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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06120699
Enrollment
74
Registered
2023-11-07
Start date
2023-12-01
Completion date
2024-11-01
Last updated
2024-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERPelvic 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.

OTHERPelvic 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.

Sponsors

The Scientific and Technological Research Council of Turkey
CollaboratorOTHER
Izmir University of Economics
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

This is a prospective double-blind randomized controlled study.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 62 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change of Pelvic floor muscle contraction during Valsalvaat baseline, at 8th weekPelvic 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.

Secondary

MeasureTime frameDescription
Change of quality of life scoreat baseline, at 8th weekUrinary incontinence symptoms and their impact on quality of life will be evaluated with the International Urinary Incontinence Questionnaire Form.
Change of Pelvic floor muscle maximum voluntary contractionat baseline, at 8th weekMaximum 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 (%).
Change of maximum inspiratory pressureat baseline, at 8th weekA non-invasive, RP Check brand electronic pressure measuring device (MD Diagnostics Ltd., Maidstone, UK) will be used to measure maximum inspiratory pressure.
Change of maximum expiratory pressureat baseline, at 8th weekA non-invasive, RP Check brand electronic pressure measuring device (MD Diagnostics Ltd., Maidstone, UK) will be used to measure maximum expiratory pressure.
Change of urinary symptomsat baseline, at 8th weekThe severity of women's incontinence will be questioned with the Incontinence Severity Index.
Change of Social Activity Participationat baseline, at 8th weekThe 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.
Change of average number of urinary incontinenceat baseline, at 8th weekWomen will be asked to complete a bladder diary reflecting the daily activity patterns of the bladder for 3 consecutive days.
Change of Pelvic floor muscle strengthat baseline, at 8th weekVaginal palpation method will be used to measure pelvic floor muscle strength. (Modified Oxford Scale)
Subjective perception of improvementat 8th weekWomen's subjective perception of improvement was assessed using the Global Perception of Improvement scale

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026