Kegel and Abdominal Exercises on Urinary Incontinence Severity, Quality of Life, and Sleep Quality in Menopausal Women

NCT06096818 | Completed

• 1 other identifier: B.30.2.ODM.0.20/60-164
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomized, controlled experimental study is to investigate the effectiveness of Kegel exercises and abdominal exercises on urinary incontinence severity, quality of life, and sleep quality in menopausal women with stress urinary incontinence. Research Hypothesis are: H1: Combining Kegel exercises and abdominal exercises affects urinary incontinence severity in menopausal women with stress urinary incontinence. H2: Combining kegel exercises and abdominal exercises affects quality of life in menopausal women with stress urinary incontinence. H3: Combining kegel exercises and abdominal exercises affects sleep quality in menopausal women with stress urinary incontinence. Researchers will compare two groups: Kegel and abdominal exercise training is applied to the experimental group. Only kegel exercise training is applied to the control group. The study will be conducted in a prospective, randomized, parallel group controlled design. Hypotheses will be evaluated by applying pre-test and post-tests to the groups of exercises applied for three months during the research process.

Conditions

Urinary Incontinence; Postmenopausal Symptoms; Sleep Quality

Keywords

Menopause; Female; Urinary incontinence; Kegel Exercise; Abdomen Exercise

Outcome Measures

Primary Outcomes (3)

• Urinary Incontinence Severity

  70 women as assessed by International Consultation on Incontinence Questionnaire-Short Form, Change From Baseline in Urinary Incontinence Severity at 3 months. In menopausal women with urinary incontinence, performing kegel exercises and abdominal exercises together reduces the total score of the International Consultation on Incontinence Questionnaire-Short Form. The International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) consisting of 6 questions was used to assess the severity, frequency, type of incontinence and its implications on quality of life. The possible scores on the scale are between 0 and 21.

  The change in the International Consultation on Incontinence Questionnaire-Short Form score of the participants in 3 months was evaluated.

• Quality of life of women with urinary incontinence will be evaluated

  Incontinence Impact Questionnaire (IIQ-7): This scale is reliable, consistent and valid instrument to measure of the impact of urinary incontinence, to assess the impact on quality of life in Turkish speaking women with urinary incontinence. The Likert-type scale has four dimensions: physical activity, travel, social relations and emotional health. A minimum of 0 and a maximum of 21 points can be obtained from IIQ-7. The total score and sub-dimension scores of the form are calculated on a scale of 0 - 100 points. Low scores obtained from each IIQ-7 are an indicator of increased quality of life.

  The change in the incontinence Impact Questionnaire-IIQ-7 score of the participants in 3 months was evaluated. Participants were expected to have an decrease in their scores during this time

• Sleep Quality

  Pittsburgh Sleep Quality Scale (PSQI): It is a scale to evaluate sleep quality with questions asked under seven main headings that evaluate subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disorders, use of sleeping pills and impairment in daytime functions. The total score of the scale is between 0-21. If the total score is 5 or above, sleep quality is considered poor. High scores indicate poor sleep quality.

  The change in the participants' sleep quality at 3 months was evaluated with The Pittsburgh Sleep Quality Scale. Participants were expected to have an decrease in their scores during this time.

Study Arms (2)

Experimental Group: Kegel exercises and abdominal exercises

EXPERIMENTAL

Kegel exercises and abdominal exercises training has given to this group

Behavioral: Experimental Group: Kegel exercises and abdominal exercises; Behavioral: Control Group: Kegel exercises

Control Group: Kegel exercises

NO INTERVENTION

Kegel exercises exercises training has given to this group

Interventions

Experimental Group: Kegel exercises and abdominal exercises BEHAVIORAL

The training was planned to occur 3 times in a 12-week period (first meeting+6thweek+12th week). Each training: approx. 30 min. First session:Meeting the woman Consent and data collection forms (Descriptive characteristics of women, Incontinence Impact Questionnaire-Short Form,International Urinary Incontinence Consultation Questionnaire-Short Form,Pittsburgh Sleep Quality Scale) Information about stress urinary incontinence is given The woman is given kegel exercise and abdominal exercise training face to face by the researchers. Kegel and abdominal exercise application chart is explained and given as homework. Relevant brochure is provided. Second Session:Greeting-Kegel and abdominal exercise application chart is being checked Kegel and abdominal exercises are performed again under the supervision of the researcher. Third session:Greeting-Kegel and abdominal exercise application chart is being checked Data collection tools are being refilled.

Experimental Group: Kegel exercises and abdominal exercises

Control Group: Kegel exercises BEHAVIORAL

The training was planned to occur 3 times in a 12-week period (first meeting+6th week+12th week). Each training: approx. 20 min. First session: Meeting the woman Consent and data collection forms (Descriptive characteristics of women, Incontinence Impact Questionnaire-Short Form, International Urinary Incontinence Consultation Questionnaire-Short Form, Pittsburgh Sleep Quality Scale). Information about stress urinary incontinence is given The woman is given kegel exercise training face to face by the researchers. Kegel exercise application chart is explained and given as homework. Relevant brochure is provided. Second Session:Greeting-Kegel exercise application chart is being checked Kegel exercises are performed again under the supervision of the researcher. Third session:Greeting-Kegel exercise application chart is being checked Data collection tools are being refilled.

Experimental Group: Kegel exercises and abdominal exercises

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Criteria for inclusion in the study: * Able to read and write, * Without hearing difficulty or vision loss, Able to communicate, * Those who have not received any treatment for incontinence, * Having a body mass index (BMI) \< 30, * Those who have stage 0-I-II stress urinary incontinence complaints, who have been diagnosed with stress incontinence by a physician and who do not require surgical treatment for stress incontinence, * Women in menopause who agree to participate in the study will be included in the study. Criteria for exclusion from the study: * Having diabetes, * Those who use diuretics and antihypertensive drugs, * Having a urinary system infection, * Those with pelvic organ prolapse, * Having undergone incontinence surgery, * Those with lumbar disc herniation, * Body mass index (BMI) \> 30, * Those who have stage III-IV stress urinary incontinence complaints, have been diagnosed and require surgical treatment for stress incontinence * Women who do not agree to participate in the study and who are not in menopause will not be included in the study.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead
• Ondokuz Mayıs University: collaborator

Study Sites (1)

Istanbul University - Cerrahpaşa

Istanbul, Marmara Region, 34325, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant, Investigator) Women who meet the inclusion criteria were included in the sample using a simple random method. Before the research numbers were produced from random.org, envelopes of the same size and characteristics were created for each participant by someone other than the researcher (IU-C, Research Assistant B.Y), and numbers between 1 and 100 were written on them. Then, considering the data losses, numbers from 1 to 100 were generated from random.org. Single-column groups were created between 1 and 100 by the help of the Random Integer Generator at the Numbers title of the Random.org website. The numbers (1 or 2) were assigned to the groups (study and control) randomly by tossing a coin. Number 1 was assigned to the control group, and number 2 to the experimental group. Experimental Group: 35 women Control Group: 35 women
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Parallel Assignment Type of Study: This study is a randomized controlled trial. The pre-test-post-test has be carried out with a pattern.

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 24, 2023
• Study Start: May 1, 2023
• Primary Completion: November 15, 2023
• Study Completion: November 20, 2023
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)