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Набор по приглашению NCT06780657

Overactive Bladder Syndrome and Hypopressive Exercise

Без фазы С лечением Overactive Bladder Syndrome

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: Online hypopressive exercise training program.
Кому может быть актуально
Состояния в реестре: Overactive Bladder Syndrome. Базовые параметры: 18 лет — 65 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Effect of Hypopressive Exercise on Overactive Bladder Syndrome and Quality of Life

Обзор

Overactive Bladder Syndrome (OAB) is a condition characterized by a sudden and urgent need to urinate, with or without urge incontinence, accompanied by increased urinary frequency. This syndrome significantly impacts individuals' social and economic lives, psychological well-being, work productivity, daily activities, and overall quality of life. The Abdominal Hypopressive Technique (AHT) was suggested by Caufriez for the treatment of pelvic floor disorders in women. It has been utilized in the treatment of pelvic floor dysfunctions, such as Urinary Incontinence (UI), particularly in postpartum women. A review of the existing literature reveals a lack of studies examining the relationship between overactive bladder syndrome and hypopressive exercises. Current research predominantly focuses on the effects of hypopressive exercises on pelvic organ prolapse, pelvic floor muscle tone, urinary incontinence, and stress urinary incontinence. Although AHT was initially developed for the treatment of pelvic floor disorders, it is now recommended for all women, regardless of the presence of UI. However, studies on AHT remain limited, which poses challenges for its broader scientific application. This highlights the need for robust scientific studies to strengthen the evidence base. The present study aims to evaluate the impact of an online hypopressive exercise training program on overactive bladder syndrome symptoms and quality of life. The main questions it aims to answer are: * Does online hypopressive exercise training effectively reduce the symptoms of overactive bladder syndrome? * Does online hypopressive exercise training effective in improving the quality of life among women with overactive bladder syndrome?

Подробное описание

The study was designed as a prospective, single-blind, randomized controlled experimental trial with a pretest-posttest control group design. The study sample consisted of women diagnosed with Overactive Bladder Syndrome (OAB) who applied to the Urology Outpatient Clinic of Pamukkale University Hospital and those reached via social media (scoring above 11 on the Overactive Bladder Screening Form \[OAB-V8\]). Eligibility was determined using a personal information form, the Overactive Bladder Screening Form (OAB-V8), and the Overactive Bladder Quality of Life Questionnaire (OAB-q).

The contact information of women in the experimental and control groups was collected, and data were gathered through Google Forms, with online communication established via messaging. To reach participants through social media, a poster was prepared, and the online hypopressive exercise training program was announced. All participants were verbally informed about the study via the details provided in the informed consent form, and verbal consent was obtained. Additionally, an explanation was provided in the initial section of the data form, and women who agreed to participate clicked "I voluntarily agree to participate in the study" to access the form.

The sample size was calculated using the G Power 3.1.9.4 software with an a priori power analysis. Considering a power of 80% and a 10% excess for potential sample loss, a minimum of 56 participants per group was determined. Simple randomization was used for this study.

The hypopressive exercises used in this study were determined based on recommendations from the literature and consultation with an expert in the field. Participants in the experimental group were asked to complete the relevant scales via Google Forms before starting the online hypopressive exercise training (pretest). They were then instructed to perform the exercises twice a week for 20-25 minutes over eight weeks, repeating each exercise 10 times per session by the end of the program. They were also asked to mark their progress on an 8-week exercise diary. After the eight weeks, they were requested to complete the same scales via Google Forms again (posttest).

Participants in the control group were asked to maintain their usual physical activities and continue with their normal daily lives. At the end of the eight weeks, they were also requested to complete the same scales via Google Forms (posttest).

The outcomes were measured at the start of the intervention and after eight weeks. Data were collected using the personal information form, the Overactive Bladder Screening Form (OAB-V8), and the Overactive Bladder Quality of Life Questionnaire (OAB-q).

