Effect Of Abdominal Hypopressive Training On Stress Urinary Incontinence

March 4, 2025 updated by: Doaa Saeed Mohamed, Badr University

Effect Of Abdominal Hypopressive Training On Stress Urinary IncontinenceIn Female Athletes

Fifty female athletes suffering from stress incontinence (SUI) will participate in this study. They will be selected from El Zohour Club, New Cairo City.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

They will be randomly distributed into 2 groups equal in numbers:

Group (A) (Control group) consists of 25 female athletes. They will receive nutritional instructions and pelvic floor muscle exercises three sessions/week for 3 months.

Group (B) (Study group) consists of 25 female athletes. They will receive the same treatment for the control group and abdominal hypopressive exercises three sessions/week of 30 mins per week for 3 months.

Before data collection, the purpose and procedures will be fully explained to the females. Informed consent will be obtained from each female. Each female will be evaluated following a standard protocol.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Egypt
    • Cairo
      • New Cairo, Cairo, Egypt, 470001
        • El Zohour Club

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Female athletes suffering from SUI.
  2. They will be diagnosed with SUI using bladder stress test.
  3. Their ages will range from 14-18 years old.
  4. Their body mass index (BMI) will range from 18.5-24.9 kg/m2.
  5. They are single females.

Exclusion Criteria:

The female athlete will be excluded if they had:

  1. Urinary tract infection.
  2. Family history of genito-urinary tract cancer.
  3. Diabetes mellitus.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group (A) (Control group)
consists of 25 female athletes. They will receive nutritional instructions and pelvic floor muscle exercises three sessions/week for 3 months.
Other: pelvic floor exercises, nutritional instructions
They will receive nutritional instructions and pelvic floor muscle exercises three sessions/week for 3 months.
Experimental: Group (B) (Study group)
consists of 25 female athletes. They will receive the same treatment for the control group and abdominal hypopressive exercises three sessions/week of 30 mins per week for 3 months.
Other: abdominal hypopressive exercises, pelvic floor exercises, nutritional instructions
consists of 25 female athletes. They will receive the same treatment for the control group and abdominal hypopressive exercises three sessions/week of 30 mins per week for 3 months.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assessment of urine loss
Time Frame: 24 hours pad test for12 weeks
Pad testing will be used to quantify the volume of urine loss by weighing an absorbent pad before and after some type of leakage provocation. The test will start with weighting clean empty pad in grams. Then, it will be used until next time and weighted again. The weight of the used pad will be subtracted from the weight of the empty pad so the net result will determine the amount of leakage.
24 hours pad test for12 weeks
assesment of pelvic floor muscle contraction and tonning
Time Frame: 12 weeks
The measurements will be taken in crock-lying position with a full bladder, neutral lumbar spine. The ultrasound transducer will be inserted transversely directly superior to the symphysis pubis, probe is tilted 60 degrees from vertical (Arab, 2010). Every female will perform 3 maximal PFM contractions so that displacement of the bladder wall, because of a PFM contraction, could be measured.
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of symptoms and health related quality of life
Time Frame: 12 weeks
The ICIQ-SF will be used in assessment of each female in both groups. It is used to measure severity and impact of UI on the quality of life in women. The ICIQ-SF is formed of six items of which four main items ask for rating of UI symptoms in the past 4 weeks. A score of zero means no leakage of urine and no affection on quality of life. (Question 1): quantifies the frequency of urinary leaking, (question 2): evaluates the amount of leaking and (question 3): how much the urinary incontinence interferes with everyday life (Hilton and Robinson, 2011). The scores for items 3, 4 and 5 are taken for the final ICIQ-SF score. Items 1 and 2 are demographic and the final item is a self-diagnostic item for the type of UI. ICIQ- SF (range 0-21) is given four scoring categories: slight (1-5), moderate (6-12), severe (13-18) and very severe (19-21).
12 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Badr University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Abeer ElDeeb, Professor, PROFESSOR DOCTOR

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 20, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 20, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 22, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P.T.REC/012/004947

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

not sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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