Effects of Pelvic Floor Health Education Program in Women With Stress Urinary Incontinence

The aim of this study is to investigate the effects of pelvic floor health education program on urinary incontinence symptoms, knowledge level and quality of life in women with stress urinary incontinence.

Study Overview

• Status: Not yet recruiting
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Other: Education and booklet; Other: Booklet

Detailed Description

Stress urinary incontinence (SUI) is the involuntary urinary incontinence that develops in parallel with the increase in intra-abdominal pressure and is seen in the absence of detrusor contraction. Studies have shown that SUI, leading to a decrease in the quality of life and worsening of social and health conditions, is more common in women than men.

Knowledge of pelvic floor health or urinary incontinence is generally low. Low level of knowledge or wrong information limits patients' access to treatment. Pelvic floor muscle exercise and lifestyle recommendations are also the first treatment options for SUI.

The information and awareness related to the pelvic floor and SUI can be increase and unhealthy behavioral strategies can be modifiable through education programs. Therefore the education programs related to the pelvic floor health would have positive effects on urinary incontinence symptoms, knowledge level and quality of life. Studies about this issue are needed.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Participation Criteria

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:

• Being between the ages of 18-65
• Women with stress urinary incontinence
• Those who volunteered to participate in the study
• Being literate

Exclusion Criteria:

• Having advanced pelvic organ prolapse
• Having a malignancy
• Having a urinary tract infection
• Those who have a problem that interferes with cooperation and understanding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Education group; The education program was given both an educational presentation and a booklet related to the pelvic floor health	Other: Education and booklet; The education program was given both an educational presentation accompanied by a physiotherapist once a week for six weeks and a booklet related to the pelvic floor health (pelvic floor, urinary incontinence, risk factors, treatment options, healthy behavioral strategies etc.)
OTHER: Control group; The control group will be given a booklet related to the pelvic floor health	Other: Booklet; The control group will be given a booklet related to the pelvic floor health (pelvic floor, urinary incontinence, risk factors, treatment options, healthy behavioral strategies etc.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of urinary incontinence symptoms	International Consultation on Incontinence Questionnaire-Short Form will be used to evaluate the urinary incontinence symptoms. The scale has 6 questions and 4 dimensions (frequency, severity, type of urinary incontinence, and its effect on daily life). The score to be obtained from the scale varies between "0" and "21". As the score increases, the urinary incontinence symptoms also increases.	change from baseline at 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic floor health knowledge level	Pelvic Floor Health Knowledge Quiz will be used to evaluate the knowledge level of patients about general pelvic floor health. It consists of 3 subscales (function/dysfunction, risk/etiology subscale and diagnosing/treatment) and total 29 questions. Total score is calculated by summing the number of correct responses, which range between 0 and 29, where a higher score indicates a higher level of knowledge about the pelvic floor health	change from baseline at 6 weeks
Urinary incontinence konwledge level	The Prolapse Incontinence Knowledge Quiz-urinary incontinence subscale will be used to evaluate the knowledge level of the urinary incontinence. It consists of 12 items. Total score is calculated by summing the number of correct responses, which range between 0 and 12, where a higher score indicates a higher level of knowledge about urinary incontinence.	change from baseline at 6 weeks
Life quality	King Health Questionnaire will be used to evaluate the life quality. The questionnaire, consisting of thirty-two items, consists of 2 parts. In the first part, there are 2 questions questioning the general health perception and incontinence effect, and 19 questions dividing the quality of life into 7 areas (role limitations, physical limitations, social limitations, personal relationships, emotional problems, sleep/energy disorders, symptom severity measurement). In the second part, there are 11-item complaint severity scales that evaluate the presence and severity of urinary symptoms. While the best score that can be obtained on the complaint severity scale is "0", the worst score is "30", the best score that can be obtained for all King Health Questionnaire subsections is "0" and the worst score is "100".	change from baseline at 6 weeks
Compliance with the program	Compliance with the program will be evaluated using a 10-cm visual analog scale. 0 point indicates "did not comply with the program" and 10 point indicates " complied with the program".	after program (6th week)

Collaborators and Investigators

• Sponsor: Ankara Yildirim Beyazıt University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 15, 2022
• Primary Completion (ANTICIPATED): October 15, 2022
• Study Completion (ANTICIPATED): July 15, 2023

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (ACTUAL): June 29, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 29, 2022
• Last Update Submitted That Met QC Criteria: June 27, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: 2022/06/27

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No