Stress Urinary IncontinenceNCT05193435
Comparison of Stabilization Exercises and Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence
A study testing Pelvic floor exercises and Stabilization exercises in people with Stress Urinary Incontinence, run by Ankara Yildirim Beyazıt University.
Trial summary
The aim of the study was to compare the effects of stabilization exercises and pelvic floor muscle training in women with stress urinary incontinence. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Pelvic floor exercises and Stabilization exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2022to 15 Jun 2023
- Phase
- Interventional
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women between the ages of 18-65 who have symptoms of stress or stress-dominant mixed urinary incontinence, who volunteered to participate in the study
Who cannot join
- Those who are pregnant, have communication and cooperation problems, have a concomitant neurological or rheumatological disease, have a history of surgery involving the abdominal and pelvic regions in the last year, have undergone spine surgery, those diagnosed with pure urge urinary incontinence or mixed type incontinence, those with advanced pelvic organ prolapse, those with a spinal deformity (such as scoliosis), the presence of orthopedic problems in the lower extremities (such as lower extremity shortness, presence of deformity etc.) and vestibular system disorder
Trial locations and contacts
No sites are listed yet.
About this study
The aim of the study was to compare the effects of stabilization exercises and pelvic floor muscle training in women with stress urinary incontinence.
Read the detailed description
Stress urinary incontinence is involuntary urinary incontinence with increased intraabdominal pressure. Different exercise approaches such as pelvic floor exercises and stabilization exercises are used in these patients. There is a need for studies comparing the effects of these exercises.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Pelvic floor exercises, Stabilization exercises
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor exercisesOther
Pelvic floor exercises for types I and II muscle fibers will be performed
Stabilization exercisesOther
Lumbar spinal stabilization exercises will be performed
| Study group | Role | What they receive |
|---|---|---|
| Pelvic floor exercise group | Experimental | Pelvic floor exercises for muscle fiber types I and II will performed 3 days a week for 8 weeks Receives: Other: Pelvic floor exercises |
| Stabilization exercise group | Active comparator | Lumbar spinal stabilization exercises will performed 3 days a week for 8 weeks Receives: Other: Stabilization exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary incontinence severity
Urinary incontinence severity will be measured with A 1-hour pad test
Measured: change from baseline at 8 weeks
Secondary outcomes (8)
Urinary symptoms
Urinary symptoms will be evaluated with International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
Measured: change from baseline at 8 weeks
Life quality
Life quality will be assessed with King's Health Questionnaire.
Measured: change from baseline at 8 weeks
Pelvic floor muscle activation response
Pelvic floor muscle activation response will be measured with a portable EMG-Biofeedback device.
Measured: change from baseline at 8 weeks
Pelvic floor muscle strength
Pelvic floor muscle strength will be evaluated with Modified Oxford Scale
Measured: change from baseline at 8 weeks
Core stability
Core stability will be evaluated with Sahrmann Test using the pressure stabilizer.
Measured: change from baseline at 8 weeks
Balance
Balance will be evaluated with Biodex Balance System as static and dynamic
Measured: change from baseline at 8 weeks
Spinal function
Spinal function will be evaluated with the Spinal Mouse device in standing position.
Measured: change from baseline at 8 weeks
Subjective perception of improvement
Subjective perception of improvement will be measured with a four-point Likert scale.
Measured: After treatment (at 8 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start15 Jan 2022 (estimated)
- Primary completion15 Dec 2022 (estimated)
- Study completion15 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, seyda toprak celenay, Ankara Yildirim Beyazıt University
- Investigators
- Seyda Toprak Celenay, Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193435
- Sponsor's protocol ID
- 2022/01/2
- Status last verified
- Jan 2022
- First submitted
- 2 Jan 2022
- Last updated
- 14 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.
PubMed 39704322
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Stabilization Exercises and Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT05193435
- Acronym / sponsor ID
- 2022/01/2
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 15 Jan 2022 (estimated)
- Primary completion
- 15 Dec 2022 (estimated)
- Study completion
- 15 Jun 2023 (estimated)
- First posted
- 14 Jan 2022 (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.
The aim of the study was to compare the effects of stabilization exercises and pelvic floor muscle training in women with stress urinary incontinence.
Detailed description
Stress urinary incontinence is involuntary urinary incontinence with increased intraabdominal pressure. Different exercise approaches such as pelvic floor exercises and stabilization exercises are used in these patients. There is a need for studies comparing the effects of these exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic floor exercise group | Experimental | Other: Pelvic floor exercisesPelvic floor exercises for muscle fiber types I and II will performed 3 days a week for 8 weeks |
| Stabilization exercise group | Active comparator | Other: Stabilization exercisesLumbar spinal stabilization exercises will performed 3 days a week for 8 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women between the ages of 18-65 who have symptoms of stress or stress-dominant mixed urinary incontinence, who volunteered to participate in the study
Key exclusion criteria (1 listed)
- Those who are pregnant, have communication and cooperation problems, have a concomitant neurological or rheumatological disease, have a history of surgery involving the abdominal and pelvic regions in the last year, have undergone spine surgery, those diagnosed with pure urge urinary incontinence or mixed type incontinence, those with advanced pelvic organ prolapse, those with a spinal deformity (such as scoliosis), the presence of orthopedic problems in the lower extremities (such as lower extremity shortness, presence of deformity etc.) and vestibular system disorder
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 |
|---|---|---|
| Pelvic floor exercisesPelvic floor exercises for types I and II muscle fibers will be performed | Other | Pelvic floor exercise group |
| Stabilization exercisesLumbar spinal stabilization exercises will be performed | Other | Stabilization exercise group |
Primary outcome
Urinary incontinence severity
Time frame: change from baseline at 8 weeks
Urinary incontinence severity will be measured with A 1-hour pad test
8 secondary outcomes
Urinary symptoms
Time frame: change from baseline at 8 weeks
Life quality
Time frame: change from baseline at 8 weeks
Pelvic floor muscle activation response
Time frame: change from baseline at 8 weeks
Pelvic floor muscle strength
Time frame: change from baseline at 8 weeks
Core stability
Time frame: change from baseline at 8 weeks
Balance
Time frame: change from baseline at 8 weeks
Spinal function
Time frame: change from baseline at 8 weeks
Subjective perception of improvement
Time frame: After treatment (at 8 week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Derived from this study: PubMed 39704322Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.
Related trials for Stress Urinary Incontinence
RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Urinary Incontinence,Stress
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Urinary Incontinence Stress
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy
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.
Seyda Toprak Celenay principal investigator
Ankara Yildirim Beyazıt University
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor exercises and Stabilization exercises in people with Stress Urinary Incontinence, run by Ankara Yildirim Beyazıt University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seyda Toprak Celenay (+90312 906 1000, sydtoprak@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary incontinence severity (time frame: change from baseline at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05193435, which also lists 1 linked publication.
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 14 Jan 2022.