Clinical trial NCT06189443: Abdominal-Kegel Exercise and the Effect of Telemedicine in Stress Urinary Incontinence
Official title: Abdominal-Kegel Exercise in Patients With Stress Urinary Incontinence and the Effect of Telemedicine Applications on Adaptation to Lifestyle Changes: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: stress urinary incontinence
Kegel exercises
Randomization
Telemedicine
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
Collaborators: name: Eskisehir City Hospital
First posted: 2024-01-03
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Telemedicine success
timeFrame: 1 year
measure: Quality of life score
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Eskişehir
country: Turkey
facility: Eskisehir Osmangazi University Faculty of Medicine
state: Tepebaşı
city: Eskisehir
country: Turkey
facility: Eskişehir Osmangazi Üniversitesi Tıp Fakültesi
Study officials:
References:
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.
citation: 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.