Clinical trial NCT04991675: Diaphragmatic Breathing Exercises on Urinary Incontinence
Official title: The Role of Diaphragmatic Breathing Exercise on Urinary Incontinence Treatment: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Keywords: Diaphragmatic breathing exercise
Pelvic floor muscles exercises
Kegel exercise
Urinary incontinence
Physiotherapy
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 40
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomized into two groups: pelvic floor muscle exercises (Group PFM n=20) and diaphragmatic breathing exercises (Group DB n=20). Exercise programs consisted of 1 set of contractions per day and each set included 30 repetitions for 6 weeks. Women were asked to complete forms of Incontinence Impact Questionnaire (IIQ-7) and the Urogenital Distress Inventory (UDI-6), Incontinence Quality of Life (I-QOL), and Overactive Bladder (OAB-V3) before starting the program and again at the end of the 6-week program. Changes from baseline were compared in both groups and between the two groups.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main aim of this pilot study was to examine the effect of diaphragmatic breathing exercise on urinary incontinence treatment. The secondary purpose was to compare the effect of pelvic floor muscle exercises and diaphragmatic breathing exercises on urinary incontinence women.

Design: Participants were randomized into two groups: pelvic floor muscle exercises (Group PFM n=20) and diaphragmatic breathing exercises (Group DB n=20). Exercise programs consisted of 1 set of contractions per day and each set included 30 repetitions for 6 weeks. Women were asked to complete forms of Incontinence Impact Questionnaire (IIQ-7) and the Urogenital Distress Inventory (UDI-6), Incontinence Quality of Life (I-QOL), and Overactive Bladder (OAB-V3) before starting the program and again at the end of the 6-week program. Changes from baseline were compared in both groups and between the two groups.

Detailed description: Urinary incontinence (UI) is a chronic condition with involuntary urine loss. Urgency urinary incontinence (UUI) is a complaint of involuntary loss of urine associated with urgency; stress urinary incontinence (SUI) is a complaint of involuntary urine leaks out on effort or physical exertion including sporting activities, or on sneezing or coughing. In the mixed type of urinary incontinence (MUI) complaints coexist both in stress and urgency.

Although urinary incontinence is not a life-threatening condition, the feeling of discomfort caused by constant wetness, irritation, and the fear of odor affects the daily and social activities of in patients.

The abdominal-pelvic cavity contains most of the internal organs, is bounded by the diaphragm above, abdominal muscles anterior and lateral, thoracolumbar fascia and dorsal muscles in the back, and pelvic floor in the lower part. The respiratory diaphragm forms the roof of the abdomina-pelvic cavity and the pelvic floor forms the base. The diaphragm is the main respiratory muscle, connected to the pelvic floor via the transversalis fascia. The pelvic floor supports internal organs, as well as constrictor and continence mechanisms of the urethral, anal and vaginal orifices in females.

Musculofascial support is provided by the pelvic floor forms a hammock onto which the urethra is compressed during increases in intra-abdominal pressure. When intraabdominal pressure increases, intra-abdominal contents downward momentum is arrested by stretch resistance of the pelvic floor structures. At this time, the proximal intraabdominal portion of the urethra is compressed against the underlying supporting layer, which consists of the endopelvic fascia, vagina, and pelvic floor.

Pelvic floor muscle (PFM) exercises, defined by Arnold H. Kegel, aims to regain support to the urinary organs by actively functioning the pelvic floor muscles. Previous researches show that PFM exercises are an effective treatment for UI and improve the quality of life (Qol) of in women. It is currently used as the first choice in conservative treatment of incontinence. However, PFM exercises may be encountered with some difficulties in order to understanding and performing by patients.

Talas et al. showed that the pelvic floor moves in the craniocaudal direction parallel to the diaphragm during respiration. In this study, they suggested that during expiration, the pelvic floor muscles contract together with the abdominal muscles, pushing the abdominal organs up, pushing the intra-abdominal pressure (IAP) to towards the diaphragm.

In this study, the investigators hypothesized that the patients can improve pelvic floor function by performing DB exercises, indirectly via the facial and functional connection between the diaphragm and PFM, and incontinence could be reduced.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of urinary incontinence
* Urinary leakage at least 3 months
* Not received physiotherapy before

Exclusion Criteria:

* Pregnancy
* Postpartum period (6 weeks after delivery)
* Detrusor hyperreflexia
* Menopause
* Hormonal therapy
* Active vaginal lesion or infection
* Urinary infection
* Prior pelvic surgery
* Organ prolapse
* Chronic pelvic pain
* Sexual disorders
* Neurological problem

Primary outcomes:
measure: Change from baseline Incontinence Impact Questionnaire (IIQ-7) scores of women who performed diaphragmatic breathing exercises at 6 weeks
timeFrame: 6 weeks
measure: Change from baseline the Urogenital Distress Inventory (UDI-6) scores of women who performed diaphragmatic breathing exercises at 6 weeks
timeFrame: 6 weeks
measure: Change from baseline The Incontinence Quality of Life (I-QOL) scores of women who performed diaphragmatic breathing exercises at 6 weeks
timeFrame: 6 weeks
measure: Change from baseline Overactive Bladder (OAB-V3) scores of women who performed diaphragmatic breathing exercises at 6 weeks
timeFrame: 6 weeks
Secondary outcomes:
measure: Change from baseline Incontinence Impact Questionnaire (IIQ-7) scores of women who performed pelvic floor exercises at 6 weeks.
timeFrame: 6 weeks
measure: Change from baseline Urogenital Distress Inventory (UDI-6) scores of women who performed pelvic floor exercises at 6 weeks.
timeFrame: 6 weeks
measure: Change from baseline Incontinence Quality of Life (I-QOL) scores of women who performed pelvic floor exercises at 6 weeks.
timeFrame: 6 weeks
measure: Change from baseline Overactive Bladder (OAB-V3) scores of women who performed pelvic floor exercises at 6 weeks.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol Universty
Study officials:
References:
citation: Toprak N, Sen S, Varhan B. The role of diaphragmatic breathing exercise on urinary incontinence treatment: A pilot study. J Bodyw Mov Ther. 2022 Jan;29:146-153. doi: 10.1016/j.jbmt.2021.10.002. Epub 2021 Oct 20.