Efficacy of Mirabegron Versus Tamsulosin Versus Solifenacin for Treatment of Ureteral Stents-Related Symptoms
NCT ID: NCT04325880
Last Updated: 2021-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
240 participants
INTERVENTIONAL
2021-12-01
2022-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
In addition, adverse events of the utilized medications will be monitored during study period as a secondary objective.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo arm
Patients in this arm will receive a placebo formula
Placebo oral tablet
Patients in this arm will receive placebo oral tablet once daily
Mirabegron arm
Patients in this arm will receive Mirabegrone 50 mg once daily
Mirabegron 50 MG
Patients in this arm will receive Mirabegrone 50 MG once daily
Tamsulosin arm
Patients in this arm will receive tamsulosin o.4 mg once daily
Tamsulosin
Patients in this arm will receive Tamsulosin o.4 MG once daily
Solifenacin arm
Patients in this arm will receive solifenacin 10 mg once daily
Solifenacin Succinate 10 MG
Patients in this arm will receive Solifenacin Succinate 10 MG once daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mirabegron 50 MG
Patients in this arm will receive Mirabegrone 50 MG once daily
Tamsulosin
Patients in this arm will receive Tamsulosin o.4 MG once daily
Solifenacin Succinate 10 MG
Patients in this arm will receive Solifenacin Succinate 10 MG once daily
Placebo oral tablet
Patients in this arm will receive placebo oral tablet once daily
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Undergo unilateral uncomplicated retrograde rigid ureteroscopy (URS) or retrograde intrarenal surgery (RIRS) with planned ureteral stent insertion.
Exclusion Criteria
* Residual ureteral or renal stones after the procedure
* Preoperative febrile UTI
* pregnancy or breastfeeding
* Bilateral ureteroscopic surgery
* Single kidney
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mansoura University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Amr Abdel-Lateif El-Sawy
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Amr A Elsawy
Role: PRINCIPAL_INVESTIGATOR
Mansoura University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Urology and Nephrology Center
Al Mansurah, DK, Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Amr A Elsawy
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AE 24320
Identifier Type: -
Identifier Source: org_study_id