Ureteric Stent-related MorbidityNCT07307261
Evaluation of Mirabegron Versus Tamsulosin or Their Combination in Treatment of Lower Urinary Tract Symptoms
A study testing Tamsulosin in people with Ureteric Stent-related Morbidity, run by Avraiem Talaat at 1 site in Egypt.
Trial summary
Stent related symptoms (SRSs) comprise of complaints such as irritative symptoms, sense of incomplete emptying, flank and suprapubic pain, and incontinence. Mechanical irritation of trigone, urinary reflux, and stent movement are plausible causes for SRSs. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Ureteric Stent-related Morbidity
- What is being tested?
- Tamsulosin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2024to 10 Oct 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- First time to use Ureteric stent .
Who cannot join
- Urinary tract infection.
- Previous ureteral surgery.
- Congenital malformation of the ureter.
- Distal ureteric stricture.
- Hypersensitivity to the drugs.
- Pregnancy or lactation.
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- Hepatic insufficiency
- Non-compliant patients.
- Age < 18 years old .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Mirabegron Versus Tamsulosin or Their Combination in Treatment of Lower Urinary Tract Symptoms Related to Double j Stent in Adults: A Prospective Randomized Study
Stent related symptoms (SRSs) comprise of complaints such as irritative symptoms, sense of incomplete emptying, flank and suprapubic pain, and incontinence. Mechanical irritation of trigone, urinary reflux, and stent movement are plausible causes for SRSs.
Alpha-blockers are the primary medications for ureteral stent-related symptoms. These medications are suggested to patients by the American Urological Association (AUA)/Endourological Society guideline to reduce stent-related symptoms with moderate recommendation. Nevertheless, there are many side effects associated with alpha-blockers such as dizziness, headache, and orthostatic hypotension
Read the detailed description
Ureteral stents have become an important part of urologic practice since first described the double-J stent . most often urolithiasis. Their use may be associated with significant bothersome symptoms and discomfort. Ureteral stent-related symptoms (SRSs) may occur in up to 88% of patients in mild or more severe degree.
Mirabegron is the first and only selective β3-adrenergic receptor agonist agent currently available and it is one of the treatment options for overactive bladder (OAB). Hence, many urologists have been introducing mirabegron therapy for OAB in recent years and because the SRS are similar to OAB symptoms, it may be another treatment option for reducing bladder irritability in patients indwelling DJ stent.
It is currently unclear whether mirabegron has a place in the treatment of SRSs. Our study aims to systematically evaluate the efficacy and safety of mirabegron in treating SRSs in comparison to Tamsulosin and their combination in adult patients
- Conditions
- Ureteric Stent-related Morbidity
- Being tested
- Tamsulosin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamsulosinDrug
Also called Mirabegron
to compare the effect of mirabegron and tamsulosin and their combination on ureteric stent-related morbidity
| Study group | Role | What they receive |
|---|---|---|
| Tamsulosin 0.4mg | Active comparator | About 100 patients will receive Tamsulosin (0.4mg) once daily for 3 weeks for the treatment of lower urinary tract symptoms related to double j stent in adults Receives: Drug: Tamsulosin |
| Mirabegron 50mg | Active comparator | About 100 patients will receive Mirabegron (50mg) once daily for 3 weeks for the treatment of lower urinary tract symptoms related to double j stent in adults Receives: Drug: Tamsulosin |
| combination of tamsulosin 0.4mg and Mirabegron 50mg | Active comparator | About 100 patients will receive A combination of tamsulosin (0.4mg) and Mirabegron (50mg) once daily for 3 weeks for the treatment of lower urinary tract symptoms related to double j stent in adults Receives: Drug: Tamsulosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment of Ureteral Stent Pain
All patients will be evaluated before and after the treatment from the pain by the visual analog pain scale..
