Ureteral StentPhase 3NCT04325880
Efficacy of Mirabegron Versus Tamsulosin Versus Solifenacin for Treatment of Ureteral Stents-Related Symptoms
A Phase 3 study testing Mirabegron 50 MG, Tamsulosin and Solifenacin Succinate 10 MG in people with Ureteral Stent and Stent Related Symptoms, run by Mansoura University at 1 site in Egypt.
Trial summary
The primary objective of this prospective, single-centre randomized controlled trial is to assess the efficacy of three different drugs in treatment of ureteral stents related symptoms (Beta 3 adrenergic receptor agonist; Mirabegron 50mg) vs. (Alpha 1 adrenergic receptor antagonist; Tamsulosin 0.4mg) vs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ureteral Stent, Stent Related Symptoms
- What is being tested?
- Mirabegron 50 MG, Tamsulosin and Solifenacin Succinate 10 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to 1 Jul 2022
- Phase
- Phase 3
- 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
- Adult patients (aged 19-80 years)
- Undergo unilateral uncomplicated retrograde rigid ureteroscopy (URS) or retrograde intrarenal surgery (RIRS) with planned ureteral stent insertion.
Who cannot join
- Patients with neurogenic bladder, OAB syndrome, and neurological and psychiatric diseases
- Residual ureteral or renal stones after the procedure
- Preoperative febrile UTI
- pregnancy or breastfeeding
- Bilateral ureteroscopic surgery
- Single kidney
Show all 13Show fewer
- Chronic kidney disease
- Cardiovascular or cerebrovascular disease
- Hepatic dysfunction
- History of pelvic surgery or irradiation
- History of bladder or prostate surgery
- Other acute medical conditions as acute gastroenteritis, osetoarthritis that might influence the patient QoL
- Preoperative indwelling of ureteral stent for relief of stone-related pain or sepsis
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Urology and Nephrology Center
Al Mansurah, DK, 35516
Amr A Elsawy, 0502202222, amrelsawy.unc@hotmail.com
About this study
Official title: Efficacy of Mirabegron Versus Tamsulosin Versus Solifenacin for Treatment of Ureteral Stents-Related Symptoms: a Randomized Controlled Trial
The primary objective of this prospective, single-centre randomized controlled trial is to assess the efficacy of three different drugs in treatment of ureteral stents related symptoms (Beta 3 adrenergic receptor agonist; Mirabegron 50mg) vs. (Alpha 1 adrenergic receptor antagonist; Tamsulosin 0.4mg) vs. (Anticholinergic; Solifenacin 10 mg) using validated symptoms questionnaires.
In addition, adverse events of the utilized medications will be monitored during study period as a secondary objective.
Read the detailed description
Indwelling ureteral stents are specialized catheters designed to alleviate obstruction by maintaining the patency of the ureteral lumen and to splint the ureter by acting as a scaffold to promote organized tissue healing. (1)
Common issues associated with contemporary ureteral stents include stent-related pain, hematuria, dysuria, urgency, infection, and encrustation (2). Majority of patients (80%) reported one or more urinary symptoms with over 80% of patients experience stent-related pain that affects daily activities, 58% report reduced work capacity, and 32%report sexual dysfunction (2). In addition, as many as 32% of patients had ureteral stents removed sooner than anticipated because of these complications (3).
Considering this high prevalence of ureteral stent related symptoms (uSRS) among patients and its potential impact on quality of life (QoL), adequate management of these bothering symptoms was the point of research over the last decades (4).
The exact mechanism involved in uSRS is not yet known; however, many authors report that such symptoms are associated with ureteral spasms, urinary reflux attributable to ureteral stent, or trigonal irritation (5).
Different novel types of stents have been developed and evaluated to reduce uSRS; however, there is still controversy regarding their clinical application (6). Conversely, pharmacological therapy, including anticholinergics and alpha-blockers, remains the most effective option to manage uSRS (7).
The role of a-blockers in reducing uSRS involves reduction of bladder outlet resistance to alleviate flank pain in male patients with preexisting bladder outlet obstruction (BOO). It has been proposed that relaxing the distal ureter and irritation of the trigone decreases bladder outlet resistance and voiding pressure, thereby potentially decreasing the incidence of renal reflux and subsequent flank pain (8) . Otherwise, anticholinergic agents may have an effect on involuntary contractions of the bladder induced by the distal end of ureteral stents with subsequent relief of uSRS (9).
