Urinary Incontinence,StressNCT07387640
Synchronized Core-Pelvic Floor Activation in Urinary Incontinence
A study testing Conventional Pelvic Floor Muscle Training and Pelvic Floor and Core Muscle Co-activation Training in people with Urinary Incontinence,Stress and Stress Urinary Incontinence, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate whether co-activation of the pelvic floor and core muscles improves treatment outcomes in individuals with urinary incontinence. Participants diagnosed with stress, or mixed urinary incontinence will undergo a 12-week pelvic floor physiotherapy program, with or without additional core… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Urinary Incontinence,Stress, Stress Urinary Incontinence, Mixed Incontinence Due to Prolapse of Female Genital Organ
- What is being tested?
- Conventional Pelvic Floor Muscle Training and Pelvic Floor and Core Muscle Co-activation Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Aug 2026to 30 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 65 years
- Diagnosed with stress, urge, or mixed urinary incontinence
- Pelvic floor muscle strength grade ≥ 3 according to the Modified Oxford Scale
- At least one episode of urinary leakage within the last month
Who cannot join
- Pregnancy
- Childbirth within the previous 6 weeks
- Severe pelvic organ prolapse
- Active vaginal or urinary tract infection
- Presence of neurological or psychiatric disorders
- Malignancy
- Inability to cooperate with assessments or interventions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Synchronized Activation of Core and Pelvic Floor Muscles: A More Effective Strategy for Urinary Incontinence?
This study aims to investigate whether co-activation of the pelvic floor and core muscles improves treatment outcomes in individuals with urinary incontinence. Participants diagnosed with stress, or mixed urinary incontinence will undergo a 12-week pelvic floor physiotherapy program, with or without additional core muscle co-activation exercises. Changes in urinary incontinence severity, pelvic floor muscle function, core muscle activation, and quality of life will be evaluated.
Read the detailed description
Urinary incontinence is a prevalent condition that negatively affects quality of life and functional independence. Pelvic floor muscle training (PFMT) is recommended as a first-line conservative treatment. Recent evidence suggests that coordinated activation of the pelvic floor muscles with core muscles, including the transversus abdominis and multifidus, may enhance treatment effectiveness.
This randomized controlled study will include women aged 18-65 years diagnosed with stress or mixed urinary incontinence. Eligible participants will be randomly allocated to one of two groups: a conventional pelvic floor muscle training group (control group) or a pelvic floor muscle training plus core muscle co-activation group (intervention group).
Both groups will participate in a 12-week exercise program performed at least three days per week, including one supervised session and two home-based sessions weekly. Outcome measures will be assessed at baseline and after completion of the intervention. Primary outcomes include urinary incontinence severity, while secondary outcomes include pelvic floor muscle function, core muscle activation assessed by surface electromyography, and quality of life.
- Conditions
- Urinary Incontinence,Stress, Stress Urinary Incontinence, Mixed Incontinence Due to Prolapse of Female Genital Organ, Urinary Incontinence
- Being tested
- Conventional Pelvic Floor Muscle Training, Pelvic Floor and Core Muscle Co-activation Training
- Keywords
- Pelvic floor muscle training, Core stability exercises, Core Muscle Co-activation, Pelvic floor physiotherapy, Surface Electromyography
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Pelvic Floor Muscle TrainingOther
Participants will receive conventional pelvic floor muscle training based on standardized pelvic floor physiotherapy principles. Exercises will be performed for 12 weeks, at least three days per week, including one supervised session and two home-based sessions.
Pelvic Floor and Core Muscle Co-activation TrainingOther
Participants will receive pelvic floor muscle training combined with co-activation exercises targeting core muscles. The program will be conducted for 12 weeks with the same frequency and supervision structure as the control group.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic floor muscle training | Active comparator | Participants will receive conventional pelvic floor muscle training for 12 weeks, at least three days per week Receives: Other: Conventional Pelvic Floor Muscle Training |
| Synchronized Core-Pelvic Floor Muscle Training | Experimental | Participants will receive pelvic floor muscle training combined with co-activation exercises targeting core muscles for 12 weeks at least three days per week Receives: Other: Pelvic Floor and Core Muscle Co-activation Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Consultation on Incontinence Questionnaire
This is a brief patient-reported questionnaire used to assess the frequency, severity, and impact of urinary incontinence on quality of life.
Minimum Score: 0
Maximum Score: 21
Interpretation: Higher scores indicate worse symptoms and a greater impact on quality of life.
Breakdown: The score is the sum of three items: frequency (0-5), amount (0-6), and interference with everyday life (0-10).
Measured: 12 weeks
Secondary outcomes (4)
PERFECT scheme
This is used to evaluate Pelvic Floor Muscle Function. It evaluates four components: Power, Endurance, Repetitions, and Fast contractions. Higher scores indicate better muscle function
Measured: 12 weeks
Surface electromyography
This is used to evaluate Core and Pelvic Floor Muscle Activation
Measured: 12 weeks
Urogenital Distress Inventory (UDI-6)
This questionnaire assesses the degree of bother associated with specific urogenital symptoms (e.g., frequent urination, leakage).
Minimum Score: 0
Maximum Score: 100 (Standardized Scale)
Interpretation: Higher scores indicate worse quality of life (higher distress).
Calculation: There are 6 items. Each is rated 0 (Not at all) to 3 (Greatly). The average score of the items is calculated and then multiplied by 33.33 to convert it to a 0-100 scale.
