Ureteral StonePhase 4NCT06124066
THE EFFECTS OF MIRABEGRON AND TAMSULOSIN FOR PATIENTS WITH URETERAL STENTS
A Phase 4 study testing Mirabegron 50 MG in people with Ureteral Stone and Kidney Stones, run by Hasanuddin University at 1 site in Indonesia.
Trial summary
Double J stent (ureteral stent) can cause discomfort to patients, generally due to irritation of the bladder mucosa, especially in the trigone area, smooth muscle spasm, and reflux of urine into the ureter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ureteral Stone, Kidney Stones, Ureteral Stenosis
- What is being tested?
- Mirabegron 50 MG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jul 2022to 30 Oct 2022
- Phase
- Phase 4
- 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 > 18 years
- Patient with first ureterorenoscopy and ureteral stent placement
- Using a semi-rigid (rigid) retrograde or flexible (flexible) ureteroscope
- Stent placement on one side
- Stent installation size 4.7 Fr, length 24-26cm hydrophilic coated ureteric stent
- Patients who can read and understand Indonesia language (Bahasa Indonesia)
Who cannot join
- Patients with or who have a history of malignancy of the urinary tract
- Patients with LUTS caused by benign prostatic enlargement, bladder stones, or urethral strictures
- Catheterized patients or on self-catheter therapy regularly and patients with urinary diversion
- Patients with Post void residual volume > 350 mL
- Patients with neurogenic bladder and/or OAB syndrome, stress incontinence, or mixed stress/urge incontinence
- Patients with chronic pain that is not controlled or on therapy to manage chronic pain
Show all 13Show fewer
- Patients with symptomatic UTI
- Patients with a prior history of sexual dysfunction
- Have or are currently undergoing radiation therapy/hormonal therapy and/or surgical procedures in the minor pelvis, ureteral reconstructive surgery.
- Patients with primary neurological disorders, such as multiple sclerosis, Parkinson's disease, diabetic nephropathy, or other neurological diseases that affect bladder function.
- Patients who are hypersensitive to mirabegron and tamsulosin or their derivatives and patients with mirabegron and tamsulosin contraindications.
- The patient could not follow the research protocol due to an organic brain disorder or psychiatric disorder
- Patients with autoimmune diseases and other inflammatory diseases, as well as patients taking immunosuppressant drugs
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
DR Wahidin Sudirohusodo Hospital, Hasanuddin University Hospital, and Akademis Jaury Jusuf Putra Hospital.
Makassar, South Sulawesi, 90245
About this study
Double J stent (ureteral stent) can cause discomfort to patients, generally due to irritation of the bladder mucosa, especially in the trigone area, smooth muscle spasm, and reflux of urine into the ureter. Complaints often appear in patients, especially lower urinary tract symptoms (LUTS), pain in the waist when urinating due to reflux of urine, sexual dysfunction, and hematuria.
Currently, to assess complaints after ureteral stent placement, the Ureteral Stent Symptom Questionnaire instrument consists of 6 topics: urinary complaints, pain, general health, work, sexual problems, and other things.
Read more
Interleukin-6 is an important inflammatory cytokine when irritation occurs after ureteral stent placement. Interleukin 10 is a cytokine with potent anti-inflammatory properties that plays a central role in limiting the host's immune response to pathogens, thereby preventing host damage and maintaining normal tissue homeostasis. The profile of these biomarkers has the potential to determine the correct prognosis and therapy.
Mirabegron is a β3 adrenergic receptor agonist that has a dual antioxidant effect that plays a key role in the first step of the antimicrobial response and early resolution of inflammation so that post-stent complaints similar to overactive bladder complaints can be resolved. Tamsulosin (a selective α1A- and α1D-adrenoceptor antagonist) has a relaxing effect on the smooth muscle in the prostate, the neck of the bladder, and the distal ureter, thereby reducing the inflammatory reaction and improving oxidative stress by reducing the formation of reactive oxidative stress.
Read the detailed description
The research design used was experimental with randomized sampling, double-blinded, in men and women with ureteral stents. The patient signed informed consent regarding blood and urine sampling, bladder mucosal biopsy, placement and removal of ureteral stents, drug administration, and side effects of therapy. The history and physical examination of the patient were recorded including age, height, weight, and body mass index (BMI). Investigation procedures for urinalysis, routine blood, SGOT/SGPT, urea/creatinine, blood sugar during, ultrasonography, plain abdominal photos, and CT scan urography were performed on patients before surgery. The patient's largest stone size is used as a benchmark to record the patient's stone size.
