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Clinical Trials/NCT06120699
NCT06120699
Completed
Not Applicable

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

Izmir University of Economics1 site in 1 country74 target enrollmentDecember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress Urinary Incontinence
Sponsor
Izmir University of Economics
Enrollment
74
Locations
1
Primary Endpoint
Change of Pelvic floor muscle contraction during Valsalva
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2023
End Date
November 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Izmir University of Economics
Responsible Party
Principal Investigator
Principal Investigator

Seda Yakit Yesilyurt

Assistant Prof.

Izmir University of Economics

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.

Outcomes

Primary Outcomes

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

  • Change of quality of life score(at baseline, at 8th week)
  • Change of urinary symptoms(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)
  • Subjective perception of improvement(at 8th week)
  • Change of Social Activity Participation(at baseline, at 8th week)
  • Change of Pelvic floor muscle strength(at baseline, at 8th week)
  • Change of average number of urinary incontinence(at baseline, at 8th week)

Study Sites (1)

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