- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07690137
Pelvic Floor Symptoms Across Menopausel Stages
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Betul CINAR, PhD
- Phone Number: +905327879969
- Email: betulbirik@gmail.com
Study Contact Backup
- Name: Betul Cinar, PhD
- Phone Number: 4649 +90 212 523 22 88
- Email: bcinar@bezmialem.edu.tr
Study Locations
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-
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Istanbul, Turkey (Türkiye)
- Bezmialem Vakif University
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Contact:
- Betul Cinar, PhD
- Phone Number: 4649 +90 212 523 22 88
- Email: bcinar@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Pelvic radiotherapy or chemotherapy history
- Active gynecological or urological malignancy
- Alcohol or substance abuse during the previous year
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Perimenopause
Perimenopausal women according to STRAW+10 criteria
|
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.
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 will be assessed using the Cleveland Clinic Constipation Score.
Higher scores represent more severe constipation symptoms.
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.
|
|
Early postmenopause
Early postmenopausal women according to STRAW+10 criteria
|
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.
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 will be assessed using the Cleveland Clinic Constipation Score.
Higher scores represent more severe constipation symptoms.
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.
|
|
Late postmenopause
Late postmenopausal women according to STRAW+10 criteria
|
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.
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 will be assessed using the Cleveland Clinic Constipation Score.
Higher scores represent more severe constipation symptoms.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline (single assessment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Colorectal Anal Distress Inventory-8 (CRADI-8)
Time Frame: Baseline (single assessment)
|
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.
|
Baseline (single assessment)
|
|
Cleveland Clinic Constipation Score
Time Frame: Baseline (single assessment)
|
Constipation severity will be assessed using the Cleveland Clinic Constipation Score.
Higher scores represent more severe constipation symptoms.
|
Baseline (single assessment)
|
|
Female Sexual Function Index
Time Frame: Baseline (single assessment)
|
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.
|
Baseline (single assessment)
|
|
Bristol Stool Form Scale
Time Frame: Baseline (single assessment)
|
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.
|
Baseline (single assessment)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Betul Cinar, PhD, Bezmialem Vakif University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- bvubcinar05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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