Efficacy of Mirabegron Versus Tamsulosin Versus Solifenacin for Treatment of Ureteral Stents-Related Symptoms

November 20, 2021 updated by: Amr Abdel-Lateif El-Sawy, Mansoura University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Egypt
    • DK
      • Mansoura, DK, Egypt, 35516

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients (aged 19-80 years)
  • Undergo unilateral uncomplicated retrograde rigid ureteroscopy (URS) or retrograde intrarenal surgery (RIRS) with planned ureteral stent insertion.

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo arm
Patients in this arm will receive a placebo formula
Drug: Placebo oral tablet
Patients in this arm will receive placebo oral tablet once daily
Active Comparator: Mirabegron arm
Patients in this arm will receive Mirabegrone 50 mg once daily
Drug: Mirabegron 50 MG
Patients in this arm will receive Mirabegrone 50 MG once daily
Active Comparator: Tamsulosin arm
Patients in this arm will receive tamsulosin o.4 mg once daily
Drug: Tamsulosin
Patients in this arm will receive Tamsulosin o.4 MG once daily
Active Comparator: Solifenacin arm
Patients in this arm will receive solifenacin 10 mg once daily
Drug: Solifenacin Succinate 10 MG
Patients in this arm will receive Solifenacin Succinate 10 MG once daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse event of medications
Time Frame: 4 weeks
Side effects of the assigned treatment will be monitored
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AE 24320

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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