Mirabegron 25 mg for Treatment of Primary Nocturnal Enuresis

NCT05617664 | Unknown

• 1 other identifier: treatment of primary nocturnal
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nocturnal Enuresis

Outcome Measures

Primary Outcomes (1)

• nocturnal enuresis improvement rate

  decrease number of nights or absent nights the patient get wet

  four months

Secondary Outcomes (1)

• side effects of drugs used

  three months

Study Arms (3)

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

PLACEBO COMPARATOR

Behavioral: behavioral therapy alone

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

ACTIVE COMPARATOR

Drug: desmopressin 120 mcg oral tablets

patients with PNE will take mirabegron 25 mg oral tablets.

ACTIVE COMPARATOR

Drug: Mirabegron 25 MG Oral Tablet, Extended Release

Interventions

desmopressin 120 mcg oral tablets DRUG

treatment for three months then will stop

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

Mirabegron 25 MG Oral Tablet, Extended Release DRUG

treatment for three months then will stop

patients with PNE will take mirabegron 25 mg oral tablets.

behavioral therapy alone BEHAVIORAL

no medications will be given to the patient

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

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University Hospitals

Banhā, Qaliopia, 13518, Egypt

RECRUITING

Related Publications (7)

• Bayne AP, Skoog SJ. Nocturnal enuresis: an approach to assessment and treatment. Pediatr Rev. 2014 Aug;35(8):327-34; quiz 335. doi: 10.1542/pir.35-8-327.

  PMID: 25086164 RESULT

• Nitti VW, Rosenberg S, Mitcheson DH, He W, Fakhoury A, Martin NE. Urodynamics and safety of the beta(3)-adrenoceptor agonist mirabegron in males with lower urinary tract symptoms and bladder outlet obstruction. J Urol. 2013 Oct;190(4):1320-7. doi: 10.1016/j.juro.2013.05.062. Epub 2013 May 30.

  PMID: 23727415 RESULT

• Herschorn S, Barkin J, Castro-Diaz D, Frankel JM, Espuna-Pons M, Gousse AE, Stolzel M, Martin N, Gunther A, Van Kerrebroeck P. A phase III, randomized, double-blind, parallel-group, placebo-controlled, multicentre study to assess the efficacy and safety of the beta(3) adrenoceptor agonist, mirabegron, in patients with symptoms of overactive bladder. Urology. 2013 Aug;82(2):313-20. doi: 10.1016/j.urology.2013.02.077. Epub 2013 Jun 13.

  PMID: 23769122 RESULT

• Blais AS, Nadeau G, Moore K, Genois L, Bolduc S. Prospective Pilot Study of Mirabegron in Pediatric Patients with Overactive Bladder. Eur Urol. 2016 Jul;70(1):9-13. doi: 10.1016/j.eururo.2016.02.007. Epub 2016 Feb 11.

  PMID: 26876327 RESULT

• Park JS, Lee YS, Lee CN, Kim SH, Kim SW, Han SW. Efficacy and safety of mirabegron, a beta3-adrenoceptor agonist, for treating neurogenic bladder in pediatric patients with spina bifida: a retrospective pilot study. World J Urol. 2019 Aug;37(8):1665-1670. doi: 10.1007/s00345-018-2576-0. Epub 2018 Dec 3.

  PMID: 30511212 RESULT

• Vande Walle J, Rittig S, Bauer S, Eggert P, Marschall-Kehrel D, Tekgul S; American Academy of Pediatrics; European Society for Paediatric Urology; European Society for Paediatric Nephrology; International Children's Continence Society. Practical consensus guidelines for the management of enuresis. Eur J Pediatr. 2012 Jun;171(6):971-83. doi: 10.1007/s00431-012-1687-7. Epub 2012 Feb 24.

  PMID: 22362256 RESULT

• Neveus T, Fonseca E, Franco I, Kawauchi A, Kovacevic L, Nieuwhof-Leppink A, Raes A, Tekgul S, Yang SS, Rittig S. Management and treatment of nocturnal enuresis-an updated standardization document from the International Children's Continence Society. J Pediatr Urol. 2020 Feb;16(1):10-19. doi: 10.1016/j.jpurol.2019.12.020. Epub 2020 Jan 30.

  PMID: 32278657 RESULT

MeSH Terms

Conditions

Nocturnal Enuresis

Interventions

Deamino Arginine Vasopressin; mirabegron; Tablets; Behavior Therapy

Condition Hierarchy (Ancestors)

Enuresis; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Arginine Vasopressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Dosage Forms; Pharmaceutical Preparations; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

hosam abu el-nasr, MD

CONTACT

01286296939; hosamabuelnasr@gmail.com

mohamed al hefnawy, MD

CONTACT

01003481084; dr.mohamedalhefnawy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of urology

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: November 15, 2022
• Study Start: November 23, 2022
• Primary Completion: September 1, 2023
• Study Completion: October 1, 2023
• Last Updated: August 3, 2023

Record last verified: 2023-08

Locations

EG (1)