Clinical trial NCT06988683: Posture, Core Stabilization, Respiratory Muscle Strength and Quality of Life in Women With Urinary Incontinence
Official title: Investigation of Posture, Core Stabilization, Respiratory Muscle Strength and Function, and Quality of Life in Women With Urinary Incontinence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence (UI)
Keywords: Core stabilization
cough force
posture
respiratory muscle strength
urinary incontinence
maximal expiratory pressure
Lead sponsor: Izmir Democracy University
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: This study, in which we aimed to evaluate individuals diagnosed with urinary incontinence, was conducted in the Gynaecology and Obstetrics outpatient clinic of Buca Seyfi Demirsoy Training and Research Hospital. Individuals diagnosed with UI by an Obstetrics and Gynaecology Specialist were included in the study. Thirty-two volunteer individuals diagnosed with UI who met the inclusion criteria and 30 individuals without urinary incontinence were included in the study.

Brief summary: When the literature was examined, it was observed that there were studies on parameters such as quality of life, pelvic floor muscle strength in women with urinary incontinence, but there were not enough studies on posture, respiratory function, constipation and cough strength. Therefore, in this study, the researchers aimed to investigate posture, constipation, core muscle stabilisation, respiratory muscle strength and function, cough strength and quality of life of women with urinary incontinence and to compare these parameters with women without urinary incontinence.

Detailed description: Urinary incontinence (UI) is involuntary urinary leakage and may lead to social and economic problems. There are different types of UI such as stress type, urge, mixed type. Risk factors include age, gender, genetics, menopause, obesity, labour and surgical history. Posture is the position of the body during movement or posture and can also be defined as muscle balance. Studies have reported that there may be a relationship between UI and respiratory problems and postural motor control disorder. Various methods are used in posture assessment, but there is no study evaluating posture with artificial intelligence in women with UI in the literature.Constipation is a particularly serious risk for the development of stress urinary incontinence (SUI). Severe constipation in women leads to differences in the neural function of the pelvic floor by reducing the neural effect of the external anal sphincter and pelvic floor muscles (PFM). Many conditions that increase intra-abdominal pressure (IAB) cause the onset or development of UI. Constipation also leads to an increase in intra-abdominal pressure and thus an increase in intra-bladder pressure. Recently, researchers have investigated the relationship between constipation and urinary incontinence, but the results have been inconsistent. Core stabilisation is the ability to regulate the posture and movement of the body over the pelvis. During forced exhalation activities (Valsalva, coughing, laughing, etc.), the pelvic floor muscles (PFM), abdominal muscles and diaphragm work together to increase intra-abdominal pressure and prevent incontinence. The trunk stabilisation muscles work in concert to keep the abdomen and lumbopelvic region stable by regulating intra-abdominal pressure during various activities of daily living. The activity of these muscles alters intra-abdominal pressure, which in turn can affect the activity of the pelvic floor muscles. Cough is associated with urinary incontinence in women by affecting the concerted contraction of thoracic, abdominal and pelvic muscles. Women with chronic cough are 55-63.3% more likely to develop severe UI than women without chronic cough. Chronic cough has been shown to be one of the common risk factors for UI, along with advanced age, high BMI, history of vaginal delivery and surgical interventions. Urinary incontinence is a public health problem that seriously affects women's quality of life and social participation, as well as being common among older women. UI has a negative impact on individuals' sleep, sexual function, work performance and psychosocial aspects. As symptoms increase, quality of life decreases, but women usually realise the effects of UI years later by seeking professional help. When the literature was reviewed, it was observed that there were studies on parameters such as quality of life and pelvic floor muscle strength in women with urinary incontinence, but there were not enough studies on posture, respiratory functions, constipation and coughing strength. Therefore, in this study, the researchers aimed to investigate posture, constipation, core muscle stabilisation, respiratory muscle strength and function, cough strength and quality of life of women with urinary incontinence and to compare these parameters with women without urinary incontinence.

Eligibility criteria: Inclusion Criteria:

1. Inclusion Criteria for Women with Urinary Incontinence

   * Being diagnosed with urinary incontinence
   * Volunteer to participate in the study
   * To be over 18 years of age
   * To be able to communicate verbally and in written Turkish
2. Inclusion Criteria for Women without Urinary Incontinence

   * No symptoms of urinary incontinence
   * Volunteer to participate in the study
   * To be over 18 years of age
   * Establish written and verbal communication in Turkish

Exclusion Criteria:

* The presence of any pathology that may affect pelvic floor function
* Trauma to the lumbopelvic, abdominal, thoracic or lower extremities within the last six months
* Urinary tract infection
* Grade III or higher urogenital prolapse
* Neurological or psychiatric illness
* Being pregnant

Primary outcomes:
measure: Maximal inspiratory pressure (MIP)
timeFrame: 1 year
measure: Maximal expiratory pressure (MEP)
timeFrame: 1 year
Secondary outcomes:
measure: Forced vital capacity (FVC)
timeFrame: 1 year
measure: Forced expiratory volume in the first second (FEV1)
timeFrame: 1 year
measure: FEV1/FVC
timeFrame: 1 year
measure: Flow rate 25-75% of forced expiratory volume (FEF 25-75%)
timeFrame: 1 year
measure: Peak flow rate (PEF)
timeFrame: 1 year
measure: Posture Assessment
timeFrame: 1 year
measure: Core Stabilization Assessment
timeFrame: 1 year
measure: Cough Force Assessment
timeFrame: 1 year
measure: Modified Constipation Assessment Scale
timeFrame: 1 year
measure: Rome IV Criteria
timeFrame: 1 year
measure: Bristol Stool Scale
timeFrame: 1 year
measure: Urogenital Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7)
timeFrame: 1 year
measure: Global Pelvic Floor Bother Questionnaire
timeFrame: 1 year
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Izmir Democracy University
state: Karabağlar/İzmir
Study officials:
affiliation: İzmir Democracy University
name: Özlem Çinar Özdemir, Prof.Dr
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Steenstrup B, Pelleray M, Cornu JN, Verdun S, Gilliaux M. Neutral posture education during cough can reduce urine leakage in women with cough-related stress urinary incontinence. Prog Urol. 2023 Dec;33(17):1083-1091. doi: 10.1016/j.purol.2023.09.002. Epub 2023 Sep 26.
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