The Safety and Efficacy of Fluoxetine for Refractory Primary Mono-symptomatic Nocturnal Enuresis in Children

Nocturnal Enuresis Clinical Trial

Official title:

The Safety and Efficacy of Selective Serotonin Reuptake Inhibitors, Fluoxetine, for Refractory Primary Mono-symptomatic Nocturnal Enuresis in Children: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04676139
• Other study ID #: SSRI & Nocturnal enuresis
• Status: Recruiting
• Phase: Phase 3
• Start date: July 1, 2020
• Est. completion date: December 2022

Study information

• Verified date: December 2020
• Source: Mansoura University
• Contact: Mohamed Hussiny abdelazim
• Phone: 01064156383
• Email: mohamedhussiny1[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine whether there is a role for the selective serotonin reuptake inhibitors, fluoxetine, as therapy in the treatment of refractory primary monosymptomatic nocturnal enuresis in children , and whether there are side effects involved.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

• Primary Monosymptomatic nocturnal enuresis

• Failed treatment with desmopressin.

• The enuresis alarm had either been tried without effect, or deemed unfeasible because of the family situation.

• All patients had either tried and failed combination therapy with anticholinergics or, because of contraindications, been unable to receive such therapy.

• Severe enuresis with at least seven wet nights out of 14

Exclusion Criteria:

• Underlying renal, urologic, neurologic, endocrinologic, or cardiac conditions

• Depression

• Severe psychiatric diseases

• Untreated constipation

Related Conditions & MeSH terms

• Enuresis
• Nocturnal Enuresis
• Urinary Incontinence

Intervention

Drug:
• Fluoxetine
Fluoxetine 10 mg capsules once daily for 12 months
• Placebo
placebo for 12 months

Locations

Country	Name	City	State
Egypt	Mansoura urology and nephrology center	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Neveus T, Eggert P, Evans J, Macedo A, Rittig S, Tekgül S, Vande Walle J, Yeung CK, Robson L; International Children's Continence Society. Evaluation of and treatment for monosymptomatic enuresis: a standardization document from the International Children — View Citation

Nevéus T. Pathogenesis of enuresis: Towards a new understanding. Int J Urol. 2017 Mar;24(3):174-182. doi: 10.1111/iju.13310. Epub 2017 Feb 16. Review. — View Citation

Song P, Huang C, Wang Y, Wang Q, Zhu W, Yue Y, Wang W, Feng J, He X, Cui L, Wan T, Wen J. Comparison of desmopressin, alarm, desmopressin plus alarm, and desmopressin plus anticholinergic agents in the management of paediatric monosymptomatic nocturnal en — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assess efficacy Selective Serotonin Reuptake Inhibitors, Fluoxetine, for refractory Primary Mono-symptomatic Nocturnal Enuresis in children.	counting the wet nights numbers between baseline and after 2 weeks of each treatment period	6 months
Secondary	assess the safety of Selective Serotonin Reuptake Inhibitors, Fluoxetine, for refractory Primary Mono-symptomatic Nocturnal Enuresis in children.	by counting the numbers of complication of each drugs	6 months