Overactive Bladder Syndrome and Hypopressive Exercise

January 16, 2025 updated by: Sevgi Özkan, Pamukkale University

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

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?

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Denizli, Turkey, 20160
        • Pamukkale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
The experimental group will receive an online hypopressive exercise training program for 8 weeks.
Behavioral: 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.
No Intervention: Control Group
No special intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overactive Bladder Evaluation Form (OAB-V8)
Time Frame: 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.
At the end of 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overactive Bladder Quality of Life Scale (OAB-q)
Time Frame: At the end of 8 weeks
OAB-q is a quality of life scale consisting of 33 questions that evaluate symptom severity and health-related quality of life in patients with overactive bladder syndrome (OAMS). Each consists of 6 Likert-type options (Never-1, Rarely-2, Sometimes-3, Somewhat often-4, Often-5, Always-6) and 4 subcategories (coping, anxiety, sleep and social relationships). It has a score assessment ranging from 0 to 100. An increase in symptom discomfort indicates an increase in symptom severity, while an increase in quality of life score is a good sign.
At the end of 8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Personal information form
Time Frame: Baseline
The form was designed by researchers to learn the sociodemographic characteristics of women and their pregnancy status (nulliparous, multiparous), number of pregnancies, number of births, type of birth (vaginal, cesarean, vaginal-cesarean), use of cigarettes, alcohol, acidic/carbonated drinks, coffee-nescafe, herbal tea, spicy foods, artificial sweeteners, depression status and physical activity status.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pamukkale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

January 8, 2025

First Submitted That Met QC Criteria

January 16, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 16, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-60116787-020-548394

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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