MenopauseNCT07690137
Pelvic Floor Symptoms Across Menopausel Stages
An observational study of Menopause and Perimenopausal Disorder, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
The menopausal transition is associated with substantial hormonal alterations that may adversely affect lower urinary tract function, bowel function, and sexual health. Although these symptoms are common, few studies have comprehensively evaluated all three pelvic floor compartments across different menopausal stages. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Menopause, Perimenopausal Disorder
- What is being tested?
- Assessment for Lower Urinary Tract Symptoms, Assessment for Bowel Symptoms and Constipation Severity Assessment
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jul 2026to 6 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women aged 40-65 years attending the Gynecology and Obstetrics Outpatient Clinic who are classified as perimenopausal, early postmenopausal, or late postmenopausal according to the STRAW+10 criteria. Participants must have an intact uterus and at least one ovary and be able to read and understand Turkish.
Who may be able to join
- Female
- Age 40-65 years
- Intact uterus and at least one ovary
- Perimenopause or postmenopause according to STRAW+10 criteria
- Able to read and understand Turkish
Who cannot join
- Hormone replacement therapy within the previous 6 months
- Oral contraceptive use
- Antipsychotic medication use
- Previous pelvic surgery
- Neurological or systemic diseases affecting bladder or bowel function
- Active urinary tract or vaginal infection
Show all 9Show fewer
- Pelvic radiotherapy or chemotherapy history
- Active gynecological or urological malignancy
- Alcohol or substance abuse during the previous year
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Bezmialem Vakif University
Istanbul
Betul Cinar, PhD, +90 212 523 22 88 ext. 4649, bcinar@gmail.com
About this study
Official title: Comparison of Lower Urinary Tract Symptoms, Bowel Function, and Sexual Health Across Menopausal Stages in Women
The menopausal transition is associated with substantial hormonal alterations that may adversely affect lower urinary tract function, bowel function, and sexual health. Although these symptoms are common, few studies have comprehensively evaluated all three pelvic floor compartments across different menopausal stages.
The aim of this study is to compare lower urinary tract symptoms, bowel symptoms, and female sexual function among women in the perimenopausal, early postmenopausal, and late postmenopausal stages. In addition, the relationship between menopausal stage and symptom severity will be investigated.
Read the detailed description
Menopause is characterized by estrogen deficiency, resulting in structural and functional alterations in pelvic floor tissues. Lower urinary tract symptoms, bowel dysfunction, and female sexual dysfunction are increasingly recognized as important health concerns during the menopausal transition.
Despite growing evidence regarding individual pelvic floor disorders, few studies have simultaneously evaluated urinary, colorectal, and sexual symptoms across different menopausal stages.
This study will classify women according to STRAW+10 criteria into:
Perimenopause Early postmenopause Late postmenopause
Participants will undergo a single assessment session. Demographic information together with validated questionnaires will be collected. No intervention or treatment will be provided.
- Conditions
- Menopause, Perimenopausal Disorder
- Being tested
- Assessment for Lower Urinary Tract Symptoms, Assessment for Bowel Symptoms, Constipation Severity Assessment, Sexual Function Assessment
- Keywords
- Menopausal transition, Lower urinary tract symptoms, Bowel functions, Sexual functions
- Medical subject headings
- Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment for Lower Urinary Tract SymptomsOther
Lower urinary tract symptoms will be assessed using the validated Bristol Female Lower Urinary Tract Symptoms questionnaire. Higher scores indicate greater symptom severity and poorer urinary health-related quality of life.
Assessment for Bowel SymptomsOther
Bowel symptoms and colorectal-anal distress will be evaluated using the Colorectal Anal Distress Inventory-8. Higher scores indicate greater symptom severity and distress related to bowel dysfunction.
Constipation Severity AssessmentOther
Constipation severity will be assessed using the Cleveland Clinic Constipation Score. Higher scores represent more severe constipation symptoms.
