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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06189443
Other study ID # EskisehirOU/03.03.2022-20
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date July 30, 2024

Study information

Verified date December 2023
Source Eskisehir Osmangazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 100
Est. completion date July 30, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 65 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Turkey Eskisehir Osmangazi Üniversitesi Tip Fakültesi Eskisehir
Turkey Eskisehir Osmangazi University Faculty of Medicine Eskisehir Tepebasi

Sponsors (2)

Lead Sponsor Collaborator
Eskisehir Osmangazi University Eskisehir City Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Telemedicine success 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
Primary Quality of life score 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
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