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Completed

NCT Number: NCT06120699

360 Degree Expanded Diaphragm Exercises in Women With Stress Urinary Incontinence

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.

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Key information

Conditions

Stress Urinary Incontinence Diaphragmatic Breathing Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Intra-abdominal Pressure Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Pelvic Floor Muscle Exercise Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–62 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Izmir University of Economics

Izmir, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pelvic floor muscle training with 360 degree expanded diaphragm exercises

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.

Pelvic floor muscle training with standard diaphragm exercises

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.

Primary outcomes

  1. Change of Pelvic floor muscle contraction during Valsalva

    Time frame: at baseline, at 8th week

    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.

Secondary outcomes

  1. Change of urinary symptoms

    Time frame: at baseline, at 8th week

    The severity of women's incontinence will be questioned with the Incontinence Severity Index.

  2. Change of quality of life score

    Time frame: at baseline, at 8th week

    Urinary incontinence symptoms and their impact on quality of life will be evaluated with the International Urinary Incontinence Questionnaire Form.

  3. Change of Pelvic floor muscle maximum voluntary contraction

    Time frame: at baseline, at 8th week

    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 (%).

  4. Change of maximum inspiratory pressure

    Time frame: at baseline, at 8th week

    A non-invasive, RP Check brand electronic pressure measuring device (MD Diagnostics Ltd., Maidstone, UK) will be used to measure maximum inspiratory pressure.

  5. Change of maximum expiratory pressure

    Time frame: at baseline, at 8th week

    A non-invasive, RP Check brand electronic pressure measuring device (MD Diagnostics Ltd., Maidstone, UK) will be used to measure maximum expiratory pressure.

  6. Subjective perception of improvement

    Time frame: at 8th week

    Women's subjective perception of improvement was assessed using the Global Perception of Improvement scale

  7. Change of Social Activity Participation

    Time frame: at baseline, at 8th week

    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.

  8. Change of average number of urinary incontinence

    Time frame: at baseline, at 8th week

    Women will be asked to complete a bladder diary reflecting the daily activity patterns of the bladder for 3 consecutive days.

  9. Change of Pelvic floor muscle strength

    Time frame: at baseline, at 8th week

    Vaginal palpation method will be used to measure pelvic floor muscle strength. (Modified Oxford Scale)

Sponsors and collaborators

Lead sponsor

Izmir University of Economics

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 7, 2023
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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