Sexual Function AssessmentOther
Female sexual function will be assessed using the Female Sexual Function Index, a validated questionnaire evaluating desire, arousal, lubrication, orgasm, satisfaction, and pain. Higher scores indicate better sexual function.
| Study group | Role | What they receive |
|---|---|---|
| Perimenopause | Perimenopausal women according to STRAW+10 criteria Receives: Other: Assessment for Lower Urinary Tract Symptoms; Other: Assessment for Bowel Symptoms; Other: Constipation Severity Assessment; Other: Sexual Function Assessment | |
| Early postmenopause | Early postmenopausal women according to STRAW+10 criteria Receives: Other: Assessment for Lower Urinary Tract Symptoms; Other: Assessment for Bowel Symptoms; Other: Constipation Severity Assessment; Other: Sexual Function Assessment | |
| Late postmenopause | Late postmenopausal women according to STRAW+10 criteria Receives: Other: Assessment for Lower Urinary Tract Symptoms; Other: Assessment for Bowel Symptoms; Other: Constipation Severity Assessment; Other: Sexual Function Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bristol Female Lower Urinary Tract Symptoms (BFLUTS) Score
Lower urinary tract symptoms will be assessed using the validated Bristol Female Lower Urinary Tract Symptoms questionnaire. Higher scores indicate greater symptom severity and poorer urinary health-related quality of life
Measured: Baseline (single assessment)
Secondary outcomes (4)
Colorectal Anal Distress Inventory-8 (CRADI-8)
Bowel symptoms and colorectal-anal distress will be evaluated using the Colorectal Anal Distress Inventory-8. Higher scores indicate greater symptom severity and distress related to bowel dysfunction.
Measured: Baseline (single assessment)
Cleveland Clinic Constipation Score
Constipation severity will be assessed using the Cleveland Clinic Constipation Score. Higher scores represent more severe constipation symptoms.
Measured: Baseline (single assessment)
Bristol Stool Form Scale
The Bristol Stool Form Scale is a 7-category scale ranging from Type 1 (hard stools) to Type 7 (watery stools). Values range from 1 to 7. Lower scores indicate harder stool consistency, whereas higher scores indicate looser stool consistency.
Measured: Baseline (single assessment)
Female Sexual Function Index
Female sexual function will be assessed using the Female Sexual Function Index, a validated questionnaire evaluating desire, arousal, lubrication, orgasm, satisfaction, and pain. Higher scores indicate better sexual function.
Measured: Baseline (single assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start6 Jul 2026 (estimated)
- Primary completion6 Sep 2026 (estimated)
- Study completion6 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Çınar, Bezmialem Vakif University
- Investigators
- Betul Cinar, PhD, Study chair, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07690137
- Sponsor's protocol ID
- bvubcinar05
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Lower Urinary Tract Symptoms, Bowel Function, and Sexual Health Across Menopausal Stages in Women
- ClinicalTrials.gov ID
- NCT07690137
- Acronym / sponsor ID
- bvubcinar05
- Conditions
- Menopause, Perimenopausal Disorder
- Keywords
- Menopausal transition, Lower urinary tract symptoms, Bowel functions, Sexual functions
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 6 Jul 2026 (estimated)
- Primary completion
- 6 Sep 2026 (estimated)
- Study completion
- 6 Oct 2026 (estimated)
- First posted
- 8 Jul 2026 (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.
The menopausal transition is associated with substantial hormonal alterations that may adversely affect lower urinary tract function, bowel function, and sexual health. Although these symptoms are common, few studies have comprehensively evaluated all three pelvic floor compartments across different menopausal stages.
The aim of this study is to compare lower urinary tract symptoms, bowel symptoms, and female sexual function among women in the perimenopausal, early postmenopausal, and late postmenopausal stages. In addition, the relationship between menopausal stage and symptom severity will be investigated.
Detailed description
Menopause is characterized by estrogen deficiency, resulting in structural and functional alterations in pelvic floor tissues. Lower urinary tract symptoms, bowel dysfunction, and female sexual dysfunction are increasingly recognized as important health concerns during the menopausal transition.
