The Effectiveness of a Stress Incontinence Care Protocol (SICP)

March 5, 2019 updated by: Emel Gülnar, Kırıkkale University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
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
The women in the intervention group were provided care according to SICP
No Intervention: Control group
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
20 minutes
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).
15 minutes
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.
3 days
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.
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kırıkkale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

January 15, 2018

Study Completion (Actual)

January 15, 2018

Study Registration Dates

First Submitted

March 2, 2019

First Submitted That Met QC Criteria

March 5, 2019

First Posted (Actual)

March 7, 2019

Study Record Updates

Last Update Posted (Actual)

March 7, 2019

Last Update Submitted That Met QC Criteria

March 5, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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