The above-mentioned drugs, however, are not easy to apply to some patients with co-morbidities because of the potential side effects. The most common medication-related complications of a-blockers are dizziness and orthostatic hypotension. Depending on the type of medication, medication-related adverse events are reported at a rate of 5% to 20% (10). In addition, anticholinergic agents have various adverse effects that decrease treatment compliance, such as dry mouth, constipation, blurred vision and dyspepsia (11).
Beta-3 agonist mirabegron is believed to be responsible for the relaxation of the detrusor smooth muscle during the storage phase (12). It helps relax the detrusor smooth muscle, and results in increased bladder capacity without any changes in micturition pressure, post-void residual urine volume, or voiding contractions.
Considering the function of mirabegron as a therapeutic agent for overactive bladder (OAB), mirabegron is assumed to be effective for relieving voiding symptoms attributable to uSRS (13).
- Conditions
- Ureteral Stent, Stent Related Symptoms
- Being tested
- Mirabegron 50 MG, Tamsulosin, Solifenacin Succinate 10 MG, Placebo oral tablet
- Keywords
- Ureteral stone, Ureteral stent, Stent related symptoms, Quality of life
- Medical subject headings
- Ureterolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirabegron 50 MGDrug
Patients in this arm will receive Mirabegrone 50 MG once daily
TamsulosinDrug
Patients in this arm will receive Tamsulosin o.4 MG once daily
Solifenacin Succinate 10 MGDrug
Patients in this arm will receive Solifenacin Succinate 10 MG once daily
Placebo oral tabletDrug
Patients in this arm will receive placebo oral tablet once daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo arm | Placebo comparator | Patients in this arm will receive a placebo formula Receives: Drug: Placebo oral tablet |
| Mirabegron arm | Active comparator | Patients in this arm will receive Mirabegrone 50 mg once daily Receives: Drug: Mirabegron 50 MG |
| Tamsulosin arm | Active comparator | Patients in this arm will receive tamsulosin o.4 mg once daily Receives: Drug: Tamsulosin |
| Solifenacin arm | Active comparator | Patients in this arm will receive solifenacin 10 mg once daily Receives: Drug: Solifenacin Succinate 10 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in stent related symptoms using ureteral stent symptoms questionnaire (USSQ)
The effect of the assigned treatment on improvement of stent related symptoms will be assessed at the time of stent removal using ureteral stent symptoms questionnaire (USSQ)
Measured: 4 weeks
Secondary outcomes (1)
Adverse event of medications
Side effects of the assigned treatment will be monitored
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 posted30 Mar 2020
- Study start1 Dec 2021 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral StentStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Abdel-Lateif El-Sawy, Mansoura University
- Investigators
- Amr A Elsawy, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325880
- Sponsor's protocol ID
- AE 24320
- Status last verified
- Nov 2021
- First submitted
- 24 Mar 2020
- Last updated
- 23 Nov 2021
- Results posted
- No
- 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 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Mirabegron Versus Tamsulosin Versus Solifenacin for Treatment of Ureteral Stents-Related Symptoms: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04325880
- Acronym / sponsor ID
- AE 24320
- Conditions
- Ureteral Stent, Stent Related Symptoms
- Keywords
- Ureteral stone, Ureteral stent, Stent related symptoms, Quality of life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 30 Mar 2020 (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.
The primary objective of this prospective, single-centre randomized controlled trial is to assess the efficacy of three different drugs in treatment of ureteral stents related symptoms (Beta 3 adrenergic receptor agonist; Mirabegron 50mg) vs. (Alpha 1 adrenergic receptor antagonist; Tamsulosin 0.4mg) vs. (Anticholinergic; Solifenacin 10 mg) using validated symptoms questionnaires.
In addition, adverse events of the utilized medications will be monitored during study period as a secondary objective.
Detailed description
Indwelling ureteral stents are specialized catheters designed to alleviate obstruction by maintaining the patency of the ureteral lumen and to splint the ureter by acting as a scaffold to promote organized tissue healing. (1)
Common issues associated with contemporary ureteral stents include stent-related pain, hematuria, dysuria, urgency, infection, and encrustation (2). Majority of patients (80%) reported one or more urinary symptoms with over 80% of patients experience stent-related pain that affects daily activities, 58% report reduced work capacity, and 32%report sexual dysfunction (2). In addition, as many as 32% of patients had ureteral stents removed sooner than anticipated because of these complications (3).