Despite growing evidence regarding individual pelvic floor disorders, few studies have simultaneously evaluated urinary, colorectal, and sexual symptoms across different menopausal stages.
This study will classify women according to STRAW+10 criteria into:
Perimenopause Early postmenopause Late postmenopause
Participants will undergo a single assessment session. Demographic information together with validated questionnaires will be collected. No intervention or treatment will be provided.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Perimenopause | – | Other: Assessment for Lower Urinary Tract Symptoms, Other: Assessment for Bowel Symptoms, Other: Constipation Severity Assessment, Other: Sexual Function AssessmentPerimenopausal women according to STRAW+10 criteria |
| Early postmenopause | – | Other: Assessment for Lower Urinary Tract Symptoms, Other: Assessment for Bowel Symptoms, Other: Constipation Severity Assessment, Other: Sexual Function AssessmentEarly postmenopausal women according to STRAW+10 criteria |
| Late postmenopause | – | Other: Assessment for Lower Urinary Tract Symptoms, Other: Assessment for Bowel Symptoms, Other: Constipation Severity Assessment, Other: Sexual Function AssessmentLate postmenopausal women according to STRAW+10 criteria |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women aged 40-65 years attending the Gynecology and Obstetrics Outpatient Clinic who are classified as perimenopausal, early postmenopausal, or late postmenopausal according to the STRAW+10 criteria. Participants must have an intact uterus and at least one ovary and be able to read and understand Turkish.
Key inclusion criteria (5 listed)
- Female
- Age 40-65 years
- Intact uterus and at least one ovary
- Perimenopause or postmenopause according to STRAW+10 criteria
- Able to read and understand Turkish
Key exclusion criteria (9 listed)
- Hormone replacement therapy within the previous 6 months
- Oral contraceptive use
- Antipsychotic medication use
- Previous pelvic surgery
- Neurological or systemic diseases affecting bladder or bowel function
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 |
|---|---|---|
| Assessment for Lower Urinary Tract SymptomsLower urinary tract symptoms will be assessed using the validated Bristol Female Lower Urinary Tract Symptoms questionnaire. Higher scores indicate greater symptom severity and poorer urinary health-related quality of life. | Other | Early postmenopause, Late postmenopause, Perimenopause |
| Assessment for Bowel SymptomsBowel symptoms and colorectal-anal distress will be evaluated using the Colorectal Anal Distress Inventory-8. Higher scores indicate greater symptom severity and distress related to bowel dysfunction. | Other | Early postmenopause, Late postmenopause, Perimenopause |
| Constipation Severity AssessmentConstipation severity will be assessed using the Cleveland Clinic Constipation Score. Higher scores represent more severe constipation symptoms. | Other | Early postmenopause, Late postmenopause, Perimenopause |
| Sexual Function AssessmentFemale sexual function will be assessed using the Female Sexual Function Index, a validated questionnaire evaluating desire, arousal, lubrication, orgasm, satisfaction, and pain. Higher scores indicate better sexual function. | Other | Early postmenopause, Late postmenopause, Perimenopause |
Primary outcome
Bristol Female Lower Urinary Tract Symptoms (BFLUTS) Score
Time frame: Baseline (single assessment)
Lower urinary tract symptoms will be assessed using the validated Bristol Female Lower Urinary Tract Symptoms questionnaire. Higher scores indicate greater symptom severity and poorer urinary health-related quality of life
4 secondary outcomes
Colorectal Anal Distress Inventory-8 (CRADI-8)
Time frame: Baseline (single assessment)
Cleveland Clinic Constipation Score
Time frame: Baseline (single assessment)
Bristol Stool Form Scale
Time frame: Baseline (single assessment)
Female Sexual Function Index
Time frame: Baseline (single assessment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Betul Cinar, PhD study chair
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopause and Perimenopausal Disorder, run by Bezmialem Vakif 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 9 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: opening soon, as of the sponsor's last update on 9 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Betul CINAR, PhD (+905327879969, betulbirik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bristol Female Lower Urinary Tract Symptoms (BFLUTS) Score (time frame: Baseline (single assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2026.