Ureteral Stent-Related SymptomsNCT07018934
Alfuzosin and Mirabegron for Double-J Stent Symptoms
An observational study of Ureteral Stent-Related Symptoms, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial summary
This prospective randomized controlled trial investigates the effects of alfuzosin, mirabegron, and their combination on stent-related symptoms and outcomes in patients undergoing DJ stent placement after retrograde intrarenal surgery (RIRS) for renal stones. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ureteral Stent-Related Symptoms
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 1 May 2025
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients aged 18 to 75 years undergoing retrograde intrarenal surgery (RIRS) for renal stones, followed by double-J (DJ) stent placement
Who may be able to join
- Undergoing RIRS and DJ stenting
- Ability to provide informed consent
Who cannot join
- Neurogenic bladder
- Prostate volume >40 mL or significant LUTS at baseline
- Contraindications to alpha-blockers or mirabegron
- Hepatic or severe renal impairment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep University Faculty of Medicine Hospital
Gaziantep
About this study
Official title: Comparison of the Efficacy of Alpha-Blockers and Mirabegron on Symptoms Associated With Double-J Stent Implanted After Retrograde Intrarenal Surgery
This prospective randomized controlled trial investigates the effects of alfuzosin, mirabegron, and their combination on stent-related symptoms and outcomes in patients undergoing DJ stent placement after retrograde intrarenal surgery (RIRS) for renal stones. The primary outcomes include stone-free rate and residual fragment status, while secondary outcomes focus on stent-related pain and lower urinary tract symptoms (LUTS). Patients will be randomly assigned to one of four groups: alfuzosin only, mirabegron only, combination therapy, or control. Pain and LUTS will be assessed using validated questionnaires such as the Ureteral Stent Symptom Questionnaire (USSQ) and IPSS.
Read the detailed description
Retrograde intrarenal surgery (RIRS) is a commonly used minimally invasive procedure for the treatment of renal stones. Postoperative placement of double-J (DJ) stents is often necessary but can result in significant stent-related discomfort and lower urinary tract symptoms (LUTS), which negatively impact patient quality of life. Alfuzosin, an alpha-blocker, and mirabegron, a beta-3 agonist, are pharmacological agents known to reduce stent-related symptoms. This study aims to compare the individual and combined efficacy of these agents on stent-related pain, LUTS, and postoperative stone outcomes. Patients will be evaluated for stone clearance, residual fragments (by imaging), and symptom scores over a follow-up period of 2 to 4 weeks post-RIRS
- Conditions
- Ureteral Stent-Related Symptoms
- Keywords
- Nephrolithiasis, Ureteral Stent-Related Symptoms, Lower Urinary Tract Symptoms, Postoperative Pain, Retrograde Intrarenal Surgery
- Medical subject headings
- Nephrolithiasis, Lower Urinary Tract Symptoms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Group 1 : The group that did not receive medical treatment | |
| 2 | Group 2 : Alfuzosin 10 mg/d oral | |
| 3 | Group 3 : Mirabegron 50 mg/d oral | |
| 4 | Group 4 : Combination therapy with alfuzosin + Mirabegron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent-Related Pain Score
Pain score ranges from 0 to 39 (higher scores indicate worse pain).
Measured: Day 7 postoperatively and Day 14 postoperatively.
Lower Urinary Tract Symptom (LUTS) Score
IPSS ranges from 0 to 35 (higher scores indicate more severe LUTS).
Measured: Day 7 postoperatively and Day 14 postoperatively
Secondary outcomes (2)
Stone-Free Rate
Proportion of patients with no residual fragments > 2 mm on NCCT
Measured: Day 14 postoperatively
Residual Fragment Status
Categorization of residual fragments into 0 mm, 1-2 mm, or > 2 mm
Measured: Day 14 postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start1 Jun 2024
- Primary completion1 Apr 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ureteral Stent-Related 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Öztürk, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018934
- Sponsor's protocol ID
- 2024/05
- Status last verified
- Jun 2025
- First submitted
- 26 May 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) will not be shared due to patient privacy concerns and institutional policy restrictions. However, summary results will be published in scientific journals and presented at academic meetings.
