The Effectiveness of a Stress Incontinence Care Protocol

Nursing Clinical Trial

— SICP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03866356
• Other study ID #: KU
• Status: Completed
• Phase: N/A
• Start date: December 1, 2016
• Est. completion date: January 15, 2018

Study information

• Verified date: March 2019
• Source: Kirikkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: January 15, 2018
• Est. primary completion date: January 15, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nursing
• Stress Incontinence, Female
• Urinary Incontinence, Stress

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kirikkale University

References & Publications (5)

Kaya S, Akbayrak T, Toprak Çelenay S, Dolgun A, Ekici G, Beksaç 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. — View Citation

Krhut J, Zachoval R, Smith PP, Rosier PF, Valanský 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. Review. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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