360 Degree Expanded Diaphragm Exercises in Women With Stress Urinary Incontinence

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06120699
• Other study ID #: SYY_IEÜ_2
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: February 2024
• Source: Izmir University of Economics
• Contact: Gonca Sahiner Piçak
• Phone: 05058081268
• Email: gonca.sahiner[@]ieü.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: December 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 62 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diaphragmatic Breathing
• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Izmir University of Economics	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Izmir University of Economics

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change of urinary symptoms	The severity of women's incontinence will be questioned with the Incontinence Severity Index.	at baseline, at 8th week
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Subjective perception of improvement	Women's subjective perception of improvement was assessed using the Global Perception of Improvement scale	at 8th week
Secondary	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
Secondary	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
Secondary	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