- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07320573
Evaluation of Pelvic Floor Muscle Strength in Women With Stress Urinary Incontinence
Evaluation of Pelvic Floor Muscle Strength in Women With Stress Urinary Incontinence Using Two Different EMG Methods
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Pelvic floor muscle strength will be assessed by vaginal palpation in the women included in the study. Then, patients will be placed in a hook position for EMG measurement. For superficial measurement, electrodes will be placed on the levator ani muscle on either side, and then the first assessment will be performed in 3 trials consisting of 5 seconds of contraction followed by 5 seconds of rest, and the second assessment in 3 trials consisting of 2 seconds of contraction followed by 5 seconds of rest.
Measurement with an intervaginal electrode will also be performed in the supine hook position, using a passive electrode and an active vaginal probe. Lubricant gel will be applied to the vaginal probe before insertion into the vagina, and the passive electrode will be placed on the inner surface of the right thigh (adductor muscle group). Two different protocols will be used for assessment. The first assessment will consist of 3 trials of 5 seconds of contraction followed by 5 seconds of rest, and the second assessment will consist of 3 trials of 2 seconds of contraction followed by 5 seconds of rest. A 10-minute rest period will be included between measurements. The ICIQ-SF questionnaire will also be used to determine the type and degree of incontinence. Participants will be asked to answer the questions considering the last two weeks. A score will then be assigned.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: ESRA BAYRAMOĞLU DEMİRDÖĞEN, PHD
- Phone Number: 0542 696 11 69
- Email: fzt.esrabayramoglu@gmail.com
Study Locations
-
-
Centre
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Kırşehir, Centre, Turkey (Türkiye), 40000
- Kirşehir Ahi Evran University Physical Therapy and Rehabilitation Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Being over 18 years of age
- Having stress urinary incontinence
- Being willing to participate in the study
Exclusion Criteria:
- Unwillingness to continue working
- Presence of a neurological disease
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
stress urinary incontinence
Pelvic floor muscle strength will be measured superficially, intravaginally, and digitally.
|
Muscle strength values will be obtained using surface electrodes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pelvic floor muscle strength
Time Frame: day 1
|
muscle strength and endurance durations
|
day 1
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KAEU-EBAYRAMOGLUD-004
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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