CompletedNot Applicable

Effects of Pelvic Floor Muscle Training With Patient Education in Genitourinary Syndrome of Menopause

Turkey (Türkiye)50 participantsStarted 2024-01-03

Plain-language 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.

Who can participate

Age range

75 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

vulvovaginal symptoms

Timeframe: change in severity of vulvovaginal symptoms from baseline up to end of 8th weeks

urinary symptoms

Timeframe: change in severity of urinary symptoms from baseline up to end of 8th weeks

Trial details

NCT IDNCT06034483

SponsorHacettepe University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-01

View on ClinicalTrials.gov More Genitourinary Syndrome of Menopause trials