Combination therapy in recurrence of enuresis

Phase 3

Conditions: Primary monocympetic nocturnal enuresis.
Nacturnal enuresis
N39.44

Registration Number: IRCT20210714051893N1

Lead Sponsor: Qazvin University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 124

Inclusion Criteria

Patients have monosymptomatic primary enuresis.
Patients without any anatomical disorder of kidney in sonography
Patients aged 5 -16 years
Knowledgeably compliance for entry or exit from research

Exclusion Criteria

Patients with enuresis with symptoms of daily urinary disorders, such as urgent urinary incontinence, frequent urination, or reduced urination frequency per day, urinary retention maneuvers during the day.
Patients with urinary tract infection (positive urine culture),
fasting blood sugar,
renal dysfunction (high creatinine),
Anatomical abnormalities of the kidney on ultrasound,
patients previously treated for enuresis
patients with incomplete information, and no referrals
if the child does not have enuresis (has gained control of urination) and later has enuresis
secondary enuresis

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
octurnal enuresis. Timepoint: After starting treatment, patients will be visited monthly. If there is a partial or no response up to two weeks after treatment, possible factors of resistance to treatment such as constipation, bladder disorders or not taking the drug properly will be investigated. Failure to respond to treatment refers to one or more night wetting in two consecutive weeks during treatment and response to treatment is defined as dryness in two consecutive weeks.After three months of treatment, the drugs are discontinued overnight for one month. Re-visits are performed two weeks after treatment and recurrence of nocturnal enuresis (more than three nights wetting per week) will be checked. Method of measurement: Response to treatment questionnaire.

Secondary Outcome Measures

Name	Time	Method
Early enuresis recurrence. Timepoint: En After starting treatment, patients will be visited monthly. If there is a partial or no response up to two weeks after treatment, possible factors of resistance to treatment such as constipation, bladder disorders or not taking the drug properly will be investigated. Failure to respond to treatment refers to one or more night wetting in two consecutive weeks during treatment and response to treatment is defined as dryness in two consecutive weeks.After three months of treatment, the drugs are discontinued overnight for one month. Re-visits are performed two weeks after treatment and recurrence of nocturnal enuresis (more than three nights wetting per week) will be checked. Method of measurement: En Response to treatment questionnaire.