Ureteral Stent-Related SymptomPhase 3NCT06803030
Study of Tamsulosin, Solifenacin and Mirabegron in Alleviating Ureteral Stent-related Symptoms
A Phase 3 study testing Tamsulosin Hydrochloride 0.4 mg, Solifenacin Succinate 5 mg and Mirabegron 25 mg in people with Ureteral Stent-Related Symptom, run by Bir Hospital at 1 site in Nepal.
Trial summary
A comparative study on the efficacy of Tamsulosin, Solifenacin and Mirabegron in alleviating ureteral stent-related symptoms: a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ureteral Stent-Related Symptom
- What is being tested?
- Tamsulosin Hydrochloride 0.4 mg, Solifenacin Succinate 5 mg and Mirabegron 25 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteNepal
- Study dates
- 30 Aug 2025to 31 Dec 2026
- Phase
- Phase 3
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible participants were adult patients (aged 19-80 years) who underwent unilateral retrograde rigid ureteroscopy (URS) or retrograde intrarenal surgery (RIRS) with planned ureteric stent insertion for urinary tract stones
Who cannot join
- Concomitant use of a-blockers, anticholinergics, corticosteroids, calcium channel blockers, and analgesics
- Undergoing percutaneous nephrolithotomy, open ureteric surgery or laparoscopic ureteric surgery, including ureterolithotomy
- Neurogenic bladder, Over Active Bladder (OAB) syndrome, and neurological and psychiatric diseases
- Preoperative febrile Urinary Tract Infection (UTI)
- Pregnancy or breastfeeding;
- A single kidney
Show all 12Show fewer
- Moderate or severe cardiovascular or cerebrovascular disease
- Hepatic dysfunction
- History of pelvic surgery or irradiation
- History of bladder or prostate surgery
- Other acute medical conditions (including acute pancreatitis, acute gastroenteritis, musculoskeletal disorders) that might influence the Ureteral Stent Symptom Questionnaire(USSQ) pain score
- Allergy to any medication
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nepal1 site, 1 recruiting
- Recruiting
NAMS, Bir Hospital
Kathmandu, Bagmati, 44600
Jainendra K Manoj, Dr, 9841529629, drjkmanoj@gmail.com
About this study
Official title: A Comparative Study on the Efficacy of Tamsulosin, Solifenacin and Mirabegron in Alleviating Ureteral Stent-related Symptoms: a Randomized Controlled Trial
A comparative study on the efficacy of Tamsulosin, Solifenacin and Mirabegron in alleviating ureteral stent-related symptoms: a randomized controlled trial.
Read the detailed description
Ureteral stent related symptoms can be a major issue in patient undergoing stent placement after any procedure such as- complains of pain, urinary symptoms, sex related and work related and other symptoms. These symptoms can be alleviated with use of drugs such as Tamsulosin, Solifenacin and Mirabegron. Patient recruited in each arm of the study will have their stent related symptoms scoring done using a validated outcome assessment tool to measure the ureteral stent-related symptoms, Ureteral Stent Symptom Questionnaire (USSQ) on day 1, day 7 and day 14 after the stent placement.
- Conditions
- Ureteral Stent-Related Symptom
- Being tested
- Tamsulosin Hydrochloride 0.4 mg, Solifenacin Succinate 5 mg, Mirabegron 25 mg
- Keywords
- Mirabegron, Tamsulosin, Solifenacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamsulosin Hydrochloride 0.4 mgDrug
Also called Cap. Urimax 0.4 mg
placement of ureteral stents followed by Cap. Tamsulosin 0.4 mg once daily
Solifenacin Succinate 5 mgDrug
Also called Tab. Solay 5 mg
placement of ureteral stents followed by Tab. Solifenacin 5 mg once daily
Mirabegron 25 mgDrug
Also called Tab. Mirasin 25 mg
placement of ureteral stents followed by Tab. Mirabegron 25 mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Tamsulosin group | Active comparator | placement of ureteral stents followed by Cap. Tamsulosin 0.4 mg once daily, to relieve the symptom Receives: Drug: Tamsulosin Hydrochloride 0.4 mg |
| Solifenacin group | Active comparator | placement of ureteral stents followed by Tab Solifenacin 5 mg once daily, to relieve the symptom Receives: Drug: Solifenacin Succinate 5 mg |
| Mirabegron group | Active comparator | placement of ureteral stents followed by Tab. Mirabegron 25 mg once daily, to relieve the symptom Receives: Drug: Mirabegron 25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
alleviating Ureteral stent related symptoms
mitigating the ureteric stent related symptoms using structured questionnaire
Measured: 2 weeks
Secondary outcomes (1)
early removal of ureteral stent
early removal of stent due to stent migration, fever, urosepsis
Measured: before 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start30 Aug 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral Stent-Related SymptomStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 189 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bir Hospital
- Sponsor type
- Other government
- Collaborators
- Nepal Health Research Council
- Responsible party
- Principal investigator, Jainendra Kumar Manoj, Bir Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803030
- Sponsor's protocol ID
- BirH
- Status last verified
- Aug 2025
- First submitted
- 27 Jan 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study on the Efficacy of Tamsulosin, Solifenacin and Mirabegron in Alleviating Ureteral Stent-related Symptoms: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06803030
- Acronym / sponsor ID
- BirH
- Conditions
- Ureteral Stent-Related Symptom
- Keywords
- Mirabegron, Tamsulosin, Solifenacin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- Bir HospitalOther government
- Collaborators
- Nepal Health Research Council
- Study start
- 30 Aug 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Jan 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.
