360 Degree Expanded Diaphragm Exercises in Women With Stress Urinary Incontinence

Effectiveness of Pelvic Floor Muscle Training Including 360 Degree Expanded Diaphragm Exercises in Women With Stress Urinary Incontinence: Double-Blind Randomized Controlled Study

This study was planned to examine and compare the effects of standard diaphragm exercises with Pelvic floor muscle exercises (PFME) and 360-degree expanded diaphragm exercises with PFME on urinary symptoms, PFM functions and quality of life in women with stress urinary incontinence.

Study Overview

• Status: Recruiting
• Conditions: Stress Urinary Incontinence; Diaphragmatic Breathing; Pelvic Floor Muscle Exercise; Intra-abdominal Pressure
• Intervention / Treatment: Other: Pelvic floor muscle training with 360 degree expanded diaphragm exercises; Other: Pelvic floor muscle training with standard diaphragm exercises

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Seda Yakıt Yeşilyurt, PhD; Phone Number: 05302662522; Email: sedayakit01@gmail.com
• Study Contact Backup: Name: Gonca Şahiner Pıcak; Phone Number: 05058081268; Email: gonca.sahiner@ieü.edu.tr

Study Locations

• Turkey
  • İzmir, Turkey
    • Recruiting
    • Izmir University of Economics
    • Contact: Gonca Şahiner Pıcak; Phone Number: 05058081268; Email: gonca.sahiner@ieü.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Being a woman,
• Participating in the research voluntarily,
• Being between the ages of 18-62,
• Ability to read and write Turkish,
• Not having any mental problems that would prevent cooperation and understanding,
• Having a complaint of stress urinary incontinence or stress-predominant mixed urinary incontinence.

Exclusion Criteria:

• Having received pelvic floor training before,
• Having a neurological disease,
• Pelvic organ prolapse stage is stage 2 or higher,
• Having fecal incontinence,
• Being pregnant,
• Lower extremity problems that may affect the pelvic structure (conditions such as lower extremity inequality, total hip arthroplasty)
• Having an active lower urinary tract infection,
• Having respiratory system diseases such as chronic obstructive pulmonary disease and asthma,
• Having undergone hysterectomy surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 360 Degree Expanded Diaphragm Exercises; Volunteers who complain of urinary incontinence in situations such as coughing, sneezing and laughing, who have been diagnosed with stress or stress-predominant mixed urinary incontinence by a Gynecology and Obstetrics physician, and who meet the inclusion criteria will be included in the study.	Other: Pelvic floor muscle training with 360 degree expanded diaphragm exercises; Women in this group will be taught 360-degree expanded diaphragm exercises with the Ohmbelt device. Two Ohmbelt devices will be used in this study. The anterior sensor will be placed in the inguinal cavity to visualize the expansion of the anterior abdominal wall, and the posterior sensor will be placed contralaterally in the upper lumbar triangle to visualize the expansion of the posterior wall. The protocol of breathing exercises is inspiration and expiration time of 6 seconds, 10 repetitions and 3 sets. Pelvic floor muscle training will be given with the NeuroTract Myoplus 4 PRO EMG biofeedback device. The training protocol: Each patient will be asked to contract close to the maximum pelvic floor muscle contraction for slow muscle contraction, maintain the contraction for 6-8 seconds, and then perform fast muscle contractions 3-4 times. This cycle is 1 set, 8-12 repetitions. A total of 3 sets will be applied.
Active Comparator: Standard Diaphragm Exercises; Volunteers who complain of urinary incontinence in situations such as coughing, sneezing and laughing, who have been diagnosed with stress or stress-predominant mixed urinary incontinence by a Gynecology and Obstetrics physician, and who meet the inclusion criteria will be included in the study.	Other: Pelvic floor muscle training with standard diaphragm exercises; Women in this group will be taught standard diaphragm exercises. In the supine position, with the head and knees supported by a pillow, the patient will first be asked to close his or her eyes to focus. With one hand on the chest and the other hand on the abdomen, "Take a deep breath through your nose and direct all the air as much as possible under your lower hand. inflate your belly. Now exhale all the air slowly through your mouth." The protocol of breathing exercises is inspiration and expiration time of 6 seconds, 10 repetitions and 3 sets. Pelvic floor muscle training will be given with the NeuroTract Myoplus 4 PRO EMG biofeedback device. The training protocol: Each patient will be asked to contract close to the maximum pelvic floor muscle contraction for slow muscle contraction, maintain the contraction for 6-8 seconds, and then perform fast muscle contractions 3-4 times. This cycle is 1 set, 8-12 repetitions. A total of 3 sets will be applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Pelvic floor muscle contraction during Valsalva	Pelvic floor muscle contraction during Valsalva will be evaluated with the NeuroTract Myoplus 4 PRO EMG device. A disposable, cylindrical endovaginal probe will be used to record pelvic floor muscle electromyographic activity. The evaluation will be carried out as stated in previous studies, and the women are told: "Take as deep a breath as possible, pinch your nose with your thumb and index finger and close your mouth, try to breathe out against the now closed respiratory system." instructions will be given. For a clearer understanding, the expression "pretend to strain" will also be used. The probe will be manually supported by the investigator throughout the testing procedure to prevent the pressure probe from moving and losing contact with the PTK during evaluation. 2 seconds of reflex PFM activity will be recorded in μV.	at baseline, at 8th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of urinary symptoms	The severity of women's incontinence will be questioned with the Incontinence Severity Index.	at baseline, at 8th week
Change of quality of life score	Urinary incontinence symptoms and their impact on quality of life will be evaluated with the International Urinary Incontinence Questionnaire Form.	at baseline, at 8th week
Change of Pelvic floor muscle maximum voluntary contraction	Maximum voluntary contraction of women will be evaluated with the NeuroTract Myoplus 4 PRO EMG device. A disposable, cylindrical endovaginal probe will be used to record pelvic floor muscle electromyographic activity. MVC, average peak activation results during three PFM contractions will be expressed in μV and percentage (%).	at baseline, at 8th week
Change of maximum inspiratory pressure	A non-invasive, RP Check brand electronic pressure measuring device (MD Diagnostics Ltd., Maidstone, UK) will be used to measure maximum inspiratory pressure.	at baseline, at 8th week
Change of maximum expiratory pressure	A non-invasive, RP Check brand electronic pressure measuring device (MD Diagnostics Ltd., Maidstone, UK) will be used to measure maximum expiratory pressure.	at baseline, at 8th week
Subjective perception of improvement	Women's subjective perception of improvement was assessed using the Global Perception of Improvement scale	at 8th week
Change of Social Activity Participation	The Social Activity Index will be used, in which nine social situations are selected to represent situations in which women have problems in social participation due to urinary incontinence.	at baseline, at 8th week
Change of average number of urinary incontinence	Women will be asked to complete a bladder diary reflecting the daily activity patterns of the bladder for 3 consecutive days.	at baseline, at 8th week
Change of Pelvic floor muscle strength	Vaginal palpation method will be used to measure pelvic floor muscle strength. (Modified Oxford Scale)	at baseline, at 8th week

Collaborators and Investigators

• Sponsor: Izmir University of Economics
• Investigators: Principal Investigator: Seda Yakıt Yeşilyurt, PhD, Izmir University of Economics

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 1, 2023
• First Submitted That Met QC Criteria: November 1, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 3, 2024
• Last Verified: February 1, 2024

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; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: SYY_İEÜ_2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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