Efficacy and Safety of Mirabegron Versus Oxybutynin After Posterior Urethral Valve Ablation
Efficacy and Safety of Mirabegron Versus Oxybutynin After Posterior Urethral Valve Ablation: A Comparative Prospective Randomized Study
연구 개요
상세 설명
Posterior urethral valve is the main cause of bladder outlet obstruction in male infants and the most common cause of obstructive uropathy leading to chronic renal failure and end-stage renal disease in children.The incidence of posterior urethral valve is approximately 1:7,000-8,000 live births.
Anatomically, it is a membrane starting at the verumontanum and attached distally in the posterior urethra in the male child, resulting in valve like obstruction to the urine outflow leading to harmful effects on the urinary bladder and the upper urinary tracts.
Initial management of children with posterior urethral valves is immediate bladder drainage followed by endoscopic posterior urethral valve ablation. However, despite the early relief of bladder outlet obstruction, remaining pathological changes in the urinary bladder can lead to significant bladder dysfunction which leads to impaired upper tract drainage; valve bladder syndrome.
Oxybutynin is primarily indicated for the treatment of overactive bladder syndrome. It is still the most widely prescribed drug for overactive bladder in the world. It has been demonstrated to be safe for administration in the paediatric neurogenic bladder population.
Mirabegron, a beta-3 adrenergic agonist has been used for the treatment of overactive bladder symptoms as an alternative to anticholinergics with minimal side effects. Few studies stated safety of mirabegron in pediatric population with overactive bladder.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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South Valley
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Qina, South Valley, 이집트
- Qina University hospital, South Valley University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- All children older than 3 years old who have undergone posterior urethral valve ablation
Exclusion Criteria:
- Children younger than 3 years old.
- Children with residual valve.
- Children who had undergone urinary diversion (vesicostomy or ureterostomy).
- Children with other conditions that can potentially affect upper or lower urinary tract function (spina bifida, anorectal malformation,prune belly syndrome).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Group A (Mirabegron Tablets):
About 26 children suffering from Valve Bladder Syndrome after posterior urethral valve ablation and will be maintained on Mirabegron tablets (0.5-1 mg/kg/daily) orally.
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To assess the efficacy and the safety of Mirabegron and Oxybutynin drugs after posterior urethral valve ablation regarding: the Effect on upper and lower urinary tract and Febrile UTI recurrence.
다른 이름들:
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활성 비교기: Group B (Oxybutynin Tablets):
About 26 children suffering from Valve Bladder Syndrome after posterior urethral valve ablation and will be maintained on Oxybutynin Syrup (0.2 mg/kg 3 times per day) orally.
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To assess the efficacy and the safety of Mirabegron and Oxybutynin drugs after posterior urethral valve ablation regarding: the Effect on upper and lower urinary tract and Febrile UTI recurrence.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Efficacy of Mirabegron and Oxybutynin on upper and lower urinary tract
기간: 6 Months
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Assessment the drugs used on the upper and lower urinary tract after posterior urethral valve ablation in children by using shape,wall, reflux and diverticuli (SWRD) score from 0 to 7 where as 0 is better improvement but 7 is worsen improvement .
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6 Months
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Safety of Mirabegron usage after posterior urethral valve ablation by measuring arterial blood pressure
기간: 6 Months
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Assessment of the safety of Mirabegron drug in children after posterior urethral valve ablation by measuring arterial blood pressure by Mercury Sphygmomanometer (mmHg )
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6 Months
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Safety of Mirabegron usage after posterior urethral valve ablation by measuring heart rate
기간: 6 Months
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Assessment of the safety of Mirabegron drug in children after posterior urethral valve ablation by measuring heart rate by pulse oximeter (beat per minute).
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6 Months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Urinary tract infection Recurrency
기간: 6 Months
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Assessment of Efficacy of Mirabegron and Oxybutynin on reduction of the rate of Urinary tract infection by assessment of presence of significant pyuria in urine analysis.
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6 Months
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공동 작업자 및 조사자
수사관
- 연구 의자: Ahmad Abolyosr Mohamed, Professor, Professor of Urology, Faculty of medicine,South Valley University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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