Effects of Pelvic Floor Muscle Training With Patient Education in Genitourinary Syndrome of Menopause
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hacettepe University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- vulvovaginal symptoms
Study Overview
Brief Summary
Genitourinary syndrome of menopause (MGS) is a clinical picture accompanied by genital and urinary symptoms and is commonly seen in the postmenopausal period. In the literature, the effects of drug and non-drug methods in the improvement of these symptoms have been investigated in many different designs. There is limited evidence that pelvic floor physiotherapy improves vulvovaginal blood flow with repetitive muscle activation, reduces vulvar irritation with reduction in urinary incontinence episodes, and normalizes pelvic floor muscle tone in the treatment of MGS. In addition, there is no study to the best of our knowledge investigating the effects of pelvic floor muscle exercise training and patient/individual training, in which individuals are informed. Therefore, the aim of this study is to compare the effects of pelvic floor muscle training and patient/individual information training in the presence of a physiotherapist on genitourinary symptoms and quality of life in individuals with GSM and to contribute to science in the light of this information. Before starting the study, the physical (height, body weight) and sociodemographic characteristics (age, marital status, educational status, employment status), medical history and menopausal characteristics of the individuals will be recorded. In addition, the pelvic floor muscle strength of the individuals will be evaluated at the beginning of the study and after the study is completed; genital symptoms, urinary symptoms and quality of life and scales will be questioned. Within the scope of individual/patient information education, menopause and menopause-related complaints, genitourinary (genital, sexual and urinary-related) symptoms of menopause, sexual function, the effect of menopause on sexual functions, recommendations for menopausal symptoms and complaints, and the structure and function of the pelvic floor muscles and pelvic floor muscles. Information will be given including recommendations for base health. This training will be given at the beginning of the study and will be repeated after 4 weeks to increase the benefit of the training. Individuals will be included in the progressive exercise training program within the scope of the pelvic floor muscle exercise training program. In the controls to be made every 15 days, the exercise compliance of the individuals will be monitored and the number of exercises will be increased. Exercise charts will be given in order to increase the adaptation of individuals to exercise and the benefit they will gain from exercise. The estimated time in this study is 8 weeks and it is planned to include 50 volunteers in the study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Child, Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Volunteering to participate in the study and signing the informed consent form,
- •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
Outcomes
Primary Outcomes
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.
urinary symptoms
Time Frame: change in severity of urinary symptoms from baseline up to end of 8th weeks
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.
Secondary Outcomes
- Pelvic floor muscle function and strength(change in pelvic floor muscle strength from baseline to end of 8th weeks)
- Pelvic floor muscle strength(change in pelvic floor muscle strength from baseline to end of 8th weeks)
- The daily effect of vaginal aging(change in the effects of menopause specific vaginal symptoms over the last 4 weeks from baseline to the 8th weeks)
- Urinary symptoms(change in degree of discomfort associated with urinary symptoms from baseline to end of 8th weeks)
- Quality of life assessment(change in quality of life in postmenopausal period from baseline to end of 8th weeks)
Investigators
SERAP ÖZGÜL
Prof. Dr
Hacettepe University