Phase
Condition
Urinary Incontinence
Frequent Nighttime Urination (Nocturia)
Enuresis
Treatment
N/AClinical Study ID
Ages 6-15 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosed nocturnal enuresis with reduced nighttime urinary osmolality
Age 6 or above but under 16 regardless of gender
Out-patient
Had 10 or more wet nights during the 14-day baseline period and at least 4 wet nightsin each respective week
Deemed healthy by the investigator
Able to agree to and comply with fluid-intake restriction during the clinical trialand matters specified in the clinical trial protocol
Consent from the pediatric patient's legally acceptable representative
Demonstrate an understanding about this clinical trial after receiving an explanationcorresponding to the prospective subject's intelligibility
Show no possibility of being a nursing mother or pregnant, or becoming pregnant
If under drug or medical therapy other than Desmopressin for treating nocturnalenuresis: able to discontinue such treatment
Exclusion
Exclusion Criteria:
Suffer from enuresis with an underlying disease
Participated in another clinical trial within six months preceding consent
Used an intranasal Desmopressin in the past
Presently undergoing a systemic antibiotic treatment, a treatment with an antidiureticor a drug that affects urinary concentration, or a drug or medical therapy foroveractive bladder
Have an anomaly or a disease that may affect the oral absorption of drug products
Hard to get cooperation from subject by school refusal, punishment or bullying
Deemed by the investigator to be inappropriate to participate in this trial
Unable to be placed on water-intake restriction starting from two hours before bedtime
Evidence of hepatic, renal, cardiac, or pulmonary dysfunction
Study Design
Connect with a study center
Showa Hospital
Amagasaki, Hyogo
JapanSite Not Available
Shinko-Kakogawa Hospital
Kakogawa, Hyogo
JapanSite Not Available
Tamura Children's Clinic
Mito, Ibaraki
JapanSite Not Available
Shinbo Child Clinic
Yokohama, Kanagawa
JapanSite Not Available
Kansai Medical University Hirakata Hospital
Hirakata, Osaka
JapanSite Not Available
Takesue Children's Clinic
Musashino, Tokyo
JapanSite Not Available
Juntendo University Nerima Hospital
Nerima, Tokyo
JapanSite Not Available
Saitoh Pediatric Medical Clinic
Nishi-Tokyo, Tokyo
JapanSite Not Available
Hoashi Children's Psychological Clinic
Setagaya, Tokyo
JapanSite Not Available
Akita University Hospital
Akita,
JapanSite Not Available
Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
Hiroshima,
JapanSite Not Available
Aikawa Station Clinic
Niigata,
JapanSite Not Available
Kitano Hospital
Osaka,
JapanSite Not Available
Saitama Childrens Medical Centre
Saitama,
JapanSite Not Available
Shintoshin Child Clinic
Saitama,
JapanSite Not Available
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