Urinary IncontinenceNCT07127549
Core Muscle Strength, Endurance, and Balance in Women With Urinary Incontinence
An observational study of Urinary Incontinence, run by Seda Saka at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 55 years, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Muscle strength, endurance and balance assessment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Jan 2025to 20 Jul 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- Women only
- Adult
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.
Who may be able to join
- Diagnosed with urinary incontinence by a specialist physician
- Native Turkish speaker
- Willing to participate in the study
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Core Muscle Strength, Endurance, and Balance in Women With Urinary Incontinence
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.
- Conditions
- Urinary Incontinence
- Being tested
- Muscle strength, endurance and balance assessment
- Keywords
- urinary incontinence, core strength, core endurance, balance
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle strength, endurance and balance assessmentOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: At the day of enrollment
Assessment of Urinary Incontinence Severity
A 1-hour pad test was used to determine the severity of urinary incontinence.
Measured: 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.
Measured: 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.
Measured: At the day of enrollment
Balance Assessment
The Y Balance Test was used to assess balance.
Measured: At the day of enrollment
Secondary outcomes (2)
International Physical Activity Questionnaire - Short Form (IPAQ-SF)
The IPAQ-SF is a brief self-report questionnaire used to assess the physical activity levels of individuals over the past 7 days. It measures the frequency and duration of walking, moderate-intensity, and vigorous-intensity activities.
Measured: At the day of enrollment
Pelvic Floor Distress Inventory-20 (PFDI-20)
The PFDI-20 is a questionnaire designed to evaluate the presence and severity of pelvic floor distress symptoms, including urinary, colorectal, and pelvic organ prolapse symptoms. It helps assess the impact of these symptoms on a patient's quality of life.
Measured: At the day of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start27 Jan 2025
- Primary completion21 May 2025
- Study completion20 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Seda Saka
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Seda Saka, Halic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127549
- Sponsor's protocol ID
- ssaka9
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Core Muscle Strength, Endurance, and Balance in Women With Urinary Incontinence
- ClinicalTrials.gov ID
- NCT07127549
- Acronym / sponsor ID
- ssaka9
- Conditions
- Urinary Incontinence
- Keywords
- urinary incontinence, core strength, core endurance, balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Seda SakaUniversity, hospital or other
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 21 May 2025 (actual)
- Study completion
- 20 Jul 2025 (actual)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Diagnosed with urinary incontinence by a specialist physician
- Native Turkish speaker
- Willing to participate in the study
Key exclusion criteria (10 listed)
- Pregnant
- Given birth within the past year
- Cooperation problems
- Presence of urinary infection
- Diagnosed with pelvic organ prolapse (POP) stage higher than 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle strength, endurance and balance assessmentAll 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. | Other | – |
Primary outcome
Assessment of Pelvic Floor Muscle Strength
Time frame: At the day of enrollment
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.
Assessment of Urine Flow Rate and Volume
Time frame: At the day of enrollment
A uroflowmetry device was used to assess urine flow rate and volume. A uroflowmetry device was used to assess urine flow rate and volume
Assessment of Urinary Incontinence Severity
Time frame: At the day of enrollment
A 1-hour pad test was used to determine the severity of urinary incontinence.
Assessment of Core Muscle Strength
Time frame: At the day of enrollment
The Stabilizer Pressure Biofeedback Unit® (Chattanooga Medical Supply Inc., Chattanooga, TN) was used to determine the level of core stabilization.
Assessment of Core Endurance and Stability
Time frame: At the day of enrollment
The test protocol developed by McGill and colleagues was applied to measure core endurance.
Balance Assessment
Time frame: At the day of enrollment
The Y Balance Test was used to assess balance.
2 secondary outcomes
International Physical Activity Questionnaire - Short Form (IPAQ-SF)
Time frame: At the day of enrollment
Pelvic Floor Distress Inventory-20 (PFDI-20)
Time frame: At the day of enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Urinary Incontinence
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence, run by Seda Saka at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Pelvic Floor Muscle Strength (time frame: At the day of enrollment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.