will receive solidosin | Active comparator | Not described Receives: Drug: solidosin |
| Group C: patients will receive solfenacin | Active comparator | Not described Receives: Drug: Solfenacin |
| Group D: patients will receive mirabegron | Active comparator | Not described Receives: Drug: Mirabegron |
| Group E: patients will receive placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Double j related symptoms
Double j related symptoms questionnaire score
Measured: Six weeks
Secondary outcomes (1)
Sex matters related double j stent
Sex matters related stent
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start22 Sep 2022
- Primary completion1 Jan 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 535 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elsayed Abdelhalim Elsayed, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447518
- Sponsor's protocol ID
- 35806/9/22
- Status last verified
- Feb 2026
- First submitted
- 17 Jan 2025
- Last updated
- 3 Mar 2026
- 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 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Mirabegron ,Tamsulosin and Solifenacinin Relieving Double -J Stent Related Symptoms : Approspective Randmized Placebo Controlledtrial
- ClinicalTrials.gov ID
- NCT07447518
- Acronym / sponsor ID
- 35806/9/22
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- LUTS, Double j
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 535 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 3 Mar 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.
In urology, ureteral stents are used to treat obstructive diseases. Hematuria (54%), fever, discomfort, and lower urinary system symptoms are the predominant symptoms related to ureteral stent.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A : patients will receive tadalafil | Active comparator | Drug: Tadalafil 5mg |
| Group B: patients will receive solidosin | Active comparator | Drug: solidosin |
| Group C: patients will receive solfenacin | Active comparator | Drug: Solfenacin |
| Group D: patients will receive mirabegron | Active comparator | Drug: Mirabegron |
| Group E: patients will receive placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age above 18 years
- any patient need post urs or pcnl double stent
Key exclusion criteria (2 listed)
- age less than 18 years
- known over active bladder patient
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 |
|---|---|---|
| Tadalafil 5mgonce daily 5mg | Drug | Group A : patients will receive tadalafil |
| solidosinonce daily | Drug | Group B: patients will receive solidosin |
| Solfenacinonce dialy | Drug | Group C: patients will receive solfenacin |
| Mirabegrononce daily | Drug | Group D: patients will receive mirabegron |
| Placeboonce daily | Drug | Group E: patients will receive placebo |
Primary outcome
Double j related symptoms
Time frame: Six weeks
Double j related symptoms questionnaire score
1 secondary outcome
Sex matters related double j stent
Time frame: Six weeks
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 3 Mar 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 Early Phase 1 study testing Tadalafil 5mg, solidosin and Solfenacin in people with Lower Urinary Tract Symptoms, run by Kafrelsheikh 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 2 inclusion and 2 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 3 Mar 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Double j related symptoms (time frame: Six weeks). 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 3 Mar 2026.