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Completed

NCT Number: NCT03866356

The Effectiveness of a Stress Incontinence Care Protocol

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.

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Key information

Conditions

Stress Incontinence, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Nursing Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intervention Group

Behavioral

The women in the intervention group were provided care according to SICP

Primary outcomes

  1. King's Health Questionnaire

    Time frame: 20 minutes

    This 32-item tool measures quality of life. Scores range from 0 - 100, with low scores indicating good quality of life.

  2. Broome Pelvic Muscle Exercise Self-Efficacy Scale

    Time frame: 15 minutes

    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).

  3. Three-day voiding diary

    Time frame: 3 days

    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.

  4. One-hour pad test

    Time frame: 1 hour

    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.

Sponsors and collaborators

Lead sponsor

Kırıkkale University

Other

Registry information

Official study title

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

Acronym: SICP

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 7, 2019
Registry last updated
Mar 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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