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

NCT ID: NCT06189443

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-07-30

Brief Summary

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.

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.

Conditions

Stress Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Group administered to individual telemedicine

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Kegel and abdominal egsercises with telemedicine

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eskisehir City Hospital

OTHER

Sponsor Role: collaborator

Eskisehir Osmangazi University

OTHER

Sponsor Role: lead

Responsible Party

SEVDA SUNGUR

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Eskisehir Osmangazi University Faculty of Medicine

Eskişehir, Tepebaşı, Turkey (Türkiye)

Eskişehir Osmangazi Üniversitesi Tıp Fakültesi

Eskişehir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Schroeder M, Plotner EA, Sharma S, Hunter K, Spector S, Lipetskaia L. A Randomized Controlled Trial of a Multimedia Patient Education Tool for Stress Versus Urgency Urinary Incontinence. Female Pelvic Med Reconstr Surg. 2021 Jul 1;27(7):403-408. doi: 10.1097/SPV.0000000000000946.

Reference Type: BACKGROUND

PMID: 32925421 (View on PubMed)

Rygh P, Asklund I, Samuelsson E. Real-world effectiveness of app-based treatment for urinary incontinence: a cohort study. BMJ Open. 2021 Jan 4;11(1):e040819. doi: 10.1136/bmjopen-2020-040819.

Reference Type: BACKGROUND

PMID: 33397664 (View on PubMed)

Other Identifiers

EskisehirOU/03.03.2022-20

Identifier Type: -

Identifier Source: org_study_id