All patients who underwent routine post-ureterorenoscopy lithotripsy (URSL) ureteral stent procedures and met the inclusion and exclusion criteria were included in the study evaluation. The ureteral stent used was 4.7 Fr in size with a length of 24-26 cm, made from polyurethane used in all patients.
Blood and urine samples will be taken before drug administration begins, and when the ureteral stent is removed or replaced. Bladder mucosal biopsy was performed in the trigone vesicae around the contralateral ureteral opening during cystoscopy before ureteral stent placement, and on the ipsilateral side when the ureteral stent was to be removed or replaced in the 6th week after ureteral stent placement.
A plain photo of the abdomen or ultrasound is done postoperatively to see the remaining stone fragments and the position of the ureteral stent. Urethral catheters were removed on the 2nd postoperative day in all patients before the patients were discharged and given oral antibiotics (cefadroxil) for 5 days. During the observation phase, the patient was given the same analgesic (paracetamol 500 mg every 8 hours/24 hours and if needed can be given every 6 hours/24 hours). The total amount of analgesics consumed by the patient will be recorded in filling out the final questionnaire.
Patients were asked to come to the urology clinic at the hospital for control on the seventh day. The patient will be given a questionnaire format that will measure the presence or absence and severity of side effects experienced by the patient for 7 days after ureteral stent placement.
Patients will be divided into 3 groups of drug administration. The double-blinded method is used to minimize bias. All medicines were placed in the same 3 boxes, which were held by the paramedics so that the patients and researchers did not know the allocation of the types of drugs given. All patients have been informed about the side effects of the drug.
Administration of mirabegron 50 mg/day compared to tamsulosin 0.4 mg and placebo began on the third day before insertion of the ureteral stent. Completion of the questionnaire began on the seventh day after ureteral stent insertion, then it was measured every 7 days (7th, 14th, 21st, 28th, 35th, and 42nd day) after ureteral stent insertion. Filling out the questionnaire can be done by in-person interview at the clinic or by telephone.
- Conditions
- Ureteral Stone, Kidney Stones, Ureteral Stenosis
- Being tested
- Mirabegron 50 MG
- Keywords
- Double J stent, Mirabegron, Tamsulosin, Interleukin-6, Interleukin-10, lower urinary tract symptoms
- Medical subject headings
- Ureterolithiasis, Kidney Calculi, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirabegron 50 MGDrug
Also called Tamsulosin 0.4 mg, Placebo
The participants were given mirabegron 50 mg or tamsulosin 0.4 mg and filled in the Ureteral Stent Symptom Questionnaire (USSQ), filled in directly when the patient arrived or by telephone.
| Study group | Role | What they receive |
|---|---|---|
| Mirabegron | Active comparator | The participants were given mirabegron 50 mirabegron/day started 3 days before DJ stent insertion and until 6 weeks after the DJ stent insertion and filled in USSQ every week until 6 weeks after the DJ stent insertion(filled in directly when the patient arrived or by telephone) Receives: Drug: Mirabegron 50 MG |
| Tamsulosin | Active comparator | The participants were given tamsulosin 0.4 mg that was started 3 days before DJ stent insertion and until 6 weeks after the DJ stent insertion and filled in USSQ every week until 6 weeks after the DJ stent insertion(filled in directly when the patient arrived or by telephone) Receives: Drug: Mirabegron 50 MG |
| Placebo | Placebo comparator | The participants were given a placebo that was started 3 days before DJ stent insertion and until 6 weeks after the DJ stent insertion and filled in USSQ every week until 6 weeks after the DJ stent insertion(filled in directly when the patient arrives or by telephone) Receives: Drug: Mirabegron 50 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum and urine Interleukin-6 serum level (ELISA)
Interleukin-6 serum level
Measured: Pre-intervention and immediately after the intervention
serum and urine Interleukin-10 serum level (ELISA)
Interleukin-10 serum level
Measured: Pre-intervention and immediately after the intervention
Histopathology
The severity of the mucosal inflammatory reaction was graded using a semiquantitative scale where 0=none, 1 = focal lymphocytic infiltration, 2 =diffuse predominantly lymphocytic infiltration, 3 =diffuse predominantly eosinophil polymorphonuclear infiltration and 4 = grade 3 changes in combination with intra-epithelial eosinophilic micro-abscesses.
