Clinical trial

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

Name

treatment of primary nocturnal

Description

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

Trial arms

Trial start

2022-11-23

Estimated PCD

2023-09-01

Trial end

2023-10-01

Status

Recruiting

Treatment

desmopressin 120 mcg oral tablets

treatment for three months then will stop

Arms:

patients with primary nocturnal enuresis will take desmopressin 120 mcg oral tablets.

Mirabegron 25 MG Oral Tablet, Extended Release

treatment for three months then will stop

Arms:

patients with PNE will take mirabegron 25 mg oral tablets.

behavioral therapy alone

no medications will be given to the patient

Arms:

patients with primary nocturnal enuresis will be followed up with behavioral therapy alone.

Size

150

Primary endpoint

nocturnal enuresis improvement rate

four months

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}

Updated at

2023-08-03

1 organization

2 products

1 indication

Organization

Product

Indication

Product