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Status unknownNCT06185361Updated Dec 29, 2023

Selective Serotonin Reuptake Inhibitors, Fluoxetine Versus the Standard Oral Desmopressin for Management of Mono-symptomatic Nocturnal Enuresis.

An interventional study of Fluoxetine 20 MG and Desmopressin in Nocturnal Enuresis, Enuresis and Enuresis, Nocturnal, sponsored by Fayoum University Hospital. Status unknown at 1 site in Egypt. Open to participants aged 8 Years to 16 Years. Per ClinicalTrials.gov, last updated 2023-12-29.

Sponsored by Fayoum University Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2023), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Dec 2022, registered Dec 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
8 Years to 16 Years
Sex
All
01

Study summary

To determine whether there is a role for the selective serotonin reuptake inhibitors fluoxetine versus desmopressin in the treatment of nocturnal enuresis in children who have not responded to standard nonpharmacological urotherapy, and whether there are side effects involved.

02

Conditions studied

  • Nocturnal Enuresis
  • Enuresis
  • Enuresis, Nocturnal
03

In context

Nocturnal Enuresis

102 studies on the registry are indexed under Nocturnal Enuresis; 21 are open to participants now.

This study's enrollment of 60 is close to the median of 64 across 75 interventional studies indexed under Nocturnal Enuresis.

Browse Nocturnal Enuresis studies →

Lead sponsor

Fayoum University Hospital is the lead sponsor of 76 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥ 7 years
  2. Severe enuresis with at least (50%) seven wet nights out of 14
  3. Failed treatment
  4. The enuresis alarm was either ineffective or considered impractical due to the family circumstances.

Exclusion criteria

Exclusion Criteria:

  1. Underlying renal, urologic, neurologic, endocrinologic, or cardiac conditions
  2. Patients with psychiatric disorders and behavioral disorders including depression, attention-deficit/hyperactivity disorder.
  3. Untreated constipation
  4. Contraindications to fluoxetine or desmopressin treatment
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    fluoxetine

    selective serotonin reuptake inhibitors fluoxetine 20 mg for 12 weeks

    Drug: Fluoxetine 20 MG

  • Active comparator
    desmopressin

    0.2 mg desmopressin tablet for 12 weeks

    Drug: Desmopressin

Interventions

06

What researchers measure

Primary outcomes

  1. The children will be non-responders, partial responders, or full responders to therapy

    The standardization of terminology of lower urinary tract function in children and adolescents: Update report from the standardization committee of the International Children's Continence Society "ICCS definitions" (i.e., if the reduction of enuresis frequency was below or above 50% or 90%, respectively)

    Time frame: three months

07

Study locations

1 site
  • Faculty of medicine, Fayoum University
    Al Fayyum, 63514, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2022 (actual). Primary completion is estimated for Mar 2024, 15 months after the start.

Of 37 interventional studies with no phase under Nocturnal Enuresis, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 49. This study's planned 15 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 15, 2023
First posted
Dec 29, 2023
StartActual
Dec 1, 2022
Primary completionEst.
Mar 1, 2024
CompletionEst.
Mar 1, 2024
Last update
Dec 29, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06185361
Lead sponsor
Fayoum University Hospital
Responsible party
Hesham Abdel Azim El Helaly (Assistant Professor, Fayoum University Hospital) — Principal investigator
First posted
Dec 29, 2023
Start date
Dec 1, 2022
Primary completion
Mar 1, 2024 (estimated)
Completion
Mar 1, 2024 (estimated)
Last update
Dec 29, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Fluoxetine · Deamino Arginine Vasopressin

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Other studies from this sponsor

Fayoum University Hospital

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