Measured: Pre-intervention and immediately after the intervention
Urinary symptoms in the Ureteral Stent Symptom Questionnaire (USSQ) parameter
Minimum values 2 and maximum values 47
Measured: Pre-intervention, immediately after the interventio, and up to 4 weeks
Secondary outcomes (1)
Basis data
Characteristic data participants
Measured: pre-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start1 Jul 2022
- Primary completion30 Sep 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral StoneStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be divided into 3 groups of drug administration: Group A, Group B, and Group C.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Asykar Palinrungi, Hasanuddin University
- Investigators
- Muhammad A Palinrungi, Study director, Hasanuddin University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124066
- Sponsor's protocol ID
- 583/UN4.6.4.5.37/PP36/2022
- Status last verified
- Nov 2023
- First submitted
- 2 Sep 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data supporting this study's findings are available on request from the corresponding author (Muhammad Asykar Palinrung).
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECTS OF MIRABEGRON AND TAMSULOSIN FOR PATIENTS WITH URETERAL STENTS
- ClinicalTrials.gov ID
- NCT06124066
- Acronym / sponsor ID
- 583/UN4.6.4.5.37/PP36/2022
- Conditions
- Ureteral Stone, Kidney Stones, Ureteral Stenosis
- Keywords
- Double J stent, Mirabegron, Tamsulosin, Interleukin-6, Interleukin-10, lower urinary tract symptoms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 9 Nov 2023 (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.
Double J stent (ureteral stent) can cause discomfort to patients, generally due to irritation of the bladder mucosa, especially in the trigone area, smooth muscle spasm, and reflux of urine into the ureter. Complaints often appear in patients, especially lower urinary tract symptoms (LUTS), pain in the waist when urinating due to reflux of urine, sexual dysfunction, and hematuria.
Currently, to assess complaints after ureteral stent placement, the Ureteral Stent Symptom Questionnaire instrument consists of 6 topics: urinary complaints, pain, general health, work, sexual problems, and other things.
Interleukin-6 is an important inflammatory cytokine when irritation occurs after ureteral stent placement. Interleukin 10 is a cytokine with potent anti-inflammatory properties that plays a central role in limiting the host's immune response to pathogens, thereby preventing host damage and maintaining normal tissue homeostasis. The profile of these biomarkers has the potential to determine the correct prognosis and therapy.
Mirabegron is a β3 adrenergic receptor agonist that has a dual antioxidant effect that plays a key role in the first step of the antimicrobial response and early resolution of inflammation so that post-stent complaints similar to overactive bladder complaints can be resolved. Tamsulosin (a selective α1A- and α1D-adrenoceptor antagonist) has a relaxing effect on the smooth muscle in the prostate, the neck of the bladder, and the distal ureter, thereby reducing the inflammatory reaction and improving oxidative stress by reducing the formation of reactive oxidative stress.
Detailed description
The research design used was experimental with randomized sampling, double-blinded, in men and women with ureteral stents. The patient signed informed consent regarding blood and urine sampling, bladder mucosal biopsy, placement and removal of ureteral stents, drug administration, and side effects of therapy. The history and physical examination of the patient were recorded including age, height, weight, and body mass index (BMI). Investigation procedures for urinalysis, routine blood, SGOT/SGPT, urea/creatinine, blood sugar during, ultrasonography, plain abdominal photos, and CT scan urography were performed on patients before surgery. The patient's largest stone size is used as a benchmark to record the patient's stone size.
All patients who underwent routine post-ureterorenoscopy lithotripsy (URSL) ureteral stent procedures and met the inclusion and exclusion criteria were included in the study evaluation. The ureteral stent used was 4.7 Fr in size with a length of 24-26 cm, made from polyurethane used in all patients.
Blood and urine samples will be taken before drug administration begins, and when the ureteral stent is removed or replaced. Bladder mucosal biopsy was performed in the trigone vesicae around the contralateral ureteral opening during cystoscopy before ureteral stent placement, and on the ipsilateral side when the ureteral stent was to be removed or replaced in the 6th week after ureteral stent placement.
A plain photo of the abdomen or ultrasound is done postoperatively to see the remaining stone fragments and the position of the ureteral stent. Urethral catheters were removed on the 2nd postoperative day in all patients before the patients were discharged and given oral antibiotics (cefadroxil) for 5 days. During the observation phase, the patient was given the same analgesic (paracetamol 500 mg every 8 hours/24 hours and if needed can be given every 6 hours/24 hours). The total amount of analgesics consumed by the patient will be recorded in filling out the final questionnaire.
Patients were asked to come to the urology clinic at the hospital for control on the seventh day. The patient will be given a questionnaire format that will measure the presence or absence and severity of side effects experienced by the patient for 7 days after ureteral stent placement.
