360 Degree Expanded Diaphragm Exercises in Women With Stress Urinary Incontinence

NCT06120699 | Completed

• 1 other identifier: SYY_İEÜ_2
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change of urinary symptoms

  at baseline, at 8th week

• Change of quality of life score

  at baseline, at 8th week

• Change of Pelvic floor muscle maximum voluntary contraction

  at baseline, at 8th week

• Change of maximum inspiratory pressure

  at baseline, at 8th week

• Change of maximum expiratory pressure

  at baseline, at 8th week

Study Arms (2)

360 Degree Expanded Diaphragm Exercises

EXPERIMENTAL

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

Standard Diaphragm Exercises

ACTIVE COMPARATOR

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

Interventions

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.

360 Degree Expanded Diaphragm Exercises

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.

Standard Diaphragm Exercises

Eligibility Criteria

• Age: 18 Years - 62 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Izmir University of Economics: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Izmir University of Economics

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Seda Yakıt Yeşilyurt, PhD

  Izmir University of Economics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Prof.

Model Details: This is a prospective double-blind randomized controlled study.

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 7, 2023
• Study Start: December 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: November 1, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)