The Effectiveness of a Stress Incontinence Care Protocol

Study Overview
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Brief Summary
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This study seeks to contribute to nursing practices by developing and stress incontinence care protocol with the help of the Star model and implementing this care protocol for the purpose of standardizing patient care outcomes.

Detailed Description
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To identify the effectiveness of a care protocol developed using the Star model on outcomes in female patients with stress incontinence. Information and evidence needs to be translated into nursing practice and applied to clinical decision-making in stress incontinence cases. Evidence-based study models such as the Star model provide guidance on using evidence to develop clinical guidelines and care protocols. The Star model is designed to improve patient outcomes by creating a bridge between research and clinical practice. There is currently no published stress incontinence care protocol based on the Star model. Although there is one published study of a care protocol for urinary incontinence, this protocol was not drawn up on the basis of an evidence-based model. Women that matched the sample criteria were recruited into the study. After their consent was obtained, the women were randomized into an intervention and a control group. The women in the intervention group were provided care according to stress incontinence care protocol. The control group received no intervention during the eight-week intervention period.

Official Title
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The Effectiveness of a Care Protocol Developed Using the Star Model on Female Patients With Stress Incontinence: A Randomized Controlled Trial

Conditions
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Stress Incontinence, Female, Nursing

Intervention / Treatment
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* Behavioral: intervention group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The inclusion criteria were being female, ≥ 18 years, having an initial diagnosis of SI, being literate, having no sensory disorder affecting communication, and agreeing to participate in the research Exclusion Criteria: The exclusion criteria were pregnancy, presence of a urinary tract infection and previous treatment for SI. The removal criteria were patient non-compliance with the protocol, failure in contacting the patient and the patient's wish to withdraw from the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>The intervention group received care according to the SICP (Table 2). One of the researchers gave each participant one-on-one education in line with SICP. They were also provided with the booklet that had been prepared in accordance with SICP. The participants were phoned every week for eight weeks and offered counseling within the scope of SICP and then were reevaluated at the end of eight weeks (Post-intervention). The participants were followed from the eighth to the twelfth week without any intervention (4-week post-intervention). | Behavioral: intervention group<br>* The women in the intervention group were provided care according to SICP<br>|
| No Intervention: Control group<br>The control group received no intervention during the eight-week intervention period. The control group received standard care. The women were given no educational materials. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| King's Health Questionnaire | This 32-item tool measures quality of life. Scores range from 0 - 100, with low scores indicating good quality of life. | 20 minutes | 
| Broome Pelvic Muscle Exercise Self-Efficacy Scale | This instrument was developed to measure perceived self-efficacy in pelvic floor muscle exercise. It consists of 23 items organized in two subscales. The total score ranges from 0 - 100 and scores are classified as follows: ≤ 32(low self-efficacy); 33 55 points (medium self-efficacy); ≥ 56 points (high self-efficacy). | 15 minutes | 
| Three-day voiding diary | This is a semi-objective tool used to record voiding frequency, amount of urine, amount and type of liquid intake, incontinence frequency and the frequency of pad-changing. | 3 days | 
| One-hour pad test | This test provides an objective measure of the quantity of urine leakage in a one-hour period. Before the test, the dry pad is weighed using precision scales and this weight is deducted from the wet weight to give the weight of leaked urine (Krhut et al., 2014). First the patient is given the pre-weighed pad and is then asked to drink 500 cc water and to rest in a seated position for a half-hour. In the following half- hour, the patient stands up and sits down 10 times, coughs 10 times, runs in place for 1 minute, bends to pick something up from the floor 5 times, and then climbs a flight of stairs. After one hour, the pad is taken from the patient and re-weighed on the same precision scales. The weight of the dry pad is deducted from the weight of the wet pad and the weight of urine is recorded. | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nursing, evidence-based practice, Star model, stress incontinence, nursing care protocol, female