Clinical trial NCT06034483: Effects of Pelvic Floor Exercise Training in Postmenopausal Genitourinary Syndrome
Official title: Effects of Pelvic Floor Exercise Training in Postmenopausal Genitourinary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Genitourinary Syndrome of Menopause
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 50
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: vulvovaginal symptoms
timeFrame: change in severity of vulvovaginal symptoms from baseline up to end of 8th weeks
measure: urinary symptoms
timeFrame: change in severity of urinary symptoms from baseline up to end of 8th weeks
Secondary outcomes:
measure: Pelvic floor muscle function and strength
timeFrame: change in pelvic floor muscle strength from baseline to end of 8th weeks
measure: Pelvic floor muscle strength
timeFrame: change in pelvic floor muscle strength from baseline to end of 8th weeks
measure: The daily effect of vaginal aging
timeFrame: change in the effects of menopause specific vaginal symptoms over the last 4 weeks from baseline to the 8th weeks
measure: Urinary symptoms
timeFrame: change in degree of discomfort associated with urinary symptoms from baseline to end of 8th weeks
measure: Quality of life assessment
timeFrame: change in quality of life in postmenopausal period from baseline to end of 8th weeks
Other outcomes:
Locations:
city: Düzce
country: Turkey
facility: Gizem Taşkıran
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.