360 Degree Expanded Diaphragm Exercises in Women With Stress Urinary Incontinence

NCT ID: NCT06120699

Last Updated: 2024-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-11-01

Brief Summary

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.

Conditions

Stress Urinary Incontinence; Diaphragmatic Breathing; Pelvic Floor Muscle Exercise; Intra-abdominal Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Pelvic floor muscle training with 360 degree expanded diaphragm exercises

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Pelvic floor muscle training with standard diaphragm exercises

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 62 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role: collaborator

Izmir University of Economics

OTHER

Sponsor Role: lead

Responsible Party

Seda Yakit Yesilyurt

Assistant Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seda Yakıt Yeşilyurt, PhD

Role: PRINCIPAL_INVESTIGATOR

Izmir University of Economics

Locations

Izmir University of Economics

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

SYY_İEÜ_2

Identifier Type: -

Identifier Source: org_study_id