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The Effectiveness of a Stress Incontinence Care Protocol (SICP)

Primary Purpose

Stress Incontinence, Female, Nursing

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
intervention group
Sponsored by
Kırıkkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress Incontinence, Female focused on measuring Nursing, evidence-based practice, Star model, stress incontinence, nursing care protocol, female

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention group

    Control group

    Arm Description

    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).

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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).
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 2, 2019
    Last Updated
    March 5, 2019
    Sponsor
    Kırıkkale University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03866356
    Brief Title
    The Effectiveness of a Stress Incontinence Care Protocol
    Acronym
    SICP
    Official Title
    The Effectiveness of a Care Protocol Developed Using the Star Model on Female Patients With Stress Incontinence: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1, 2016 (Actual)
    Primary Completion Date
    January 15, 2018 (Actual)
    Study Completion Date
    January 15, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kırıkkale University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stress Incontinence, Female, Nursing
    Keywords
    Nursing, evidence-based practice, Star model, stress incontinence, nursing care protocol, female

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    68 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    intervention group
    Intervention Description
    The women in the intervention group were provided care according to SICP
    Primary Outcome Measure Information:
    Title
    King's Health Questionnaire
    Description
    This 32-item tool measures quality of life. Scores range from 0 - 100, with low scores indicating good quality of life.
    Time Frame
    20 minutes
    Title
    Broome Pelvic Muscle Exercise Self-Efficacy Scale
    Description
    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).
    Time Frame
    15 minutes
    Title
    Three-day voiding diary
    Description
    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.
    Time Frame
    3 days
    Title
    One-hour pad test
    Description
    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.
    Time Frame
    1 hour

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    26209953
    Citation
    Kaya S, Akbayrak T, Toprak Celenay S, Dolgun A, Ekici G, Beksac S. Reliability and validity of the Turkish King's Health Questionnaire in women with urinary incontinence. Int Urogynecol J. 2015 Dec;26(12):1853-9. doi: 10.1007/s00192-015-2786-6. Epub 2015 Jul 26.
    Results Reference
    background
    PubMed Identifier
    23797972
    Citation
    Krhut J, Zachoval R, Smith PP, Rosier PF, Valansky L, Martan A, Zvara P. Pad weight testing in the evaluation of urinary incontinence. Neurourol Urodyn. 2014 Jun;33(5):507-10. doi: 10.1002/nau.22436. Epub 2013 Jun 24.
    Results Reference
    background
    PubMed Identifier
    23758422
    Citation
    Stevens KR. The impact of evidence-based practice in nursing and the next big ideas. Online J Issues Nurs. 2013 May 31;18(2):4.
    Results Reference
    background
    PubMed Identifier
    22882410
    Citation
    Schaffer MA, Sandau KE, Diedrick L. Evidence-based practice models for organizational change: overview and practical applications. J Adv Nurs. 2013 May;69(5):1197-209. doi: 10.1111/j.1365-2648.2012.06122.x. Epub 2012 Aug 9.
    Results Reference
    background
    PubMed Identifier
    22632069
    Citation
    Zengin N, Pinar R. Reliability and validity of the continence self-efficacy scale in Turkish women with urinary incontinence. Nurs Health Sci. 2012 Sep;14(3):277-84. doi: 10.1111/j.1442-2018.2012.00692.x. Epub 2012 May 27.
    Results Reference
    background

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    The Effectiveness of a Stress Incontinence Care Protocol

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