Publications
Zhang K, Yan W, Li H, Chen J, Wang Q, Chai Y, Yuan L, Zhu G. Comparison of Mirabegron plus Tamsulosin and Tamsulosin Monotherapy for the Treatment of Ureteral Stent-Related Symptoms: A Prospective Randomized Study. Urol Int. 2022;106(12):1226-1232. doi: 10.1159/000526607. Epub 2022 Oct 14.
PubMed 36244331Uslu M, Yildirim U, Ezer M, Erihan IB, Sarica K. Residual fragment size following retrograde intrarenal surgery: a critical evaluation of related variables. Urolithiasis. 2023 Aug 9;51(1):100. doi: 10.1007/s00240-023-01478-8.
PubMed 37556003Geraghty RM, Davis NF, Tzelves L, Lombardo R, Yuan C, Thomas K, Petrik A, Neisius A, Turk C, Gambaro G, Skolarikos A, Somani BK. Best Practice in Interventional Management of Urolithiasis: An Update from the European Association of Urology Guidelines Panel for Urolithiasis 2022. Eur Urol Focus. 2023 Jan;9(1):199-208. doi: 10.1016/j.euf.2022.06.014. Epub 2022 Aug 1.
PubMed 35927160Yuk HD, Park J, Cho SY, Sung LH, Jeong CW. The effect of preoperative ureteral stenting in retrograde Intrarenal surgery: a multicenter, propensity score-matched study. BMC Urol. 2020 Sep 14;20(1):147. doi: 10.1186/s12894-020-00715-1.
PubMed 32928162
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Alpha-Blockers and Mirabegron on Symptoms Associated With Double-J Stent Implanted After Retrograde Intrarenal Surgery
- ClinicalTrials.gov ID
- NCT07018934
- Acronym / sponsor ID
- 2024/05
- Conditions
- Ureteral Stent-Related Symptoms
- Keywords
- Nephrolithiasis, Ureteral Stent-Related Symptoms, Lower Urinary Tract Symptoms, Postoperative Pain, Retrograde Intrarenal Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 13 Jun 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.
This prospective randomized controlled trial investigates the effects of alfuzosin, mirabegron, and their combination on stent-related symptoms and outcomes in patients undergoing DJ stent placement after retrograde intrarenal surgery (RIRS) for renal stones. The primary outcomes include stone-free rate and residual fragment status, while secondary outcomes focus on stent-related pain and lower urinary tract symptoms (LUTS). Patients will be randomly assigned to one of four groups: alfuzosin only, mirabegron only, combination therapy, or control. Pain and LUTS will be assessed using validated questionnaires such as the Ureteral Stent Symptom Questionnaire (USSQ) and IPSS.
Detailed description
Retrograde intrarenal surgery (RIRS) is a commonly used minimally invasive procedure for the treatment of renal stones. Postoperative placement of double-J (DJ) stents is often necessary but can result in significant stent-related discomfort and lower urinary tract symptoms (LUTS), which negatively impact patient quality of life. Alfuzosin, an alpha-blocker, and mirabegron, a beta-3 agonist, are pharmacological agents known to reduce stent-related symptoms. This study aims to compare the individual and combined efficacy of these agents on stent-related pain, LUTS, and postoperative stone outcomes. Patients will be evaluated for stone clearance, residual fragments (by imaging), and symptom scores over a follow-up period of 2 to 4 weeks post-RIRS
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Group 1 : The group that did not receive medical treatment |
| 2 | – | –Group 2 : Alfuzosin 10 mg/d oral |
| 3 | – | –Group 3 : Mirabegron 50 mg/d oral |
| 4 | – | –Group 4 : Combination therapy with alfuzosin + Mirabegron |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 18 to 75 years undergoing retrograde intrarenal surgery (RIRS) for renal stones, followed by double-J (DJ) stent placement
Key inclusion criteria (2 listed)
- Undergoing RIRS and DJ stenting
- Ability to provide informed consent
Key exclusion criteria (4 listed)
- Neurogenic bladder
- Prostate volume >40 mL or significant LUTS at baseline
- Contraindications to alpha-blockers or mirabegron
- Hepatic or severe renal impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stent-Related Pain Score
Time frame: Day 7 postoperatively and Day 14 postoperatively.
