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Effect of Laser Acupuncture for Treating Monosymptomatic Nocturnal Enuresis in Adolescent Females

Plain-language guide to NCT05399173: not phased randomized trial of Desmopressin, 60 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05399173
Phase
not phased
Status
status unknown
Start
2022-06-02
Completion (planned or actual)
2023-09-08
Participants
60 (estimated)
Design
randomized, double-blind, treatment
Conditions studied
Non-Specific Urethritis
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Desmopressin.

The aim of this study is to evaluate the effect of laser acupuncture on monosymptomatic nocturnal enuresis in adolescent females.

It had two arms (groups): an infrared (gallium aluminum arsenide laser) (experimental) and conventional therapy (active comparator).

The registry classes the interventions as device and drug.

More on the Plan

Nocturnal enuresis (NE) can be defined as the involuntary passage of urine during sleep beyond the age of anticipated nighttime bladder control, which is generally accepted as 5 years of age.

Studies show that enuretic children have lower self-esteem than healthy children.

Even among chronic illnesses, enuresis has more negative effect on children's mental and social health .

Most of the studies highlighted that persisting NE was a high risk of psychosocial comorbidity and negatively affects the quality of life.

Who Took Part

The registry lists 60 planned participants were the target.

It was open to women only aged from 10 years up to 18 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adolescent females have to meet the following criteria in order to participate in this study:. Suffering from Monosymptomatic nocturnal enuresis. Their ages will range from 10-18 years. Resistance to medical treatment (desmopressin acetate).

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: adolescent females with the following criteria will be excluded from this study:; psychological or neurological disorders or other organic disorders; any chronic diseases.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Desmopressin and who got the comparison, which limits bias.

The Desmopressin group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Desmopressin.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2022-06-02 with completion listed for 2023-09-08.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): bladder capacity (time frame: up to 6 weeks).

It also tracked 2 secondary outcomes, for example Maximum voided volume and Frequency of bed wet.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Desmopressin in 60 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Desmopressin compound page, all human trials.

Our Notes on the Compound

Desmopressin: A synthetic vasopressin analog (DDAVP) used for bedwetting, diabetes insipidus and some bleeding disorders.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.