A comparative study on the efficacy of Tamsulosin, Solifenacin and Mirabegron in alleviating ureteral stent-related symptoms: a randomized controlled trial.
Detailed description
Ureteral stent related symptoms can be a major issue in patient undergoing stent placement after any procedure such as- complains of pain, urinary symptoms, sex related and work related and other symptoms. These symptoms can be alleviated with use of drugs such as Tamsulosin, Solifenacin and Mirabegron. Patient recruited in each arm of the study will have their stent related symptoms scoring done using a validated outcome assessment tool to measure the ureteral stent-related symptoms, Ureteral Stent Symptom Questionnaire (USSQ) on day 1, day 7 and day 14 after the stent placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin group | Active comparator | Drug: Tamsulosin Hydrochloride 0.4 mgplacement of ureteral stents followed by Cap. Tamsulosin 0.4 mg once daily, to relieve the symptom |
| Solifenacin group | Active comparator | Drug: Solifenacin Succinate 5 mgplacement of ureteral stents followed by Tab Solifenacin 5 mg once daily, to relieve the symptom |
| Mirabegron group | Active comparator | Drug: Mirabegron 25 mgplacement of ureteral stents followed by Tab. Mirabegron 25 mg once daily, to relieve the symptom |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible participants were adult patients (aged 19-80 years) who underwent unilateral retrograde rigid ureteroscopy (URS) or retrograde intrarenal surgery (RIRS) with planned ureteric stent insertion for urinary tract stones
Key exclusion criteria (12 listed)
- Concomitant use of a-blockers, anticholinergics, corticosteroids, calcium channel blockers, and analgesics
- Undergoing percutaneous nephrolithotomy, open ureteric surgery or laparoscopic ureteric surgery, including ureterolithotomy
- Neurogenic bladder, Over Active Bladder (OAB) syndrome, and neurological and psychiatric diseases
- Preoperative febrile Urinary Tract Infection (UTI)
- Pregnancy or breastfeeding;
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 |
|---|---|---|
| Tamsulosin Hydrochloride 0.4 mgAlso: Cap. Urimax 0.4 mgplacement of ureteral stents followed by Cap. Tamsulosin 0.4 mg once daily | Drug | Tamsulosin group |
| Solifenacin Succinate 5 mgAlso: Tab. Solay 5 mgplacement of ureteral stents followed by Tab. Solifenacin 5 mg once daily | Drug | Solifenacin group |
| Mirabegron 25 mgAlso: Tab. Mirasin 25 mgplacement of ureteral stents followed by Tab. Mirabegron 25 mg once daily | Drug | Mirabegron group |
Primary outcome
alleviating Ureteral stent related symptoms
Time frame: 2 weeks
mitigating the ureteric stent related symptoms using structured questionnaire
1 secondary outcome
early removal of ureteral stent
Time frame: before 2 weeks
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 8 Sep 2025.
- Individual participant dataSharing planned: No
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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.
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 Tamsulosin Hydrochloride 0.4 mg, Solifenacin Succinate 5 mg and Mirabegron 25 mg in people with Ureteral Stent-Related Symptom, run by Bir Hospital at 1 site in Nepal.
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 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: looking for participants now, as of the sponsor's last update on 8 Sep 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 Nepal. 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.
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?
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?
Contact Baikuntha Adhikari, MCh (+977 9849896780, baikadhe@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
alleviating Ureteral stent related symptoms (time frame: 2 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 8 Sep 2025.