Considering this high prevalence of ureteral stent related symptoms (uSRS) among patients and its potential impact on quality of life (QoL), adequate management of these bothering symptoms was the point of research over the last decades (4).
The exact mechanism involved in uSRS is not yet known; however, many authors report that such symptoms are associated with ureteral spasms, urinary reflux attributable to ureteral stent, or trigonal irritation (5).
Different novel types of stents have been developed and evaluated to reduce uSRS; however, there is still controversy regarding their clinical application (6). Conversely, pharmacological therapy, including anticholinergics and alpha-blockers, remains the most effective option to manage uSRS (7).
The role of a-blockers in reducing uSRS involves reduction of bladder outlet resistance to alleviate flank pain in male patients with preexisting bladder outlet obstruction (BOO). It has been proposed that relaxing the distal ureter and irritation of the trigone decreases bladder outlet resistance and voiding pressure, thereby potentially decreasing the incidence of renal reflux and subsequent flank pain (8) . Otherwise, anticholinergic agents may have an effect on involuntary contractions of the bladder induced by the distal end of ureteral stents with subsequent relief of uSRS (9).
The above-mentioned drugs, however, are not easy to apply to some patients with co-morbidities because of the potential side effects. The most common medication-related complications of a-blockers are dizziness and orthostatic hypotension. Depending on the type of medication, medication-related adverse events are reported at a rate of 5% to 20% (10). In addition, anticholinergic agents have various adverse effects that decrease treatment compliance, such as dry mouth, constipation, blurred vision and dyspepsia (11).
Beta-3 agonist mirabegron is believed to be responsible for the relaxation of the detrusor smooth muscle during the storage phase (12). It helps relax the detrusor smooth muscle, and results in increased bladder capacity without any changes in micturition pressure, post-void residual urine volume, or voiding contractions.
Considering the function of mirabegron as a therapeutic agent for overactive bladder (OAB), mirabegron is assumed to be effective for relieving voiding symptoms attributable to uSRS (13).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo arm | Placebo comparator | Drug: Placebo oral tabletPatients in this arm will receive a placebo formula |
| Mirabegron arm | Active comparator | Drug: Mirabegron 50 MGPatients in this arm will receive Mirabegrone 50 mg once daily |
| Tamsulosin arm | Active comparator | Drug: TamsulosinPatients in this arm will receive tamsulosin o.4 mg once daily |
| Solifenacin arm | Active comparator | Drug: Solifenacin Succinate 10 MGPatients in this arm will receive solifenacin 10 mg once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (aged 19-80 years)
- Undergo unilateral uncomplicated retrograde rigid ureteroscopy (URS) or retrograde intrarenal surgery (RIRS) with planned ureteral stent insertion.
Key exclusion criteria (13 listed)
- Patients with neurogenic bladder, OAB syndrome, and neurological and psychiatric diseases
- Residual ureteral or renal stones after the procedure
- Preoperative febrile UTI
- pregnancy or breastfeeding
- Bilateral ureteroscopic surgery
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 MGPatients in this arm will receive Mirabegrone 50 MG once daily | Drug | Mirabegron arm |
| TamsulosinPatients in this arm will receive Tamsulosin o.4 MG once daily | Drug | Tamsulosin arm |
| Solifenacin Succinate 10 MGPatients in this arm will receive Solifenacin Succinate 10 MG once daily | Drug | Solifenacin arm |
| Placebo oral tabletPatients in this arm will receive placebo oral tablet once daily | Drug | Placebo arm |
Primary outcome
Improvement in stent related symptoms using ureteral stent symptoms questionnaire (USSQ)
Time frame: 4 weeks
The effect of the assigned treatment on improvement of stent related symptoms will be assessed at the time of stent removal using ureteral stent symptoms questionnaire (USSQ)
1 secondary outcome
Adverse event of medications
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- Individual participant dataSharing planned: Undecided
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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.
Amr A Elsawy principal investigator
Mansoura University
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 Mirabegron 50 MG, Tamsulosin and Solifenacin Succinate 10 MG in people with Ureteral Stent and Stent Related Symptoms, run by Mansoura 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 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: status not confirmed, as of the sponsor's last update on 23 Nov 2021. 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?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amr A Elsawy (0502202222, amrelsawy.unc@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in stent related symptoms using ureteral stent symptoms questionnaire (USSQ) (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 23 Nov 2021.