Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06189443
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-01-03
First Post:
2023-12-09
Brief Title:
Abdominal-Kegel Exercise and the Effect of Telemedicine in Stress Urinary Incontinence
Sponsor:
Eskisehir Osmangazi University
Organization:
Eskisehir Osmangazi University
Study Overview
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
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 05 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 womens 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
When type 1 α error was 5 type 2 error 1-β was 95 and the effect size was accepted as 05 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 womens 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None