跳至主要内容
临床试验/NCT06780657
NCT06780657Enrolling By Invitation不适用

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

Pamukkale University1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2024年8月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
112
试验地点
1
主要终点
Overactive Bladder Evaluation Form (OAB-V8)

研究概览

简要总结

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?

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

Single

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Experimental Group

Experimental

The experimental group will receive an online hypopressive exercise training program for 8 weeks.

干预措施: Online hypopressive exercise training program (Behavioral)

Control Group

No Intervention

No special intervention.

结局指标

主要结局

Overactive Bladder Evaluation Form (OAB-V8)

时间窗: At the end of 8 weeks

It is a scale consisting of 8 questions, each with 6 options on a Likert type scale (Not at all-0, very little-1, a little-2, a lot-3, a lot-4, a lot-5) to question the presence of Overactive Bladder Syndrome. The total score is between 0-40. Accordingly, those with a total score of \>11 are classified as Overactive Bladder Syndrome patients.

次要结局

  • Overactive Bladder Quality of Life Scale (OAB-q)(At the end of 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sevgi Özkan

Dean of Health Sciences, Professor

Pamukkale University

研究点 (1)

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