Меню
Набор по приглашению NCT05613153

Peppermint Oil as a Treatment for Children With Bladder and Bowel Dysfunction

Без фазы С лечением Bladder and Bowel Dysfunction

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Peppermint Oil.
Кому может быть актуально
Состояния в реестре: Bladder and Bowel Dysfunction. Базовые параметры: 8 лет — 17 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Peppermint Oil as an Alternative Treatment for Children With Bladder and Bowel Dysfunction: A Prospective Study

Обзор

The goal of this clinical trial is to study the effect of peppermint oil in in children with bladder and bowel dysfunction. The main question it aims to answer is: Does peppermint oil improve symptoms of bladder and bowel dysfunction among children? Participants will: * Be provided peppermint oil capsules to be taken 3 times daily for 8 weeks. * At baseline and at a follow-up visit (8 weeks later), participants will be asked to complete the Vancouver Nonneurogenic Lower Urinary Tract Dysfunction/Dysfunctional Elimination Syndrome Questionnaire. Researchers will compare baseline and follow-up questionnaire data for each participant to determine if there is improvement in symptoms of bladder and bowel dysfunction.

Вмешательства

  • Пищевая добавка Peppermint Oil
    Participants weighing more than 40 kg will receive 2 peppermint oil capsules 3 times a day. Smaller children who weigh between 30 kg and 40 kg will receive 1 capsule of peppermint oil 3 times a day. All subjects will receive 8 weeks of treatment.

Первичные конечные точки

  • Symptom score [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

  • Children aged 8-17 years and weighing 30kg or more with non-neurogenic bladder and bowel dysfunction who have failed behavioral therapy. Behavioral therapy, or also termed standard urotherapy, is defined as encompassing the following components \[15\]: Information and demystification; instruction on avoidance of holding maneuvers, regular bowel habits, proper voiding posture; lifestyle advice encompassing balanced fluid intake and diet, diminished caffeine, regular bladder and bowel emptying patterns; registration of symptoms and voiding habits with bladder diaries or frequency-volume charts; support and encouragement via regular follow up with caregiver. Failure of behavioral therapy is defined as no symptomatology improvement after adherence to behavioral therapy after 6 weeks.
  • Participants must be able to swallow pills

Критерии исключения

  • Patients with neurogenic bladder, tethered cord, Society of Fetal Urology grade 3-4 hydronephrosis, vesicoureteral reflux, learning disabilities, or those who have undergone surgical therapy for bladder and bowel dysfunction will be excluded.
  • Patients on medical therapy with oxybutynin within the last 30 days.
  • Patients with hiatal hernia, severe gastrointestinal reflux or gallbladder disorders or on medications for these conditions will be excluded.
  • Patient weighing less than 30 kg.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Children's Hospital, Orange County — Orange

Публикации

  • Vaz GT, Vasconcelos MM, Oliveira EA, Ferreira AL, Magalhaes PG, Silva FM, Lima EM. Prevalence of lower urinary tract symptoms in school-age children. Pediatr Nephrol. 2012 Apr;27(4):597-603. doi: 10.1007/s00467-011-2028-1. Epub 2011 Oct 4. PMID 21969094
  • Neveus T, von Gontard A, Hoebeke P, Hjalmas K, Bauer S, Bower W, Jorgensen TM, Rittig S, Walle JV, Yeung CK, Djurhuus JC. The standardization of terminology of lower urinary tract function in children and adolescents: report from the Standardisation Committee of the International Children's Continence Society. J Urol. 2006 Jul;176(1):314-24. doi: 10.1016/S0022-5347(06)00305-3. PMID 16753432
  • Jiang R, Kelly MS, Routh JC. Assessment of pediatric bowel and bladder dysfunction: a critical appraisal of the literature. J Pediatr Urol. 2018 Dec;14(6):494-501. doi: 10.1016/j.jpurol.2018.08.010. Epub 2018 Aug 28. PMID 30297226
  • Landgraf JM, Abidari J, Cilento BG Jr, Cooper CS, Schulman SL, Ortenberg J. Coping, commitment, and attitude: quantifying the everyday burden of enuresis on children and their families. Pediatrics. 2004 Feb;113(2):334-44. doi: 10.1542/peds.113.2.334. PMID 14754946
  • Hagglof B, Andren O, Bergstrom E, Marklund L, Wendelius M. Self-esteem before and after treatment in children with nocturnal enuresis and urinary incontinence. Scand J Urol Nephrol Suppl. 1997;183:79-82. PMID 9165615
  • Varlam DE, Dippell J. Non-neurogenic bladder and chronic renal insufficiency in childhood. Pediatr Nephrol. 1995 Feb;9(1):1-5. doi: 10.1007/BF00858952. PMID 7742205
  • Bower WF, Yew SY, Sit KY, Yeung CK. Half-day urotherapy improves voiding parameters in children with dysfunctional emptying. Eur Urol. 2006 Mar;49(3):570-4. doi: 10.1016/j.eururo.2005.12.001. Epub 2006 Jan 4. PMID 16420968
  • Arlen AM. Dysfunctional Voiders-Medication Versus Urotherapy? Curr Urol Rep. 2017 Feb;18(2):14. doi: 10.1007/s11934-017-0656-0. PMID 28213858

Идентификаторы

NCT: NCT05613153 · 2206102

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