Pain score ranges from 0 to 39 (higher scores indicate worse pain).
Lower Urinary Tract Symptom (LUTS) Score
Time frame: Day 7 postoperatively and Day 14 postoperatively
IPSS ranges from 0 to 35 (higher scores indicate more severe LUTS).
2 secondary outcomes
Stone-Free Rate
Time frame: Day 14 postoperatively
Residual Fragment Status
Time frame: Day 14 postoperatively
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 13 Jun 2025.
- Results publication: PubMed 36244331Zhang K, Yan W, Li H, Chen J, Wang Q, Chai Y, Yuan L, Zhu G. Comparison of Mirabegron plus Tamsulosin and Tamsulosin Monotherapy for the Treatment of Ureteral Stent-Related Symptoms: A Prospective Randomized Study. Urol Int. 2022;106(12):1226-1232. doi: 10.1159/000526607. Epub 2022 Oct 14.
- Results publication: PubMed 37556003Uslu M, Yildirim U, Ezer M, Erihan IB, Sarica K. Residual fragment size following retrograde intrarenal surgery: a critical evaluation of related variables. Urolithiasis. 2023 Aug 9;51(1):100. doi: 10.1007/s00240-023-01478-8.
- Results publication: PubMed 35927160Geraghty RM, Davis NF, Tzelves L, Lombardo R, Yuan C, Thomas K, Petrik A, Neisius A, Turk C, Gambaro G, Skolarikos A, Somani BK. Best Practice in Interventional Management of Urolithiasis: An Update from the European Association of Urology Guidelines Panel for Urolithiasis 2022. Eur Urol Focus. 2023 Jan;9(1):199-208. doi: 10.1016/j.euf.2022.06.014. Epub 2022 Aug 1.
- Results publication: PubMed 32928162Yuk HD, Park J, Cho SY, Sung LH, Jeong CW. The effect of preoperative ureteral stenting in retrograde Intrarenal surgery: a multicenter, propensity score-matched study. BMC Urol. 2020 Sep 14;20(1):147. doi: 10.1186/s12894-020-00715-1.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) will not be shared due to patient privacy concerns and institutional policy restrictions. However, summary results will be published in scientific journals and presented at academic meetings.
Related trials for Ureteral Stent-Related Symptoms
RecruitingPhase 1/2
Dexamethasone for Ureteral STent Symptoms (DUSTS)
Ureteral Stent-Related Symptom
Enrolling by invitation
Impact of Ureteral Stent and Sheaths Size on Post-Operative Pain
Ureteral Stent-Related Symptom, Retrograde Intra-renal Surgery
Not yet recruitingPhase 3
Assessing Suzetrigine for Pain Reduction Following Ureteroscopic Surgery
Opioid Consumption, Postoperative, Multimodal Analgesia
Active, not recruiting
Optimal Stent Duration After Ureteroscopy
Ureteral Stent
RecruitingObservational study
Clinical Evaluation of the Pelvic Floor Fatigue Index (PFFI)
Urolithiasis
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?
An observational study of Ureteral Stent-Related Symptoms, run by University of Gaziantep at 1 site in Turkey (Türkiye).
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 4 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 13 Jun 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 Turkey (Türkiye). 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?
Stent-Related Pain Score (time frame: Day 7 postoperatively and Day 14 postoperatively.). 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?
On the ClinicalTrials.gov record for NCT07018934, which also lists 4 linked publications.
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 13 Jun 2025.