Genitourinary Syndrome of MenopauseNCT06034483
Effects of Pelvic Floor Muscle Training With Patient Education in Genitourinary Syndrome of Menopause
A study testing Pelvic floor exercise training and Patient education in people with Genitourinary Syndrome of Menopause, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 75 years, women only
- Conditions the study is for
- Genitourinary Syndrome of Menopause
- What is being tested?
- Pelvic floor exercise training and Patient education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jan 2024to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 75 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Genitourinary Syndrome of Menopause
- Being tested
- Pelvic floor exercise training, Patient education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor exercise trainingOther
- 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 educationOther
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 (GSM)
- The effect of MGS on sexual function cycle and sexual function,
- Conservative recommendations on MGS management
- Explaining genital and pelvic floor anatomy and function and recommendations for pelvic floor health.
- Sexual response cycle, basic sexual counseling, the role of pelvic floor and GSM in sexual function The training will take approximately 1 hour and the training will be repeated at the end of the 1st month.
| Study group | Role | What they receive |
|---|---|---|
| Patient education+Pelvic Floor Muscle Training | Experimental | progressive pelvic floor muscle training for 8 weeks Receives: Other: Pelvic floor exercise training; Other: Patient education |
| Patient Education | Active comparator | Patient education includes menopausal, sexual health, pelvic floor health and lifestyle issues. Receives: Other: Patient education |
What is being measured
The primary outcome is the main question the study is designed to answer.
vulvovaginal symptoms
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.
Measured: change in severity of vulvovaginal symptoms from baseline up to end of 8th weeks
urinary symptoms
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.
Measured: change in severity of urinary symptoms from baseline up to end of 8th weeks
Secondary outcomes (4)
Pelvic floor muscle function
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.
Measured: change in pelvic floor muscle strength from baseline to end of 8th weeks
Pelvic floor muscle strength
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.
Measured: change in pelvic floor muscle strength from baseline to end of 8th weeks
Urinary symptoms
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.
Measured: change in degree of discomfort associated with urinary symptoms from baseline to end of 8th weeks
Quality of life assessment
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.
Measured: change in quality of life in postmenopausal period from baseline to end of 8th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start3 Jan 2024
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Genitourinary Syndrome of MenopauseStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SERAP ÖZGÜL, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06034483
- Sponsor's protocol ID
- 2022/188
- Status last verified
- Jun 2026
- First submitted
- 6 Sep 2023
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31133219Mercier 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.
PubMed 32105155Mercier 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.
PubMed 27219835
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pelvic Floor Muscle Training With Patient Education in Genitourinary Syndrome of Menopause
- ClinicalTrials.gov ID
- NCT06034483
- Acronym / sponsor ID
- 2022/188
- Conditions
- Genitourinary Syndrome of Menopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient education+Pelvic Floor Muscle Training | Experimental | Other: Pelvic floor exercise training, Other: Patient educationprogressive pelvic floor muscle training for 8 weeks |
| Patient Education | Active comparator | Other: Patient educationPatient education includes menopausal, sexual health, pelvic floor health and lifestyle issues. |
Who may qualify
- Ages
- Up to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | Patient education+Pelvic Floor Muscle Training |
| Patient educationIn 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 (GSM) * The effect of MGS on sexual function cycle and sexual function, * Conservative recommendations on MGS management * Explaining genital and pelvic floor anatomy and function and recommendations for pelvic floor health. * Sexual response cycle, basic sexual counseling, the role of pelvic floor and GSM in sexual function The training will take approximately 1 hour and the training will be repeated at the end of the 1st month. | Other | Patient Education, Patient education+Pelvic Floor Muscle Training |
Primary outcome
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.
4 secondary outcomes
Pelvic floor muscle function
Time frame: change in pelvic floor muscle strength from baseline to end of 8th weeks
Pelvic floor muscle strength
Time frame: change in pelvic floor muscle strength from baseline to end of 8th weeks
Urinary symptoms
Time frame: change in degree of discomfort associated with urinary symptoms from baseline to end of 8th weeks
Quality of life assessment
Time frame: change in quality of life in postmenopausal period from baseline to end of 8th weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Background: PubMed 31133219Mercier 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.
- Background: PubMed 32105155Mercier 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.
- Background: PubMed 27219835Mercier 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor exercise training and Patient education in people with Genitourinary Syndrome of Menopause, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vulvovaginal symptoms (time frame: change in severity of vulvovaginal symptoms from baseline up to end of 8th weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06034483, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.