Measured: 12 weeks
the Incontinence Impact Questionnaire (IIQ-7)
This questionnaire measures the impact of urinary incontinence on activities, roles, and emotional health.
Minimum Score: 0
Maximum Score: 100 (Standardized Scale)
Interpretation: Higher scores indicate worse quality of life (greater negative impact).
Calculation: There are 7 items. Each is rated 0 (Not at all) to 3 (Greatly). Like the UDI-6, the average of the item scores is multiplied by 33.33 to obtain the final 0-100 score.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start30 Aug 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence,StressStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Çınar, Bezmialem Vakif University
- Investigators
- Betül Çınar, Principal investigator, Bezmialem.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387640
- Sponsor's protocol ID
- bvubcinar04
- Status last verified
- Jun 2026
- First submitted
- 28 Jan 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synchronized Activation of Core and Pelvic Floor Muscles: A More Effective Strategy for Urinary Incontinence?
- ClinicalTrials.gov ID
- NCT07387640
- Acronym / sponsor ID
- bvubcinar04
- Conditions
- Urinary Incontinence,Stress, Stress Urinary Incontinence, Mixed Incontinence Due to Prolapse of Female Genital Organ, Urinary Incontinence
- Keywords
- Pelvic floor muscle training, Core stability exercises, Core Muscle Co-activation, Pelvic floor physiotherapy, Surface Electromyography
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 4 Feb 2026 (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.
This study aims to investigate whether co-activation of the pelvic floor and core muscles improves treatment outcomes in individuals with urinary incontinence. Participants diagnosed with stress, or mixed urinary incontinence will undergo a 12-week pelvic floor physiotherapy program, with or without additional core muscle co-activation exercises. Changes in urinary incontinence severity, pelvic floor muscle function, core muscle activation, and quality of life will be evaluated.
Detailed description
Urinary incontinence is a prevalent condition that negatively affects quality of life and functional independence. Pelvic floor muscle training (PFMT) is recommended as a first-line conservative treatment. Recent evidence suggests that coordinated activation of the pelvic floor muscles with core muscles, including the transversus abdominis and multifidus, may enhance treatment effectiveness.
This randomized controlled study will include women aged 18-65 years diagnosed with stress or mixed urinary incontinence. Eligible participants will be randomly allocated to one of two groups: a conventional pelvic floor muscle training group (control group) or a pelvic floor muscle training plus core muscle co-activation group (intervention group).
Both groups will participate in a 12-week exercise program performed at least three days per week, including one supervised session and two home-based sessions weekly. Outcome measures will be assessed at baseline and after completion of the intervention. Primary outcomes include urinary incontinence severity, while secondary outcomes include pelvic floor muscle function, core muscle activation assessed by surface electromyography, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic floor muscle training | Active comparator | Other: Conventional Pelvic Floor Muscle TrainingParticipants will receive conventional pelvic floor muscle training for 12 weeks, at least three days per week |
| Synchronized Core-Pelvic Floor Muscle Training | Experimental | Other: Pelvic Floor and Core Muscle Co-activation TrainingParticipants will receive pelvic floor muscle training combined with co-activation exercises targeting core muscles for 12 weeks at least three days per week |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 18 and 65 years
- Diagnosed with stress, urge, or mixed urinary incontinence
- Pelvic floor muscle strength grade ≥ 3 according to the Modified Oxford Scale
- At least one episode of urinary leakage within the last month
Key exclusion criteria (7 listed)
- Pregnancy
- Childbirth within the previous 6 weeks
- Severe pelvic organ prolapse
- Active vaginal or urinary tract infection
- Presence of neurological or psychiatric disorders
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 |
|---|---|---|
| Conventional Pelvic Floor Muscle TrainingParticipants will receive conventional pelvic floor muscle training based on standardized pelvic floor physiotherapy principles. Exercises will be performed for 12 weeks, at least three days per week, including one supervised session and two home-based sessions. | Other | Pelvic floor muscle training |
| Pelvic Floor and Core Muscle Co-activation TrainingParticipants will receive pelvic floor muscle training combined with co-activation exercises targeting core muscles. The program will be conducted for 12 weeks with the same frequency and supervision structure as the control group. | Other | Synchronized Core-Pelvic Floor Muscle Training |
Primary outcome
International Consultation on Incontinence Questionnaire
Time frame: 12 weeks
This is a brief patient-reported questionnaire used to assess the frequency, severity, and impact of urinary incontinence on quality of life. Minimum Score: 0 Maximum Score: 21 Interpretation: Higher scores indicate worse symptoms and a greater impact on quality of life. Breakdown: The score is the sum of three items: frequency (0-5), amount (0-6), and interference with everyday life (0-10).
4 secondary outcomes
PERFECT scheme
Time frame: 12 weeks
Surface electromyography
Time frame: 12 weeks
Urogenital Distress Inventory (UDI-6)
Time frame: 12 weeks
the Incontinence Impact Questionnaire (IIQ-7)
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Betül Çınar principal investigator
Bezmialem.edu.tr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Pelvic Floor Muscle Training and Pelvic Floor and Core Muscle Co-activation Training in people with Urinary Incontinence,Stress and Stress Urinary Incontinence, run by Bezmialem Vakif University 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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 1 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Betül Çınar (+902125232288 ext. 4648, betulbirik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Consultation on Incontinence Questionnaire (time frame: 12 weeks). 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 1 Jul 2026.