NCT07127549

Brief Summary

Urinary incontinence (UI) is defined as the involuntary loss of urine that occurs outside the individual's control and negatively affects both hygiene and social life. Research indicates that individuals with UI experience decreased core muscle strength and endurance, which may also lead to changes in balance parameters. Therefore, the aim of this study was to investigate core muscle strength, endurance, and balance parameters in women with UI, taking the type of UI into consideration. This study was conducted between January 2025 and April 2025 at the Urogynecology Clinic of Başakşehir Çam and Sakura City Hospital in Istanbul, with patients diagnosed with UI by a specialist physician. A total of 32 participants were included. All participants were administered a demographic assessment form; the International Physical Activity Questionnaire-Short Form (IPAQ-SF) to assess physical activity level; the Pelvic Floor Distress Inventory (PFDI-20) and all of its subscales to evaluate the severity of symptoms associated with pelvic floor distress; urodynamic measurement; a pad test to assess the severity of UI; a perineometer device to evaluate pelvic floor muscle (PFM) strength; the Sahrmann five-level core stabilization test and the Stabilizer Pressure Biofeedback Unit to assess core muscle strength; McGill's Trunk Endurance Tests for core endurance; and the Y Balance Test to assess balance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2025

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 27, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2025

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 17, 2025

Completed
Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

August 11, 2025

Last Update Submit

August 21, 2025

Conditions

Keywords

urinary incontinencecore strengthcore endurancebalance

Outcome Measures

Primary Outcomes (6)

  • Assessment of Pelvic Floor Muscle Strength

    a previously validated perineometer with good inter-rater reliability and reproducibility was used to assess pelvic floor muscle strength. a previously validated perineometer with good inter-rater reliability and reproducibility was used to assess pelvic floor muscle strength. A previously validated perineometer with good inter-rater reliability and reproducibility was used to assess pelvic floor muscle strength.

    At the day of enrollment

  • Assessment of Urine Flow Rate and Volume

    A uroflowmetry device was used to assess urine flow rate and volume. A uroflowmetry device was used to assess urine flow rate and volume

    At the day of enrollment

  • Assessment of Urinary Incontinence Severity

    A 1-hour pad test was used to determine the severity of urinary incontinence.

    At the day of enrollment

  • Assessment of Core Muscle Strength

    The Stabilizer Pressure Biofeedback Unit® (Chattanooga Medical Supply Inc., Chattanooga, TN) was used to determine the level of core stabilization.

    At the day of enrollment

  • Assessment of Core Endurance and Stability

    The test protocol developed by McGill and colleagues was applied to measure core endurance.

    At the day of enrollment

  • Balance Assessment

    The Y Balance Test was used to assess balance.

    At the day of enrollment

Secondary Outcomes (2)

  • International Physical Activity Questionnaire - Short Form (IPAQ-SF)

    At the day of enrollment

  • Pelvic Floor Distress Inventory-20 (PFDI-20)

    At the day of enrollment

Interventions

All participants were administered a demographic assessment form; the International Physical Activity Questionnaire-Short Form (IPAQ-SF) to assess physical activity level; the Pelvic Floor Distress Inventory (PFDI-20) and all of its subscales to evaluate the severity of symptoms associated with pelvic floor distress; urodynamic measurement; a pad test to assess the severity of UI; a perineometer device to evaluate pelvic floor muscle (PFM) strength; the Sahrmann five-level core stabilization test and the Stabilizer Pressure Biofeedback Unit to assess core muscle strength; McGill's Trunk Endurance Tests for core endurance; and the Y Balance Test to assess balance.

Eligibility Criteria

Age35 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All patients who applied to the Urogynecology Clinic at Başakşehir Çam and Sakura City Hospital and were diagnosed with urinary incontinence by a specialist physician constitute the population of the study. The sample of the study consists of 32 women from this population who met the inclusion and exclusion criteria and agreed to participate in the study.

You may qualify if:

  • Diagnosed with urinary incontinence by a specialist physician
  • Native Turkish speaker
  • Willing to participate in the study

You may not qualify if:

  • Pregnant
  • Given birth within the past year
  • Cooperation problems
  • Presence of urinary infection
  • Diagnosed with pelvic organ prolapse (POP) stage higher than 2
  • History of pelvic surgery
  • Presence of dizziness, vertigo, tinnitus, hearing loss, or ear fullness (uncontrolled vestibulopathies)
  • Use of medications that affect balance
  • Resistance to digital vaginal palpation or insertion of a perineometer into the vagina
  • Orthopedic, cognitive, cardiac, or neurological conditions that may prevent participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Halic University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Muscle Strength

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

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosisMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator, PhD, PT

Study Record Dates

First Submitted

August 11, 2025

First Posted

August 17, 2025

Study Start

January 27, 2025

Primary Completion

May 21, 2025

Study Completion

July 20, 2025

Last Updated

August 28, 2025

Record last verified: 2025-08

Locations