Вмешательства

  • Поведенческое Online hypopressive exercise training program
    The hypopressive exercises were based on recommendations from the literature and consultation with an expert in the field. Each session will be held twice a week for 20-25 minutes. Participants will perform each exercise 10 times during these sessions.

Первичные конечные точки

  • Overactive Bladder Evaluation Form (OAB-V8) [Срок оценки: At the end of 8 weeks]
Вторичные конечные точки (1)
  • Overactive Bladder Quality of Life Scale (OAB-q) [Срок оценки: At the end of 8 weeks]

Критерии участия

Критерии включения

  • No contraindications to performing hypopressive exercises,
  • Voluntary participation in the study,
  • Being between 18 and 65 years of age,
  • Having access to the internet,
  • Ability to speak and understand Turkish.

Критерии исключения

  • Individuals with lower back pain,
  • Those with uncontrolled hypertension,
  • Individuals with hiatal hernia,
  • Those with a history of inguinal hernia,
  • Pregnant individuals,
  • Those diagnosed with COPD,
  • Individuals with neuromuscular disorders,
  • Those who have undergone abdominal or pelvic surgery,
  • Prior experience with hypopressive exercises.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр
  • Pamukkale University — Denizli

Публикации

  • Resende APM, Bernardes BT, Stupp L, Oliveira E, Castro RA, Girao MJBC, Sartori MGF. Pelvic floor muscle training is better than hypopressive exercises in pelvic organ prolapse treatment: An assessor-blinded randomized controlled trial. Neurourol Urodyn. 2019 Jan;38(1):171-179. doi: 10.1002/nau.23819. Epub 2018 Oct 12. PMID 30311680
  • Navarro Brazalez B, Sanchez Sanchez B, Prieto Gomez V, De La Villa Polo P, McLean L, Torres Lacomba M. Pelvic floor and abdominal muscle responses during hypopressive exercises in women with pelvic floor dysfunction. Neurourol Urodyn. 2020 Feb;39(2):793-803. doi: 10.1002/nau.24284. Epub 2020 Jan 27. PMID 31985114
  • Soriano L, Gonzalez-Millan C, Alvarez Saez MM, Curbelo R, Carmona L. Effect of an abdominal hypopressive technique programme on pelvic floor muscle tone and urinary incontinence in women: a randomised crossover trial. Physiotherapy. 2020 Sep;108:37-44. doi: 10.1016/j.physio.2020.02.004. Epub 2020 Feb 19. PMID 32707289
  • Molina-Torres G, Moreno-Munoz M, Rebullido TR, Castellote-Caballero Y, Bergamin M, Gobbo S, Hita-Contreras F, Cruz-Diaz D. The effects of an 8-week hypopressive exercise training program on urinary incontinence and pelvic floor muscle activation: A randomized controlled trial. Neurourol Urodyn. 2023 Feb;42(2):500-509. doi: 10.1002/nau.25110. Epub 2022 Dec 8. PMID 36482844
  • Jose-Vaz LA, Andrade CL, Cardoso LC, Bernardes BT, Pereira-Baldon VS, Resende APM. Can abdominal hypropressive technique improve stress urinary incontinence? an assessor-blinded randomized controlled trial. Neurourol Urodyn. 2020 Nov;39(8):2314-2321. doi: 10.1002/nau.24489. Epub 2020 Aug 19. PMID 32813928
  • Ithamar L, de Moura Filho AG, Benedetti Rodrigues MA, Duque Cortez KC, Machado VG, de Paiva Lima CRO, Moretti E, Lemos A. Abdominal and pelvic floor electromyographic analysis during abdominal hypopressive gymnastics. J Bodyw Mov Ther. 2018 Jan;22(1):159-165. doi: 10.1016/j.jbmt.2017.06.011. Epub 2017 Jun 21. PMID 29332741

Идентификаторы

NCT: NCT06780657 · E-60116787-020-548394

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