Ignite Creation Date:
2025-12-24 @ 6:46 PM
Ignite Modification Date:
2025-12-25 @ 4:18 PM
Study NCT ID:
NCT06780657
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-01-17
First Post:
2025-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Overactive Bladder Syndrome and Hypopressive Exercise
Sponsor:
Pamukkale University
Organization:
Study Overview
Official Title:
The Effect of Hypopressive Exercise on Overactive Bladder Syndrome and Quality of Life
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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?
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?
Detailed Description:
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).
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: