RANDOMIZED CONTROL TRIAL COMPARING RESPONSE RATES BETWEEN DESMOPRESSIN ALONE AND COMBINATION OF SOLIFENACIN PLUS DESMOPRESSIN IN CHILDREN WITH PRIMARY MONOSYMPTOMATIC NOCTURNAL ENURESIS

Ahmad T1, Minallah N2

Research Type

Clinical

Abstract Category

Paediatrics

Abstract 715
Late Breaking Abstracts
Scientific Podium Session 39
Thursday 28th September 2023
08:45 - 09:00
Room 104CD
Nocturnal Enuresis Pediatrics Incontinence
1. Khyber Teaching Hospital, Peshawar, Khyberpakhtunkhwa, Pakistan, 2. Pakistan Kidney and Liver Institute & Research Centre, Lahore, Punjab, Pakistan
Presenter
Links

Abstract

Hypothesis / aims of study
To compare the efficacy of Solifenacin plus Desmopressin and Desmopressin alone in the treatment of primary monosymptomatic nocturnal enuresis

To compare the tolerability of Solifenacin plus Desmopressin and Desmopressin alone in the treatment of primary monosymptomatic nocturnal enuresis
Study design, materials and methods
This randomized control trial was conducted from June 2017 to June 2022. It consisted of 180 children, ages 5–14, diagnosed with PMNE. Patients with urinary tract infection (UTI), elevated serum creatinine, history of constipation, post-void residual urine on ultrasound, and neurogenic conditions were excluded from the study. After informed written consent, patients were randomly assigned to one of the two therapeutic groups. Group 1 received one puff of desmopressin nasal spray an hour before bedtime every night. Group 2 received one pill of solifenacin (5 mg) plus one puff of desmopressin nasal spray one hour before bedtime every night. All patients were evaluated after three months for their response to treatment and drug side effects.
Complete response, partial response and non-response were defined as 90–100%, 50–89% and < 50% decrease in the number of nighttime wetting.
Recurrence was defined as the recurrence of more than one night wettings during the three month follow up, as reported by the family.
A frequency volume chart (FVC) was used to measure the night time wettings.
Results
The mean ages in the desmopressin alone group and the solifenacin plus desmopressin group were 8.1 +/- 2.2 and 7.9 +/- 2.2 years, respectively (p-value > 0.05). In group 2, 76/90 (84.4%) patients achieved complete response after three months of treatment in comparison to group 1 in which 55/90 (61.1%) patients showed complete response (p-value < 0.05). In group 1, 14/90 (15.6%) patients developed treatment-related side effects, whereas in group 2, 23/90 (25.6%) patients developed side effects (p-value > 0.05). No case of discontinuation of treatment due to side effects was observed in either of the two groups. The recurrence rate was also significantly lower in group 2 in comparison to group 1 (8.9% vs. 24.4%, p-value < 0.05).
Interpretation of results
The combination of Desmopressin and solifenacin is more effective than desmopressin alone
Combination therapy is associated with a higher rate of side effects than monotherapy; however, the difference is not significant.
The reccurence rate is also significantly lower in patients using the combination therapy in comparison to those using monotherapy.
Concluding message
Our study demonstrated that the combination of Solifenacin plus desmopressin is more effective than desmopressin monotherapy in the treatment of PMNE with an acceptable tolerability profile.
Disclosures
Funding None Clinical Trial Yes Public Registry No RCT Yes Subjects Human Ethics Committee IREB of Khyber Teaching Hospital Helsinki Yes Informed Consent Yes
14/11/2024 03:23:54