Patients will be divided into 3 groups of drug administration. The double-blinded method is used to minimize bias. All medicines were placed in the same 3 boxes, which were held by the paramedics so that the patients and researchers did not know the allocation of the types of drugs given. All patients have been informed about the side effects of the drug.
Administration of mirabegron 50 mg/day compared to tamsulosin 0.4 mg and placebo began on the third day before insertion of the ureteral stent. Completion of the questionnaire began on the seventh day after ureteral stent insertion, then it was measured every 7 days (7th, 14th, 21st, 28th, 35th, and 42nd day) after ureteral stent insertion. Filling out the questionnaire can be done by in-person interview at the clinic or by telephone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Patients will be divided into 3 groups of drug administration: Group A, Group B, and Group C.
| Arm | Type | Receives |
|---|---|---|
| Mirabegron | Active comparator | Drug: Mirabegron 50 MGThe participants were given mirabegron 50 mirabegron/day started 3 days before DJ stent insertion and until 6 weeks after the DJ stent insertion and filled in USSQ every week until 6 weeks after the DJ stent insertion(filled in directly when the patient arrived or by telephone) |
| Tamsulosin | Active comparator | Drug: Mirabegron 50 MGThe participants were given tamsulosin 0.4 mg that was started 3 days before DJ stent insertion and until 6 weeks after the DJ stent insertion and filled in USSQ every week until 6 weeks after the DJ stent insertion(filled in directly when the patient arrived or by telephone) |
| Placebo | Placebo comparator | Drug: Mirabegron 50 MGThe participants were given a placebo that was started 3 days before DJ stent insertion and until 6 weeks after the DJ stent insertion and filled in USSQ every week until 6 weeks after the DJ stent insertion(filled in directly when the patient arrives or by telephone) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18 years
- Patient with first ureterorenoscopy and ureteral stent placement
- Using a semi-rigid (rigid) retrograde or flexible (flexible) ureteroscope
- Stent placement on one side
- Stent installation size 4.7 Fr, length 24-26cm hydrophilic coated ureteric stent
Key exclusion criteria (13 listed)
- Patients with or who have a history of malignancy of the urinary tract
- Patients with LUTS caused by benign prostatic enlargement, bladder stones, or urethral strictures
- Catheterized patients or on self-catheter therapy regularly and patients with urinary diversion
- Patients with Post void residual volume > 350 mL
- Patients with neurogenic bladder and/or OAB syndrome, stress incontinence, or mixed stress/urge incontinence
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 |
|---|---|---|
| Mirabegron 50 MGAlso: Tamsulosin 0.4 mg, PlaceboThe participants were given mirabegron 50 mg or tamsulosin 0.4 mg and filled in the Ureteral Stent Symptom Questionnaire (USSQ), filled in directly when the patient arrived or by telephone. | Drug | Mirabegron, Placebo, Tamsulosin |
Primary outcome
serum and urine Interleukin-6 serum level (ELISA)
Time frame: Pre-intervention and immediately after the intervention
Interleukin-6 serum level
serum and urine Interleukin-10 serum level (ELISA)
Time frame: Pre-intervention and immediately after the intervention
Interleukin-10 serum level
Histopathology
Time frame: Pre-intervention and immediately after the intervention
The severity of the mucosal inflammatory reaction was graded using a semiquantitative scale where 0=none, 1 = focal lymphocytic infiltration, 2 =diffuse predominantly lymphocytic infiltration, 3 =diffuse predominantly eosinophil polymorphonuclear infiltration and 4 = grade 3 changes in combination with intra-epithelial eosinophilic micro-abscesses.
Urinary symptoms in the Ureteral Stent Symptom Questionnaire (USSQ) parameter
Time frame: Pre-intervention, immediately after the interventio, and up to 4 weeks
Minimum values 2 and maximum values 47
1 secondary outcome
Basis data
Time frame: pre-intervention
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 Nov 2023.
- Individual participant dataSharing planned: No. The data supporting this study's findings are available on request from the corresponding author (Muhammad Asykar Palinrung).
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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.
Muhammad A Palinrungi study director
Hasanuddin University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mirabegron 50 MG in people with Ureteral Stone and Kidney Stones, run by Hasanuddin University at 1 site in Indonesia.
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 6 inclusion and 13 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 Nov 2023. 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 Indonesia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
serum and urine Interleukin-6 serum level (ELISA) (time frame: Pre-intervention and immediately after the intervention). The study lists 4 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 13 Nov 2023.