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start10 Oct 2024
- Primary completion5 Oct 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteric Stent-related MorbidityStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avraiem Talaat
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Avraiem Talaat, South Valley University
- Investigators
- Mohammad Sayed Abdel-kader, Professor, Study chair, Urology Department,faculty of Medicine, South Valley university.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307261
- Sponsor's protocol ID
- Mirabegron Vs Tamsulosin
- Status last verified
- Oct 2024
- First submitted
- 19 Jan 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mirabegron Versus Tamsulosin or Their Combination in Treatment of Lower Urinary Tract Symptoms Related to Double j Stent in Adults: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT07307261
- Acronym / sponsor ID
- Mirabegron Vs Tamsulosin
- Conditions
- Ureteric Stent-related Morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Avraiem TalaatUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 5 Oct 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 29 Dec 2025 (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.
Stent related symptoms (SRSs) comprise of complaints such as irritative symptoms, sense of incomplete emptying, flank and suprapubic pain, and incontinence. Mechanical irritation of trigone, urinary reflux, and stent movement are plausible causes for SRSs.
Alpha-blockers are the primary medications for ureteral stent-related symptoms. These medications are suggested to patients by the American Urological Association (AUA)/Endourological Society guideline to reduce stent-related symptoms with moderate recommendation. Nevertheless, there are many side effects associated with alpha-blockers such as dizziness, headache, and orthostatic hypotension
Detailed description
Ureteral stents have become an important part of urologic practice since first described the double-J stent . most often urolithiasis. Their use may be associated with significant bothersome symptoms and discomfort. Ureteral stent-related symptoms (SRSs) may occur in up to 88% of patients in mild or more severe degree.
Mirabegron is the first and only selective β3-adrenergic receptor agonist agent currently available and it is one of the treatment options for overactive bladder (OAB). Hence, many urologists have been introducing mirabegron therapy for OAB in recent years and because the SRS are similar to OAB symptoms, it may be another treatment option for reducing bladder irritability in patients indwelling DJ stent.
It is currently unclear whether mirabegron has a place in the treatment of SRSs. Our study aims to systematically evaluate the efficacy and safety of mirabegron in treating SRSs in comparison to Tamsulosin and their combination in adult patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin 0.4mg | Active comparator | Drug: TamsulosinAbout 100 patients will receive Tamsulosin (0.4mg) once daily for 3 weeks for the treatment of lower urinary tract symptoms related to double j stent in adults |
| Mirabegron 50mg | Active comparator | Drug: TamsulosinAbout 100 patients will receive Mirabegron (50mg) once daily for 3 weeks for the treatment of lower urinary tract symptoms related to double j stent in adults |
| combination of tamsulosin 0.4mg and Mirabegron 50mg | Active comparator | Drug: TamsulosinAbout 100 patients will receive A combination of tamsulosin (0.4mg) and Mirabegron (50mg) once daily for 3 weeks for the treatment of lower urinary tract symptoms related to double j stent in adults |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- First time to use Ureteric stent .
Key exclusion criteria (9 listed)
- Urinary tract infection.
- Previous ureteral surgery.
- Congenital malformation of the ureter.
- Distal ureteric stricture.
- Hypersensitivity to the drugs.
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 |
|---|---|---|
| TamsulosinAlso: Mirabegronto compare the effect of mirabegron and tamsulosin and their combination on ureteric stent-related morbidity | Drug | Mirabegron 50mg, Tamsulosin 0.4mg, combination of tamsulosin 0.4mg and Mirabegron 50mg |
Primary outcome
Treatment of Ureteral Stent Pain
Time frame: 4 Weeks
All patients will be evaluated before and after the treatment from the pain by the visual analog pain scale..
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 29 Dec 2025.
- Individual participant dataSharing planned: Undecided
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.
Mohammad Sayed Abdel-kader, Professor study chair
Urology Department,faculty of Medicine, South Valley university.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tamsulosin in people with Ureteric Stent-related Morbidity, run by Avraiem Talaat 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 9 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 29 Dec 2025. 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. 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?
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?
Treatment of Ureteral Stent Pain (time frame: 4 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 29 Dec 2025.