Clinical trial NCT06120699: 360 Degree Expanded Diaphragm Exercises in Women With Stress Urinary Incontinence
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Diaphragmatic Breathing
Pelvic Floor Muscle Exercise
Intra-abdominal Pressure
Lead sponsor: Izmir University of Economics
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2023-11-07
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective double-blind randomized controlled study.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change of Pelvic floor muscle contraction during Valsalva
timeFrame: at baseline, at 8th week
Secondary outcomes:
measure: Change of urinary symptoms
timeFrame: at baseline, at 8th week
measure: Change of quality of life score
timeFrame: at baseline, at 8th week
measure: Change of Pelvic floor muscle maximum voluntary contraction
timeFrame: at baseline, at 8th week
measure: Change of maximum inspiratory pressure
timeFrame: at baseline, at 8th week
measure: Change of maximum expiratory pressure
timeFrame: at baseline, at 8th week
measure: Subjective perception of improvement
timeFrame: at 8th week
measure: Change of Social Activity Participation
timeFrame: at baseline, at 8th week
measure: Change of average number of urinary incontinence
timeFrame: at baseline, at 8th week
measure: Change of Pelvic floor muscle strength
timeFrame: at baseline, at 8th week
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Izmir University of Economics
Study officials:
affiliation: Izmir University of Economics
name: Seda Yakıt Yeşilyurt, PhD
role: PRINCIPAL_INVESTIGATOR
References: