- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06034483
Effects of Pelvic Floor Exercise Training in Postmenopausal Genitourinary Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Serap Özgül, PhD
- Phone Number: +905339390803
- Email: serapky@yahoo.com
Study Locations
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Düzce, Turkey
- Gizem Taşkıran
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Volunteering to participate in the study and signing the informed consent form,
- Being between the ages of 40-75
- Being in the postmenopausal period (last menstrual period >12 months ago),
- Having at least 1 genital (vaginal dryness, dyspareunia, vulvovaginal itching/irritation, etc.) and urinary symptoms (dysuria, urinary incontinence, etc.),
- Active pelvic floor muscle contraction ability,
- Absence of any mental problem/cooperation problem that prevents completing the study scales.
Exclusion Criteria:
- Presence of vulvo-vaginal dermatological diseases or neoplasia,
- a history of pelvic organ cancer,
- pelvic radiation exposure,
- signs of vaginal or urinary infection,
- history of medical or surgical treatment for urinary incontinence (eg, mid-urethral sling, pubovaginal sling)
- history of pelvic surgery (hysterectomy, pelvic prolapse surgery, etc.)
- presence of advanced pelvic organ prolapse (prolapse stage >stage 2 according to the pelvic organ prolapse staging system),
- presence of morbid obesity (body mass index ≥35 kg/m2),
- the presence of cognitive disorders and neuropsychiatric diseases (Alzheimer's, dementia, Parkinson's, etc.),
- use of antiestrogenic drugs,
- taking hormone replacement therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pelvic Floor Exercise Training
progressive pelvic floor muscle training for 8 weeks
|
In the individual/patient information training, training will be given on menopause, sexual health, pelvic floor health and lifestyle. This training will cover more specifically the following topics:
The training will take approximately 1 hour and the training will be repeated at the end of the 1st month. |
Active Comparator: Patient/Individual Education
Individual/patient education includes menopause, sexual health, pelvic floor health and lifestyle issues.
|
In the individual/patient information training, training will be given on menopause, sexual health, pelvic floor health and lifestyle. This training will cover more specifically the following topics:
The training will take approximately 1 hour and the training will be repeated at the end of the 1st month. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
vulvovaginal symptoms
Time Frame: change in severity of vulvovaginal symptoms from baseline up to end of 8th weeks
|
Vulvovaginal Symptom Questionnaire will be used to evaluate vulvovaginal symptoms severity .
This questionnaire consists of three parts.
The first two sections are answered by all women, regardless of current sexual activity.
The first 7 questions of the questionnaire include the symptom subscale and in the last week; It includes questions about itching, burning, soreness, irritation, dryness, discharge and odor.
The next section of the VSQ assesses the emotional and lifestyle impact of vulvovaginal symptoms during the past week.
In the third part, the effect of vulvovaginal symptoms on sexual function in sexually active women is questioned.
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change in severity of vulvovaginal symptoms from baseline up to end of 8th weeks
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urinary symptoms
Time Frame: change in severity of urinary symptoms from baseline up to end of 8th weeks
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International consultation on incontinence questionnaire short form will be used to evaluate urinary symptoms.
This scale, which measures the severity of urinary incontinence and its effect on quality of life, has four sub-dimensions.
In the first dimension, the frequency of urinary incontinence, the amount of urinary incontinence in the second dimension, the effects of urinary incontinence on daily life in the third dimension, and the situations that cause urinary incontinence in the fourth dimension are questioned.
The first three dimensions are scored in the evaluation.
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change in severity of urinary symptoms from baseline up to end of 8th weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pelvic floor muscle function and strength
Time Frame: change in pelvic floor muscle strength from baseline to end of 8th weeks
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Urinary stop test will be used to question the individual's ability to stop voiding during voiding and to obtain information about the strength of the pelvic floor.
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change in pelvic floor muscle strength from baseline to end of 8th weeks
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Pelvic floor muscle strength
Time Frame: change in pelvic floor muscle strength from baseline to end of 8th weeks
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Digital palpation will be used to obtain information about the person's pelvic floor muscle strength.In digital palpation, the therapist gently inserts index and middle fingers into the vagina, a natural opening of the body, wearing a sterile glove and using lubricating gel.
The patient is asked to squeeze the therapist's fingers as hard as possible.
This method is a painless, easy and practical method for the evaluation of pelvic floor muscle function.
It is a basic assessment method for performing exercises correctly.
The strength of the contraction felt around the finger is scored according to the Modified Oxford Scale.
This six-point scale is graded as 0: No contraction, 1: Vibration, 2: Weak, 3: Moderate, 4: Good, 5: Strong.
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change in pelvic floor muscle strength from baseline to end of 8th weeks
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The daily effect of vaginal aging
Time Frame: change in the effects of menopause specific vaginal symptoms over the last 4 weeks from baseline to the 8th weeks
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The Day-to-Day impact of vaginal aging questionnaire (DIVA) will be used to evaluate the effects of menopause-specific vaginal symptoms over the last 4 weeks.
The questionnaire evaluates daily life activity, emotional/behavioral status, sexual function and self-perception/body image as versatile with 4 sub-headings and 22 Likert-type questions.
Each item is scored between 0-4 (0=not at all, 1=somewhat, 2=moderate, 3=quite, and 4=a lot).
Higher scores indicate a higher impact of vaginal symptoms.
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change in the effects of menopause specific vaginal symptoms over the last 4 weeks from baseline to the 8th weeks
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Urinary symptoms
Time Frame: change in degree of discomfort associated with urinary symptoms from baseline to end of 8th weeks
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The urinary distress inventory will be used to evaluate the urinary symptoms associated with pelvic floor dysfunction and the degree of discomfort associated with these symptoms.
The best score is 0, the worst score is 100.
In other words, the higher the score, the higher the level of discomfort.
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change in degree of discomfort associated with urinary symptoms from baseline to end of 8th weeks
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Quality of life assessment
Time Frame: change in quality of life in postmenopausal period from baseline to end of 8th weeks
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Menopause-specific quality of life(The MENQOL) will be used to evaluate the quality of life of individuals in the menopausal period.
This scale consists of four sub-dimensions, namely vasomotor, psychosocial, physical and sexual dimensions, and 32 questions.
The score of each sub-dimension ranges from 1 to 8, and an increase in the score means that the relevant sub-dimension is more affected.
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change in quality of life in postmenopausal period from baseline to end of 8th weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Mercier J, Morin M, Zaki D, Reichetzer B, Lemieux MC, Khalife S, Dumoulin C. Pelvic floor muscle training as a treatment for genitourinary syndrome of menopause: A single-arm feasibility study. Maturitas. 2019 Jul;125:57-62. doi: 10.1016/j.maturitas.2019.03.002. Epub 2019 Mar 29.
- Mercier J, Morin M, Tang A, Reichetzer B, Lemieux MC, Samir K, Zaki D, Gougeon F, Dumoulin C. Pelvic floor muscle training: mechanisms of action for the improvement of genitourinary syndrome of menopause. Climacteric. 2020 Oct;23(5):468-473. doi: 10.1080/13697137.2020.1724942. Epub 2020 Feb 27.
- Mercier J, Morin M, Lemieux MC, Reichetzer B, Khalife S, Dumoulin C. Pelvic floor muscles training to reduce symptoms and signs of vulvovaginal atrophy: a case study. Menopause. 2016 Jul;23(7):816-20. doi: 10.1097/GME.0000000000000620.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
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
- 2022/188
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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