A study of donepezil hydrochloride for dysuria in Down syndrome

JRCT ID: jRCTs071180032

Registered date:06/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Dysuria of the people with Down syndrome
• Date of first enrollment: 19/03/2018
• Target sample size: 48
• Study type: Interventional
• Intervention(s): Medicine

Outcome(s)

• Primary Outcome: Change in maximum urinary flow rate (Qmax
• Secondary Outcome: Changes in average urinary flow rate (AFR), urinary patterns, residual urine volume, urinary frequency, frequency of urinary incontinence, defecation patterns, and activities of daily life

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Age: Patients with Down syndrome aged 12 years old or above at the time when consent is obtained.
Gender: Both male and female.
Inpatients/Outpatients: Only outpatients.
Dysuria is defined as any of the following: 1) a postvoid residual urine 20% or more of voided urine volume or 50 mL or more; 2) Qmax less than -1SD (Siroky's nomogram) in uroflowmetry; and 3) urinary frequency of twice or less per day. 4)Average urinary volume more than 600ml.
Patients and their family or guardian must voluntarily give a written consent to participation in this study with full understanding after sufficient explanation.
Only patients who have been under other medical treatment for dysuria with an insufficient effect are eligible for this study.

Exclude criteria

Any of the following patients will be excluded:
1) those who have already taken any acetylcholinesterase inhibitor with high CNS selectivity, including Aricept
2) those with serious liver or kidney dysfunction
3) those with drug hypersensitivity
4) those who have been in remission on other medical therapy such as Urapidil
5) those who have been on treatment with other therapeutic agent(s) for dysuria
6) those who need to change therapeutic strategy within 8 weeks of the single-blind study
7) those whom principal investigator judged as inappropriate for this study.

Related Information

• Primary Sponsor: Moriuchi Hiroyuki
• Secondary Sponsor: Donation from the Down syndrome supporting group
• Secondary ID(s): UMIN000030570