Pelvic Floor Muscle Exercises and Core Exercises in Menopausal Women

NCT06348342 | Completed DMC

• 1 other identifier: TÜTF-GOBAEK 2023/24
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

The prospective and four-arm randomized controlled study was conducted on n = 136 (34 = control, 34 = kegel, 34 = core, 34 = kegel+ core group) menopausal women at Trakya University Health Research and Application Center Urology Polyclinic between Oct 2023 and June 2024. In the first interview, the researcher will apply an information form to all four groups, asking about personal information, habits, bladder irritants and fluid intake-related features, obstetric, gynecological and systemic disease-related features, and stress urinary incontinence-related features. This form will only be filled at the beginning. In addition, the \"Pelvic Floor Distress Scale (PFDI)\" and \"Pelvic Floor Impact Questionnaire (PFIQ)\" will be applied and will be repeated by the executive researcher at the 1st, 2nd and 3rd controls. It will be terminated at the 3rd follow-up. Descriptive statistics, Pearson, Spearman\'s correlation, and regression analyzes will be used in the analysis of research data.

Conditions

Menopause; Stress Urinary Incontinence; Kegel Exercises; Core Strength

Outcome Measures

Primary Outcomes (2)

• Pelvic floor evaluated using the Pelvic Floor Distress Inventory (PFDI - Pelvic Floor Distress Inventionary)

  PFDI is a symptom questionnaire consisting of 20 items used to measure the degree of discomfort caused by pelvic symptoms in women. Each item consists of 4 options (Not at all, Rarely, Moderately, Quite a lot) and is given a score between 1 and 4. PFDI consists of 3 subscales.

  change from baseline and 1, 2, and 3 months of practice

• Pelvic floor impact evaluated using the Pelvic Floor Impact Questionnaire (PFIQ Pelvic Floor Impact Questionnaire)

  PFIQ is a pelvic floor quality of life questionnaire used to evaluate the effects of bowel, bladder and/or pelvic symptoms on the individual's daily living activities, social relationships and emotions. Each item consists of 4 options (Not at all, Rarely, Moderately, Quite a lot) and is given a score between 0 and 3. The PFIQ scale also consists of 3 subscales.

  change from baseline and 1, 2, and 3 months of practice

Secondary Outcomes (4)

• Urinary incontinence evaluated using the Stress Test

  change from baseline and 1, 2, and 3 months of practice

• Urinary incontinence evaluated using the Uroflowmetry

  change from baseline and 1, 2, and 3 months of practice

• Urinary incontinence evaluated using the Pelvic Floor Muscle Strength Measurement

  change from baseline and 1, 2, and 3 months of practice

• Urinary incontinence evaluated using the Digital Palpation

  change from baseline and 1, 2, and 3 months of practice

Study Arms (4)

Control

NO INTERVENTION

Kegel

EXPERIMENTAL

Kegel exercises

Other: Pelvic Floor Muscle Exercise

Core

EXPERIMENTAL

Core exercises

Other: Core Exercise

Kegel+core

EXPERIMENTAL

Kegel and core exercises

Other: Pelvic Floor Muscle Exercise; Other: Core Exercise

Interventions

Pelvic Floor Muscle Exercise OTHER

Training for PFME will be given orally and will cover the importance of FME and how to do the exercises, as well as the conditions and frequency of doing the exercises. You will be told that the exercise should be done when the bladder is empty, three times a day (morning, noon and evening) and repeated 10 times in each set. In the first week of exercise, the pelvic floor muscles will be contracted for 3 seconds and relaxed for 3 seconds, and will be increased by 1 second each week. It will be explained that from the 8th week onwards, it will be done by contracting for 10 seconds and relaxing for 10 seconds and will continue. It will be stated that the learning process of pelvic floor muscle exercise may take 6 weeks to 6 months. It will be stated that this exercise should be applied throughout their lives for the sustainability of PFM strength. The training is planned to last approximately 20 minutes. PFME will last for two months. Women in menopause will be given an exercise chart.

Kegel; Kegel+core

Core Exercise OTHER

Activating the contraction of the deep core muscles TrA and mutifidus without disrupting breathing forms the basis of core stabilization exercises. To teach the \"abdominal hallowing\" maneuver, which enables the activation of these muscles, patients will be shown a picture of the TrA muscle and asked to contract their lower abdominal muscles while lying on their back in the hook position. During the maneuver, care will be taken to ensure that no movement occurs in the trunk and pelvis and that diaphragmatic breathing continues. After the abdominal hallowing maneuver is taught, the exercises will be progressed gradually. A home exercise program will be given for this. The 7-level exercise program recommended by Hagins et al. will be used as a home exercise program. The movements in this program load more moments on the muscles that stabilize the lumbar spine as the levels progress. The stages of the exercise program are shared in the brochure to be given to the patients.

Core; Kegel+core

Eligibility Criteria

• Age: 45 Years+
• Gender Eligibility Details: It is gender-focused because it is carried out specifically for the menopause period.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteer to participate in the study,
• Those over the age of 45 who are in menopause,
• Women with coitus (+),
• Body mass index \< 30 kg/m2,
• Not addicted to alcohol or drugs,
• Experiences recorded unintentional leakage more than once a week,
• Those diagnosed with Stage I-II stress urinary incontinence complaints, Patients whose stress incontinence does not require surgical or medical treatment will be included in the study.

You may not qualify if:

• Those who do not volunteer to participate in the study,
• Women who are under the age of 45 and are not in menopause,
• Women with (-) coitus,
• Having a pacemaker installed,
• Presence of a device implanted in the pelvis or hip joint(s),
• Having had pelvic or abdominal surgery in the last 6 months,
• Having a neurological or psychiatric disease,
• Having a urinary tract infection,
• Body mass index \>30 kg/m2,
• Those who are addicted to alcohol or drugs,
• Not experiencing any recorded unintentional leakage events more than once a week,
• Those diagnosed with Stage III-IV Stress urinary incontinence complaints,
• Patients requiring surgical and medical treatment of stress incontinence will not be included in the study.

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Bartın University

Bartın, 78100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof

Model Details: Before starting the research, four groups of mothers will be randomly formed. As a randomization method, mothers who meet the sampling inclusion criteria determined in the research will be identified and listed. Individuals to be taken into two groups will be determined by randomization method from the random numbers table. (http://www.stattrek.com/statistics/randomnumbergenerator.aspx).

Study Record Dates

• First Submitted: March 30, 2024
• First Posted: April 4, 2024
• Study Start: October 15, 2023
• Primary Completion: April 20, 2024
• Study Completion: September 30, 2024
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)