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

E

Eskisehir Osmangazi University

Status

Invitation-only

Conditions

Stress Urinary Incontinence

Treatments

Other: Group administered to individual telemedicine

Study type

Interventional

Funder types

Other

Identifiers

NCT06189443
EskisehirOU/03.03.2022-20

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

Female

Ages

20 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups

Traditional lifestyle changes and kegel exercise recommended group
No Intervention group
Description:
Patients with stress urinary incontinence will be given a brochure that will be prepared similar to the brochure given to the Intervention group.
Group administered to individual telemedicine
Active Comparator group
Description:
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.
Treatment:
Other: Group administered to individual telemedicine

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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