NCT06988683

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 25, 2025

Completed
Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

5 months

First QC Date

January 15, 2025

Last Update Submit

May 21, 2025

Conditions

Keywords

Core stabilizationcough forceposturerespiratory muscle strengthurinary incontinencemaximal expiratory pressure

Outcome Measures

Primary Outcomes (2)

  • Maximal inspiratory pressure (MIP)

    The MIP which shows respiratory muscle strength will be evaluated using a portable mouth pressure measuring device based on American Thoracic Society and European Respiratory Society criteria.

    1 year

  • Maximal expiratory pressure (MEP)

    The MEP which shows respiratory muscle strength will be evaluated using a portabl mouth pressure measuring device based on American Thoracic Society and European Respiratory Society criteria.

    1 year

Secondary Outcomes (13)

  • Forced vital capacity (FVC)

    1 year

  • Forced expiratory volume in the first second (FEV1)

    1 year

  • FEV1/FVC

    1 year

  • Flow rate 25-75% of forced expiratory volume (FEF 25-75%)

    1 year

  • Peak flow rate (PEF)

    1 year

  • +8 more secondary outcomes

Study Arms (2)

Study Group (Urinary incontinance)

The study included 32 volunteer individuals who were diagnosed with urinary Incontinance and fulfilled the inclusion criteria. Pad test was applied to evaluate the degree of urinary incontinence of the patients. Posture analyses of the individuals were evaluated with Fizyosoft Becure Mobile Posture Application. Stabiliser Pressure Biofeedback Unit® (BBU) (Chattanooga Medical Suplly Inc, Chattanooga, TN) was used for core muscle stabilisation, Cosmed® Pony FX was used for respiratory muscle strength and functions and ExpiRite Peak Flow Meter (ExpiRite Peak Flow Meter, China) was used for cough strength assessment. Modified Constipation Rating Scale (MCAS), Rome IV Criteria, Bristol Stool Scale (BGS) were used to evaluate constipation, while quality of life and pelvic floor symptoms were evaluated using Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire (IIQ-7) and Global Pelvic Floor Discomfort Questionnaire (GPTRA).

Control Group

The study included 30 asymptomatic volunteers without urinary incontinence without a diagnosis of UI. In this study, demographic information form was used to evaluate the socio-demographic status. Posture analyses of the individuals were evaluated with Fizyosoft Becure Mobile Posture Application. Stabiliser Pressure Biofeedback Unit® (BBU) (Chattanooga Medical Suplly Inc, Chattanooga, TN) was used for core muscle stabilisation, Cosmed® Pony FX was used for respiratory muscle strength and functions and ExpiRite Peak Flow Meter (ExpiRite Peak Flow Meter, China) was used for cough strength assessment. Modified Constipation Rating Scale (MCAS), Rome IV Criteria, Bristol Stool Scale (BGS) were used to evaluate constipation, while quality of life and pelvic floor symptoms were evaluated using Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire (IIQ-7) and Global Pelvic Floor Discomfort Questionnaire (GPTRA).

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Democracy University

Izmir, Karabağlar/İzmir, 35140, Turkey (Türkiye)

Location

Related Publications (5)

  • Talasz H, Kofler M, Kalchschmid E, Pretterklieber M, Lechleitner M. Breathing with the pelvic floor? Correlation of pelvic floor muscle function and expiratory flows in healthy young nulliparous women. Int Urogynecol J. 2010 Apr;21(4):475-81. doi: 10.1007/s00192-009-1060-1. Epub 2009 Dec 8.

  • Stein TA, DeLancey JO. Structure of the perineal membrane in females: gross and microscopic anatomy. Obstet Gynecol. 2008 Mar;111(3):686-93. doi: 10.1097/AOG.0b013e318163a9a5.

  • 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.

  • Shi ZH, Jonkman A, de Vries H, Jansen D, Ottenheijm C, Girbes A, Spoelstra-de Man A, Zhou JX, Brochard L, Heunks L. Expiratory muscle dysfunction in critically ill patients: towards improved understanding. Intensive Care Med. 2019 Aug;45(8):1061-1071. doi: 10.1007/s00134-019-05664-4. Epub 2019 Jun 24.

  • Ptaszkowski K, Paprocka-Borowicz M, Slupska L, Bartnicki J, Dymarek R, Rosinczuk J, Heimrath J, Dembowski J, Zdrojowy R. Assessment of bioelectrical activity of synergistic muscles during pelvic floor muscles activation in postmenopausal women with and without stress urinary incontinence: a preliminary observational study. Clin Interv Aging. 2015 Sep 23;10:1521-8. doi: 10.2147/CIA.S89852. eCollection 2015.

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Özlem Çinar Özdemir, Prof.Dr

    İzmir Democracy University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.Dr

Study Record Dates

First Submitted

January 15, 2025

First Posted

May 25, 2025

Study Start

January 5, 2024

Primary Completion

May 30, 2024

Study Completion

June 24, 2024

Last Updated

May 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations