Abdominal-Kegel Exercise and the Effect of Telemedicine in Stress Urinary Incontinence

December 19, 2023 updated by: SEVDA SUNGUR, Eskisehir Osmangazi University

Abdominal-Kegel Exercise in Patients With Stress Urinary Incontinence and the Effect of Telemedicine Applications on Adaptation to Lifestyle Changes: A Randomized Controlled Study

Urinary incontinence is a very common health problem that reduces the quality of life mostly in women. Behavioral therapy (lifestyle changes, abdominal-Kegel exercises) is recommended as the first choice in the treatment of the disease. It is known that surgical and medical treatment cannot give a definite result. The application of behavioral therapy with telemedicine has advantages such as reducing the cost and increasing the treatment rate. In this study, it is aimed to evaluate the effect of telemedicine practices on compliance with multi-module behavioral therapy in women with stress urinary incontinence.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The study is a randomized controlled study to be conducted in female patients between the ages of 20-65 who applied to the Eskişehir City Hospital urology outpatient clinic and diagnosed with stress urinary incontinence.

When type 1 (α) error was 5%, type 2 error (1-β) was 95%, and the effect size was accepted as 0.5, it was calculated that there should be at least 47 people in the groups.

Stratified and block randomization will be used to recruit patients into study groups.

The patients will be evaluated with the QUID test, risk assessment questionnaire in patients with stress urinary incontinence, incontinence short test, bladder diary, daily urinary incontinence, a notebook to record the duration of the exercises to be performed, quality of life scale and lifestyle changes questioning form.

The intervention group will be re-evaluated as a result of the intervention with measurement tools.

Intervention group: Brochure about incontinence will be given, web-based training will be applied, SMS will be sent every day according to the risks.

Control group: Only brochure will be given.

It is expected that a low-cost application to be developed after the study will reduce the complaints of the patients, increase their quality of life and have a positive effect on women's health.

It is difficult for physicians to allocate sufficient time to convey lifestyle changes and exercises to patients with stress urinary incontinence during their busy work hours in the clinic. After the success to be achieved, the usage rate of the website to be prepared will be increased through various scientific platforms and associations.

Study Type

Interventional

Enrollment (Estimated)

100

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
      • Eskisehir, Turkey
        • Eskişehir Osmangazi Üniversitesi Tıp Fakültesi
    • Tepebaşı
      • Eskişehir, Tepebaşı, Turkey, 26000
        • Eskisehir Osmangazi University Faculty of Medicine

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

Yes

Description

Inclusion Criteria:

  • having symptoms of UI for at least the last 6 months,
  • QUID stress score is ≥ 4,
  • diagnosed with SUI as a result of the evaluation made by a specialist physician, have minimal skills in using new technologies
  • Those who have the opportunity to access the web page to be prepared can participate in the research.

Exclusion Criteria:

  • History of using medical therapy for UI,
  • existing urinary infection,
  • diabetes mellitus,
  • nervous system disease (such as multiple sclerosis, cerebrovascular disease),
  • psychiatric illness or dementia,
  • genitourinary malignancy,
  • having limited range of motion in the foot or pelvic region,
  • pregnant

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
Intervention / Treatment
No Intervention: Traditional lifestyle changes and kegel exercise recommended group
Patients with stress urinary incontinence will be given a brochure that will be prepared similar to the brochure given to the Intervention group.
Active Comparator: Group administered to individual telemedicine
A brochure containing incontinence patient information will be prepared and given, web-based training will be implemented, and informative/reminder messages will be sent via short messages every day.
Other: Group administered to individual telemedicine
A brochure containing incontinence patient information will be prepared and given, web-based training will be implemented, and informative/reminder messages will be sent via short messages every day.
Other Names:
  • Kegel and abdominal egsercises with telemedicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Telemedicine success
Time Frame: 1 year
Changes in the "frequency of incontinence episodes patients" and "adaptation to lifestyle changes (Body mass index status, smoking, exercise, fluid intake) " in the intervention and control group after the study
1 year
Quality of life score
Time Frame: 1 year
Changes in the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) score. The questionnaire includes questions such as the frequency of urinary incontinence, the amount of leakage, its impact on daily lifestyle, and in what situation the patient leaks urine. The score that can be obtained from the scale is distributed between 0-21. As the total score decreases, the quality of life increases.
1 year

Collaborators and Investigators

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

Sponsor

Eskisehir Osmangazi University

Collaborators

Eskisehir City Hospital

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)

January 1, 2023

Primary Completion (Estimated)

March 31, 2024

Study Completion (Estimated)

July 30, 2024

Study Registration Dates

First Submitted

December 9, 2023

First Submitted That Met QC Criteria

December 19, 2023

First Posted (Estimated)

January 3, 2024

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EskisehirOU/03.03.2022-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The information will not be shared as it falls under the personal data protection law.

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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