Effects of Pelvic Floor Exercise Training in Postmenopausal Genitourinary Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-03

Study Completion Date

2024-03-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Genitourinary Syndrome of Menopause

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pelvic Floor Exercise Training

progressive pelvic floor muscle training for 8 weeks

Group Type EXPERIMENTAL

Pelvic floor exercise training

Intervention Type OTHER

* Pelvic floor muscle contraction will be verified with vaginal palpation and a progressive pelvic floor muscle training program will be given.
* In the pelvic floor muscle training program:
* Fast and slow pelvic floor muscle contractions will be taught,
* Training will begin with 3 sets of exercises per day, exercise compliance of individuals will be monitored in the controls to be made every 2 weeks, and the number of exercise sets will be increased by one set.
* 1 set of exercises: It will include 10 fast + 10 continuous (frequent-(3-10 sec) hold-release) contractions.
* Individuals will be tracked with exercise diaries.
* At the end of the 8th week, post-intervention evaluations will be made again.
* The exercise program will be completed with a total of 6 sets of exercises per day (60 fast and 60 slow per day).

Patient/individual education

Intervention Type OTHER

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:

* Explaining menopause and menopausal symptoms
* Defining the Genitourinary Syndrome of Menopause (MGS)
* The effect of MGS on sexual function cycle and sexual function,
* Conservative recommendations on MGS management
* Explaining pelvic floor anatomy and function and recommendations for pelvic floor health.

The training will take approximately 1 hour and the training will be repeated at the end of the 1st month.

Patient/Individual Education

Individual/patient education includes menopause, sexual health, pelvic floor health and lifestyle issues.

Group Type ACTIVE_COMPARATOR

Patient/individual education

Intervention Type OTHER

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:

* Explaining menopause and menopausal symptoms
* Defining the Genitourinary Syndrome of Menopause (MGS)
* The effect of MGS on sexual function cycle and sexual function,
* Conservative recommendations on MGS management
* Explaining pelvic floor anatomy and function and recommendations for pelvic floor health.

The training will take approximately 1 hour and the training will be repeated at the end of the 1st month.

Interventions

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Pelvic floor exercise training

* Pelvic floor muscle contraction will be verified with vaginal palpation and a progressive pelvic floor muscle training program will be given.
* In the pelvic floor muscle training program:
* Fast and slow pelvic floor muscle contractions will be taught,
* Training will begin with 3 sets of exercises per day, exercise compliance of individuals will be monitored in the controls to be made every 2 weeks, and the number of exercise sets will be increased by one set.
* 1 set of exercises: It will include 10 fast + 10 continuous (frequent-(3-10 sec) hold-release) contractions.
* Individuals will be tracked with exercise diaries.
* At the end of the 8th week, post-intervention evaluations will be made again.
* The exercise program will be completed with a total of 6 sets of exercises per day (60 fast and 60 slow per day).

Intervention Type OTHER

Patient/individual education

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:

* Explaining menopause and menopausal symptoms
* Defining the Genitourinary Syndrome of Menopause (MGS)
* The effect of MGS on sexual function cycle and sexual function,
* Conservative recommendations on MGS management
* Explaining pelvic floor anatomy and function and recommendations for pelvic floor health.

The training will take approximately 1 hour and the training will be repeated at the end of the 1st month.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No