Mirabegron 25 mg for Treatment of Primary Nocturnal Enuresis

August 2, 2023 updated by: Hosam Abu El-nasr, Benha University

Is Mirabegron 25 mg Safe and Effective in Treatment of Primary Nocturnal Enuresis as Regard Oral Desmopressin 120 mcg?

Investigators will study the efficacy and safety of mirabegron25 in treatment of primary nocturnal enuresis in comparison to oral desmopressin 120 mcg and behavioral therapy

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

No doubt that nocturnal enuresis is one of the commonest types of urinary incontinence which affect children and always run in family . Nocturnal enuresis occurs at the age of 5 years with leakage of urine involuntarily during sleep for two times or more per week in three consecutive months not due to congenital or acquired cause. Nocturnal enuresis can be categorized into primary or secondary depending on occurrence of bed dryness for more than six months or not .

Nocturnal enuresis affects 15% to 20 % of children at five years old mainly due to delay of bladder development and function more in male children with presence of family history in half of cases but 15% of children with enuresis recover spontaneously every year .

limitation of fluid intake, urotherapy and bedwetting alarms are non-pharmacological treatments of nocturnal enuresis while the mostly used drugs for treatment of NE are tricyclic antidepressants(Imipramine®) an arginine vasopressin analog (Desmopressin®) and anticholinergic drugs . Enuresis alarms have pitfalls which disgust a lot of patients as skin irritation, sleep disturbances of other family members and failure to wake the child so that about 30% of patients stop its usage .

Desmopressin is approved as a first-line drug therapy for nocturnal enuresis , but a lot of series declared that monotherapy with desmopressin has little efficacy in treating patients which have bladder storage dysfunction furthermore, high recurrence rate after treatment cessation .

The International Children's Continence Society (ICCS) recommended combination therapy for treatment of primary nocturnal enuresis after failure of first line therapy with desmopressin or enuresis alarms . As regard anticholinergic drugs, oxybutynin was firstly prescribed then tolterodine with less side effects and lately solifenacin . Cognitive impairment as a neurological side effect was authenticated for oxybutynin and other side effects (e.g. headache, dry mouth, behavior change, flushed cheeks, constipation, and blurred vision) were unbearable to many children and impulsed them to stop treatment early .

Mirabegron, a b3-adrenoceptor (b3-AR) agonist was the answer to the question about a drug that can relax detrusor muscle and increasing bladder capacity without the limitations of anti-cholinergic drugs. Mirabegron is the first b3-AR agonist to be prescribed clinically for OAB symptoms in adults and showed promising outcomes . while it is not licensed to be used in children with overactive bladder, some early reports declared its efficacy and tolerability in children .

So investigators will study the efficacy and safety of mirabegron in treatment of primary nocturnal enuresis

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

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 Backup

Study Locations

  • Egypt
    • Qaliopia
      • Banhā, Qaliopia, Egypt, 13518
        • Recruiting
        • Benha University Hospitals
        • Contact:

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

Ages Eligible for Study

1 year to 11 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • primary nocturnal enuresis,
  • negligible daytime wetting,
  • wet at least 4 times over 4 weeks
  • normal clinical examination with no neurological or urological cause for the enuresis

Exclusion Criteria:

  • secondary enuresis, polysymptomatic
  • neurologic bladder, neurological disorders,
  • urinary incontinence disorders
  • previous anti NE drugs.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: patients with primary nocturnal enuresis will be followed up with behavioral therapy alone.
Behavioral: behavioral therapy alone
no medications will be given to the patient
Active Comparator: patients with primary nocturnal enuresis will take desmopressin 120 mcg oral tablets.
Drug: desmopressin 120 mcg oral tablets
treatment for three months then will stop
Active Comparator: patients with PNE will take mirabegron 25 mg oral tablets.
Drug: Mirabegron 25 MG Oral Tablet, Extended Release
treatment for three months then will stop

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
nocturnal enuresis improvement rate
Time Frame: four months
decrease number of nights or absent nights the patient get wet
four months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
side effects of drugs used
Time Frame: three months
appearance of any side effect of desmopressin or mirabegron
three months

Collaborators and Investigators

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

Sponsor

Benha University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

November 23, 2022

Primary Completion (Estimated)

September 1, 2023

Study Completion (Estimated)

October 1, 2023

Study Registration Dates

First Submitted

November 8, 2022

First Submitted That Met QC Criteria

November 8, 2022

First Posted (Actual)

November 15, 2022

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

August 2, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • treatment of primary nocturnal

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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